Adult HIV Clinical Trials
Lead Research Organisation:
MRC Clinical Trials Unit
Abstract
Combination antiretroviral therapy (ART) for HIV infection is highly effective, but needs to be taken life-long, has some short and long-term side effects and is expensive. This programme has several clinical trials looking at important unanswered questions. |Firstly, it is not clear exactly when is the best time to start ART. A trial called SPARTAC is looking at whether treating with ART is of benefit shortly after someone has first become infected with HIV. The START trial will examine whether people with a high CD4 count (above 500) obtain any benefit from starting ART straight away, rather than waiting until the count declines further.||There may be other ways of treating HIV infection early on that mean that conventional ART can be delayed. The HCQ-01 trial is looking at whether hydroxychloroquine, an anti-inflammatory drug may have a benefit in controlling the immune damage caused by HIV.||The class of drugs called protease inhibitors (PIs), may be able to maintain long term HIV control when used alone (traditionally they are used in combinatino with other drugs). PIVOT is a trial that will find out whether PI monotherapy is just as good as conventional triple therapy in the long-term management of HIV disease and whether it helps to cut down long-term side effects as well as costs.||The MRC EARNEST trial will investigate several novel combinations for second line therapy in Africa, to identify the best standard combination that can be used in public health rollout programmes for HIV treatment.
Technical Summary
This programme aims to address important questions about the best time to start HIV treatment, whether there are alternative aprpoaches using anti-inflammatory drugs, and whether there are alternative strategies to reduce costs and improve long term outcomes.||There are several trials in the programme that address the optimal timing of therapy. The SPARTAC trial has randomised 366 patients with acute HIV infection to ART (12 or 48 weeks) or no ART to determine the time taken for the CD4 count to fall below 350 cells. The trial will report in 2011. The START trial will randomise 4000 patients with CD4 cell counts above 500 cells/mm3 to receive immediate ART or to have treatment deferred until the CD4 count falls below 350 cells. The trial aims to determine what benefits (if any) result from earlier treatment and to assess the health-economic issues around early ART. ||HIV leads to immune activation and increased inflammation, both of which may play a critical role in HIV pathogenesis. The HCQ-01 trial examines whether hydroxychloroquine, a cheap and well tolerated immunomodulatory drug, can decrease immune activation in ART-naive patients with CD4 cell counts above 400 cells. A decrease in immune activation may lead to slowing of disease progression, thereby delaying the timing of starting conventional ART. ||The advent of more potent individual drugs, particularly the protease inhibitors (PIs) means that combination triple therapy may no longer be needed to control HIV viral replication. The PIVOT trial will determine whether PI monotherapy is non-inferior to triple therapy over long-term follow-up, an approach that may reduce long term toxicity as well as result in substantial health economic benefits. The trial has recruited 560 patients at 50 sites across the UK, and will run until 2013. ||There is virtually no evidence from randomised controlled trials to determine the best option for second line therapy in patients who fail treatment with a standard first-line NNRTI-based combination. The Europe-Africa Research Network for Evaluation of Second-line therapy (EARNEST) Trial, will randomise 1200 patients to one of three options: lopinavir/ritonavir with 2 NRTIs (the standard of care) or lopinavir/ritonavir plus raltegravir (a new integrase inhibitor) or lopinavir/ritonavir monotherapy (after a period of induction with raltegravir). The trial will run until 2013.
Organisations
- MRC Clinical Trials Unit (Lead Research Organisation)
- University College London, United Kingdom (Collaboration)
- South Tees Hospitals NHS Foundtn Trust (Collaboration)
- Queen Elizabeth Hospital (Malaysia) (Collaboration)
- Southmead Hospital (Collaboration)
- Joint Clinical Research Center, Kampala (Collaboration)
- Institute of Tropical Medicine (Collaboration)
- Gloucestershire Royal Hospital (Collaboration)
- Royal Free Hospital (Collaboration)
- African Eye Trust (Collaboration)
- National Institute of Health (Collaboration)
- University College Dublin, Ireland (Collaboration)
- University of Bordeaux I, France (Collaboration)
- St Mary's Hospital, London (Collaboration)
- City of Coventry NHS Healthcare Centre (Collaboration)
- Amsterdam Institute for Global Health and Development (AIGHD) (Collaboration)
- National Institute of Health and Medical Research (INSERM) (Collaboration)
- Chelsea and Westminster Hospital NHS Foundation Trust (Collaboration)
- San Raffaele Hospital (Collaboration)
- University of New South Wales (Collaboration)
- MRC/UVRI Uganda Research Unit on AIDS, Uganda (Collaboration)
- National and Kapodistrian University of Athens (Collaboration)
- University of Minnesota, United States (Collaboration)
- Royal Hallamshire Hospital, United Kingdom (Collaboration)
- Ibn Rochd University Hospital (Collaboration)
- University Hospital La Paz (Collaboration)
- St Thomas' Hospital (Collaboration)
- University of Oxford, United Kingdom (Collaboration)
- UK Community Advisory Board UKCAB (Collaboration)
- Washington Dc Va Medical Center (Collaboration)
- Birmingham Heartlands Hospital (Collaboration)
- Imperial College London, United Kingdom (Collaboration)
- St Stephen's AIDS trust (Collaboration)
- North Manchester General Hospital (Collaboration)
- The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust (Collaboration)
- Barts Health NHS Trust, London (Collaboration)
- University of Birmingham, United Kingdom (Collaboration)
- University of Copenhagen, Denmark (Collaboration)
- CINECA (Collaboration)
- Royal Berkshire Hospital (Collaboration)
- Royal Victoria Teaching Hospital (Collaboration)
- University Hospital of Bern (Collaboration)
- Royal Sussex County Hospital (Collaboration)
Publications
Achhra AC
(2012)
Reclassification of risk of death with the knowledge of D-dimer in a cohort of treated HIV-infected individuals.
in AIDS (London, England)
Achhra AC
(2010)
Immunodeficiency and the risk of serious clinical endpoints in a well studied cohort of treated HIV-infected patients.
in AIDS (London, England)
Andrade BB
(2013)
Biomarkers of inflammation and coagulation are associated with mortality and hepatitis flares in persons coinfected with HIV and hepatitis viruses.
in The Journal of infectious diseases
Angus B
(2008)
TILT: a randomized controlled trial of interruption of antiretroviral therapy with or without interleukin-2 in HIV-1 infected individuals.
in AIDS (London, England)
Arenas-Pinto A
(2008)
The risk of developing peripheral neuropathy induced by nucleoside reverse transcriptase inhibitors decreases over time: evidence from the Delta trial.
in Antiviral therapy
Arenas-Pinto A.
(2007)
Risk factors for lactic acidosis and severe hyperlactataemia in HIV-1-infected adults exposed to antiretroviral therapy
in AIDS
Asboe D
(2007)
A virological benefit from an induction/maintenance strategy: the Forte trial.
in Antiviral therapy
Babiker AG
(2013)
Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study.
in Clinical trials (London, England)
Baker JV
(2012)
HIV replication, inflammation, and the effect of starting antiretroviral therapy on plasma asymmetric dimethylarginine, a novel marker of endothelial dysfunction.
in Journal of acquired immune deficiency syndromes (1999)
Baker JV
(2011)
Changes in inflammatory and coagulation biomarkers: a randomized comparison of immediate versus deferred antiretroviral therapy in patients with HIV infection.
in Journal of acquired immune deficiency syndromes (1999)
| Guideline Title | Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents |
| Description | HIV treatment guidelines |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | The findings of the SMART trial have changed the way that HIV is practised internationally. Not only did the trial prove that treatment interruption was harmful, but the trial also demonstrated the importance of previously unrecognised complications of HIV early in the course of disease e.g. cardiovascular events. THis has lead to a change in international guidelines towards earlier treatment. |
| Description | EDCTP |
| Amount | £4,200,000 (GBP) |
| Organisation | Sixth Framework Programme (FP6) |
| Department | European and Developing Countries Clinical Trials Partnership |
| Sector | Public |
| Country | Netherlands |
| Start | |
| Description | HTA |
| Amount | £1,928,677 (GBP) |
| Organisation | National Institute for Health Research |
| Department | Health Technology Assessment Programme (HTA) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2007 |
| End | 02/2014 |
| Description | INSIGHT |
| Amount | $16,153,712 (USD) |
| Organisation | National Institutes of Health (NIH) |
| Sector | Public |
| Country | United States |
| Start | 01/2006 |
| End | 12/2020 |
| Description | NEAT (for NEAT001) |
| Amount | € 872,801 (EUR) |
| Organisation | European Commission |
| Department | EC FP6 Collaborative Projects |
| Sector | Academic/University |
| Country | European Union (EU) |
| Start | 01/2010 |
| End | 08/2013 |
| Description | Wellcome Trust Individual project grant |
| Amount | £246,000 (GBP) |
| Organisation | Wellcome Trust |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| Start | 03/2007 |
| Description | EARNEST |
| Organisation | Cineca |
| Country | Italy |
| Sector | Charity/Non Profit |
| PI Contribution | The Europe - Africa Research Network for Evaluation of Second-line Therapy (EARNEST) is a partnership between 14 African clinical research sites and 6 European organisations, including the MRC CTU. It was funded by the European and Developing Countries Clinical Trials Programme (EDCTP) and European national research funding agencies. The network conducted the EARNEST trial, the definitive clinical trial which aimed to indentify the best antiretroviral therapy for HIV-infected adults and adolescents who need to switch from first-line antiretroviral therapy in a resource limited setting. The trial enrolled 1277 patients from 5 African countries - Malawi, Uganda, Zimbabwe, Kenya and Zambia from April 2010 to April 2011. The first results from the trial were published in the New England Journal of Medicine in 2014 with more results informing how best to deliver second line therapy in resource limited settings to come. EARNEST also aimed to build capacity for conducting clinical trials in Africa through training activities related to the trial, by supporting MSc and PhD training programmes for trial staff, and by enhancing the physical infrastructure at trial sites. It has strengthened African collaborative links and communication through a programme of networking activities. The Chief Investigator of the EARNEST trial, Prof Nick Paton, was a senior scientist at MRC CTU, and the MRC CTU team led on all trial management activities and associated training, statistical analyses and general research management. MRC CTU also organised and managed the work of local trial monitors, again building capacity, and the independent endpoint review committee which review all clinical primary and secondary endpoints. |
| Collaborator Contribution | CINECA in kind contributions towards the database, web community and website. UCD in kind contributions in the form of support and supervision of PhD students. Institute of Tropical Medicine supported the EARNEST Bone Mineral Density Substudy. |
| Impact | Primary 96 week comparison of the randomised arms published in NEJM 2014. Five conference abstracts submitted to CROI 2015. |
| Start Year | 2009 |
| Description | EARNEST |
| Organisation | Institute of Tropical Medicine Antwerp |
| Country | Belgium |
| Sector | Academic/University |
| PI Contribution | The Europe - Africa Research Network for Evaluation of Second-line Therapy (EARNEST) is a partnership between 14 African clinical research sites and 6 European organisations, including the MRC CTU. It was funded by the European and Developing Countries Clinical Trials Programme (EDCTP) and European national research funding agencies. The network conducted the EARNEST trial, the definitive clinical trial which aimed to indentify the best antiretroviral therapy for HIV-infected adults and adolescents who need to switch from first-line antiretroviral therapy in a resource limited setting. The trial enrolled 1277 patients from 5 African countries - Malawi, Uganda, Zimbabwe, Kenya and Zambia from April 2010 to April 2011. The first results from the trial were published in the New England Journal of Medicine in 2014 with more results informing how best to deliver second line therapy in resource limited settings to come. EARNEST also aimed to build capacity for conducting clinical trials in Africa through training activities related to the trial, by supporting MSc and PhD training programmes for trial staff, and by enhancing the physical infrastructure at trial sites. It has strengthened African collaborative links and communication through a programme of networking activities. The Chief Investigator of the EARNEST trial, Prof Nick Paton, was a senior scientist at MRC CTU, and the MRC CTU team led on all trial management activities and associated training, statistical analyses and general research management. MRC CTU also organised and managed the work of local trial monitors, again building capacity, and the independent endpoint review committee which review all clinical primary and secondary endpoints. |
| Collaborator Contribution | CINECA in kind contributions towards the database, web community and website. UCD in kind contributions in the form of support and supervision of PhD students. Institute of Tropical Medicine supported the EARNEST Bone Mineral Density Substudy. |
| Impact | Primary 96 week comparison of the randomised arms published in NEJM 2014. Five conference abstracts submitted to CROI 2015. |
| Start Year | 2009 |
| Description | EARNEST |
| Organisation | National Institute of Health |
| Country | Italy |
| Sector | Public |
| PI Contribution | The Europe - Africa Research Network for Evaluation of Second-line Therapy (EARNEST) is a partnership between 14 African clinical research sites and 6 European organisations, including the MRC CTU. It was funded by the European and Developing Countries Clinical Trials Programme (EDCTP) and European national research funding agencies. The network conducted the EARNEST trial, the definitive clinical trial which aimed to indentify the best antiretroviral therapy for HIV-infected adults and adolescents who need to switch from first-line antiretroviral therapy in a resource limited setting. The trial enrolled 1277 patients from 5 African countries - Malawi, Uganda, Zimbabwe, Kenya and Zambia from April 2010 to April 2011. The first results from the trial were published in the New England Journal of Medicine in 2014 with more results informing how best to deliver second line therapy in resource limited settings to come. EARNEST also aimed to build capacity for conducting clinical trials in Africa through training activities related to the trial, by supporting MSc and PhD training programmes for trial staff, and by enhancing the physical infrastructure at trial sites. It has strengthened African collaborative links and communication through a programme of networking activities. The Chief Investigator of the EARNEST trial, Prof Nick Paton, was a senior scientist at MRC CTU, and the MRC CTU team led on all trial management activities and associated training, statistical analyses and general research management. MRC CTU also organised and managed the work of local trial monitors, again building capacity, and the independent endpoint review committee which review all clinical primary and secondary endpoints. |
| Collaborator Contribution | CINECA in kind contributions towards the database, web community and website. UCD in kind contributions in the form of support and supervision of PhD students. Institute of Tropical Medicine supported the EARNEST Bone Mineral Density Substudy. |
| Impact | Primary 96 week comparison of the randomised arms published in NEJM 2014. Five conference abstracts submitted to CROI 2015. |
| Start Year | 2009 |
| Description | EARNEST |
| Organisation | University College Dublin |
| Country | Ireland |
| Sector | Academic/University |
| PI Contribution | The Europe - Africa Research Network for Evaluation of Second-line Therapy (EARNEST) is a partnership between 14 African clinical research sites and 6 European organisations, including the MRC CTU. It was funded by the European and Developing Countries Clinical Trials Programme (EDCTP) and European national research funding agencies. The network conducted the EARNEST trial, the definitive clinical trial which aimed to indentify the best antiretroviral therapy for HIV-infected adults and adolescents who need to switch from first-line antiretroviral therapy in a resource limited setting. The trial enrolled 1277 patients from 5 African countries - Malawi, Uganda, Zimbabwe, Kenya and Zambia from April 2010 to April 2011. The first results from the trial were published in the New England Journal of Medicine in 2014 with more results informing how best to deliver second line therapy in resource limited settings to come. EARNEST also aimed to build capacity for conducting clinical trials in Africa through training activities related to the trial, by supporting MSc and PhD training programmes for trial staff, and by enhancing the physical infrastructure at trial sites. It has strengthened African collaborative links and communication through a programme of networking activities. The Chief Investigator of the EARNEST trial, Prof Nick Paton, was a senior scientist at MRC CTU, and the MRC CTU team led on all trial management activities and associated training, statistical analyses and general research management. MRC CTU also organised and managed the work of local trial monitors, again building capacity, and the independent endpoint review committee which review all clinical primary and secondary endpoints. |
| Collaborator Contribution | CINECA in kind contributions towards the database, web community and website. UCD in kind contributions in the form of support and supervision of PhD students. Institute of Tropical Medicine supported the EARNEST Bone Mineral Density Substudy. |
| Impact | Primary 96 week comparison of the randomised arms published in NEJM 2014. Five conference abstracts submitted to CROI 2015. |
| Start Year | 2009 |
| Description | EARNEST |
| Organisation | University Hospital La Paz |
| Country | Spain |
| Sector | Hospitals |
| PI Contribution | The Europe - Africa Research Network for Evaluation of Second-line Therapy (EARNEST) is a partnership between 14 African clinical research sites and 6 European organisations, including the MRC CTU. It was funded by the European and Developing Countries Clinical Trials Programme (EDCTP) and European national research funding agencies. The network conducted the EARNEST trial, the definitive clinical trial which aimed to indentify the best antiretroviral therapy for HIV-infected adults and adolescents who need to switch from first-line antiretroviral therapy in a resource limited setting. The trial enrolled 1277 patients from 5 African countries - Malawi, Uganda, Zimbabwe, Kenya and Zambia from April 2010 to April 2011. The first results from the trial were published in the New England Journal of Medicine in 2014 with more results informing how best to deliver second line therapy in resource limited settings to come. EARNEST also aimed to build capacity for conducting clinical trials in Africa through training activities related to the trial, by supporting MSc and PhD training programmes for trial staff, and by enhancing the physical infrastructure at trial sites. It has strengthened African collaborative links and communication through a programme of networking activities. The Chief Investigator of the EARNEST trial, Prof Nick Paton, was a senior scientist at MRC CTU, and the MRC CTU team led on all trial management activities and associated training, statistical analyses and general research management. MRC CTU also organised and managed the work of local trial monitors, again building capacity, and the independent endpoint review committee which review all clinical primary and secondary endpoints. |
| Collaborator Contribution | CINECA in kind contributions towards the database, web community and website. UCD in kind contributions in the form of support and supervision of PhD students. Institute of Tropical Medicine supported the EARNEST Bone Mineral Density Substudy. |
| Impact | Primary 96 week comparison of the randomised arms published in NEJM 2014. Five conference abstracts submitted to CROI 2015. |
| Start Year | 2009 |
| Description | HCQ |
| Organisation | Chelsea and Westminster Hospital NHS Foundation Trust |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | An Randomised clinical trial to evaluate the efficacy of hydroxychloroquine in decreasing immune activation in asymptomatic HIV-infected patients. The MRC was sponsor of the trial and all responsibilities delegated to the MRC clinical trials unit. The trial team ran all aspects of the trial from regulatory and ethical approval to statistical analysis and writing of the main publication. MRC Clinical Trials Unit have supported the trial to its conclusion. This is because the recruitment period took longer than expected and resulted in patient follow-up continuing beyond the duration of the Wellcome grant. Sites found it harder to recruit to the trial than expected, mainly because patients who have asymptomatic HIV disease have been reluctant to start any medication. In addition these stable patients are seen only a couple of times a year in the clinic. Some of the inclusion criteria have been relaxed where possible (without compromising patient safety) and this improved recruitment. The number of participating sites was been expanded within the UK. This was not extended to sites outside the UK as the grant proposal to Wellcome Trust was not successful. |
| Collaborator Contribution | The primary end point of the study were change in CD8 T-cell activation at week 48 compared to baseline (as shown by a percentage of the cells expressing CD38+ and HLA-DR+). with secondary endpoints looking at efficacy and safety outcome measures. The immunology assays were performed centrally at the Chelsea and Westminster Immunology laboratory under the supervision of Dr Peter Kelleher. |
| Impact | Effects of Hydroxychloroquine on Immune Activation and Disease Progression Among HIV-Infected Patients Not Receiving Antiretroviral Therapy : A Randomized Controlled Trial Nicholas I. Paton, MD, FRCP; Ruth L. Goodall, PhD; David T. Dunn, PhD; Samuel Franzen, BSc; Yolanda Collaco-Moraes, PhD; Brian G. Gazzard, MD, FRCP; Ian G. Williams, MA, FRCP; Martin J. Fisher, FRCP; Alan Winston, MD, MRCP; Julie Fox, MD, MRCP; Chloe Orkin, MRCP; Elbushra A. Herieka, MRCOG; Jonathan G. Ainsworth, FRCP; Frank A. Post, PhD, FCP(SA); Mark Wansbrough-Jones, FRCP; Peter Kelleher, PhD, MRCPath; for the Hydroxychloroquine Trial Team JAMA. 2012;308(4):353-361. doi:10.1001/jama.2012.6936 Effects of hydroxychloroquine on immune activation in ART- naïve patients: a 48-week randomised, double-blind, placebo-controlled trial N Paton for the Hydroxychloroquine Trial Team 6th International AIDS Society Conference, July 2011 - Rome, Italy: Poster presentation: MOPE269 14th Annual conference of the British HIV Association (BHIVA) Belfast July 2008 MRC CTU oral session research to establish optimal long-term treatment strategies HIV treatment Bulletin Volume 9 Number 5/6 May /June 2008 Can hydroxychloroquine decrease immune activation in asymptomatic patients. The African Eye voice May 2009-July 2009 Immune Activation: the other side of HIV Laura Waters Plus/ve/ your health your choice Vol 79 September 2008 Immune Activation: the other side of HIV Laura Waters UK Advisory Board Meeting (UK-CAB) Study presented for discussion at summer 2008 meeting |
| Start Year | 2008 |
| Description | INSIGHT |
| Organisation | University of Copenhagen |
| Department | Copenhagen HIV Programme (CHIP) |
| Country | Denmark |
| Sector | Academic/University |
| PI Contribution | The MRC Clinical Trials Unit acts as one of the 4 international coordinating centres for this network. Unit senior scientists sit on the Executive Steering Committee, Scientific Steering Committee, Operational Sterring Committee and co-chair the START trial. The Network is active in HIV research ( the START study) and continues to recruit to the influenza studies ( FLU002, FLU003 and FLU004) and we coordinate these studies in the countires within our region. |
| Collaborator Contribution | The Copenhagen HIV programme, Kirby institute, sydney and the group in Washington DC are the three remaining international coordinating centres within the Network. Each partner inputs into the various network governamce committees and coordinates the studies within their region. |
| Impact | The SMART, ESPRIT, SILCAAT, STALWART and START trials. Numerous publications which have been entered in section 2. |
| Start Year | 2006 |
| Description | INSIGHT |
| Organisation | University of Minnesota |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | The MRC Clinical Trials Unit acts as one of the 4 international coordinating centres for this network. Unit senior scientists sit on the Executive Steering Committee, Scientific Steering Committee, Operational Sterring Committee and co-chair the START trial. The Network is active in HIV research ( the START study) and continues to recruit to the influenza studies ( FLU002, FLU003 and FLU004) and we coordinate these studies in the countires within our region. |
| Collaborator Contribution | The Copenhagen HIV programme, Kirby institute, sydney and the group in Washington DC are the three remaining international coordinating centres within the Network. Each partner inputs into the various network governamce committees and coordinates the studies within their region. |
| Impact | The SMART, ESPRIT, SILCAAT, STALWART and START trials. Numerous publications which have been entered in section 2. |
| Start Year | 2006 |
| Description | INSIGHT |
| Organisation | University of New South Wales |
| Department | Kirby Institute |
| Country | Australia |
| Sector | Academic/University |
| PI Contribution | The MRC Clinical Trials Unit acts as one of the 4 international coordinating centres for this network. Unit senior scientists sit on the Executive Steering Committee, Scientific Steering Committee, Operational Sterring Committee and co-chair the START trial. The Network is active in HIV research ( the START study) and continues to recruit to the influenza studies ( FLU002, FLU003 and FLU004) and we coordinate these studies in the countires within our region. |
| Collaborator Contribution | The Copenhagen HIV programme, Kirby institute, sydney and the group in Washington DC are the three remaining international coordinating centres within the Network. Each partner inputs into the various network governamce committees and coordinates the studies within their region. |
| Impact | The SMART, ESPRIT, SILCAAT, STALWART and START trials. Numerous publications which have been entered in section 2. |
| Start Year | 2006 |
| Description | INSIGHT |
| Organisation | Washington DC Va Medical Center |
| Country | United States |
| Sector | Hospitals |
| PI Contribution | The MRC Clinical Trials Unit acts as one of the 4 international coordinating centres for this network. Unit senior scientists sit on the Executive Steering Committee, Scientific Steering Committee, Operational Sterring Committee and co-chair the START trial. The Network is active in HIV research ( the START study) and continues to recruit to the influenza studies ( FLU002, FLU003 and FLU004) and we coordinate these studies in the countires within our region. |
| Collaborator Contribution | The Copenhagen HIV programme, Kirby institute, sydney and the group in Washington DC are the three remaining international coordinating centres within the Network. Each partner inputs into the various network governamce committees and coordinates the studies within their region. |
| Impact | The SMART, ESPRIT, SILCAAT, STALWART and START trials. Numerous publications which have been entered in section 2. |
| Start Year | 2006 |
| Description | INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) |
| Organisation | University of Copenhagen |
| Department | Copenhagen HIV Programme (CHIP) |
| Country | Denmark |
| Sector | Academic/University |
| PI Contribution | Partner in this International Network for Strategic Initiatives in Global HIV Trials since 2006. Since then INSIGHT's scope has broadened and now the network also conducts several influenza studies. Our mission is to define optimal strategies for the management of HIV and other infectious diseases through a global clinical research network. INSIGHT conducts studies worldwide with each of the 4 coordinating centres managing different regions around the world. involved in all trial management issues and have representation on scientific, operational and executive steering committees for the group. |
| Collaborator Contribution | see above |
| Impact | results of several clinical trials such as SMART and START and publications and presentations on observational Influenza studies FLU002, FLU003 and FLU004 |
| Start Year | 2006 |
| Description | INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) |
| Organisation | University of Minnesota |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | Partner in this International Network for Strategic Initiatives in Global HIV Trials since 2006. Since then INSIGHT's scope has broadened and now the network also conducts several influenza studies. Our mission is to define optimal strategies for the management of HIV and other infectious diseases through a global clinical research network. INSIGHT conducts studies worldwide with each of the 4 coordinating centres managing different regions around the world. involved in all trial management issues and have representation on scientific, operational and executive steering committees for the group. |
| Collaborator Contribution | see above |
| Impact | results of several clinical trials such as SMART and START and publications and presentations on observational Influenza studies FLU002, FLU003 and FLU004 |
| Start Year | 2006 |
| Description | INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) |
| Organisation | University of New South Wales |
| Country | Australia |
| Sector | Academic/University |
| PI Contribution | Partner in this International Network for Strategic Initiatives in Global HIV Trials since 2006. Since then INSIGHT's scope has broadened and now the network also conducts several influenza studies. Our mission is to define optimal strategies for the management of HIV and other infectious diseases through a global clinical research network. INSIGHT conducts studies worldwide with each of the 4 coordinating centres managing different regions around the world. involved in all trial management issues and have representation on scientific, operational and executive steering committees for the group. |
| Collaborator Contribution | see above |
| Impact | results of several clinical trials such as SMART and START and publications and presentations on observational Influenza studies FLU002, FLU003 and FLU004 |
| Start Year | 2006 |
| Description | INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) |
| Organisation | Washington DC Va Medical Center |
| Department | Institute for Clinical Research |
| Country | United States |
| Sector | Hospitals |
| PI Contribution | Partner in this International Network for Strategic Initiatives in Global HIV Trials since 2006. Since then INSIGHT's scope has broadened and now the network also conducts several influenza studies. Our mission is to define optimal strategies for the management of HIV and other infectious diseases through a global clinical research network. INSIGHT conducts studies worldwide with each of the 4 coordinating centres managing different regions around the world. involved in all trial management issues and have representation on scientific, operational and executive steering committees for the group. |
| Collaborator Contribution | see above |
| Impact | results of several clinical trials such as SMART and START and publications and presentations on observational Influenza studies FLU002, FLU003 and FLU004 |
| Start Year | 2006 |
| Description | NEAT001/ANRS 143 |
| Organisation | Amsterdam Institute for Global Health and Development (AIGHD) |
| Country | Netherlands |
| Sector | Private |
| PI Contribution | The MRC CTU is one of 4 co-ordinating CTUs and is the Statistical centre for this collaboration. Unit senior scientists are on the Trial Steering committee and provide expertise and support on all aspects to study design and analysis. The research team at CTU were active members across all the trial management groups and coordinated the trial in a number of European countries. The MRC CTU also took the lead for the Biobank/Specimen Coordination for the trial. |
| Collaborator Contribution | The 3 NEAT partners in Copenhagen, France and Amsterdam constitute the remaining CTUs involved in the coordination of the NEAT001 trial across Europe. Partners have also been working on the other areas of the network outside of the clinical trial such as education and translation work. |
| Impact | The first trial NEAT 001 commenced in September 2010 and recruitment of the target of 800 patients was achieved in October 2011. Follow-up was completed in September 2013, primary results were presented at the international conference on Retroviruses and Opportunistic Infections (CROI) in March 2014 and the main paper published in the Lancet in August 2014. A number of secondary analyses and substudies are being undertaken. |
| Start Year | 2006 |
| Description | NEAT001/ANRS 143 |
| Organisation | National Institute of Health |
| Country | Italy |
| Sector | Public |
| PI Contribution | The MRC CTU is one of 4 co-ordinating CTUs and is the Statistical centre for this collaboration. Unit senior scientists are on the Trial Steering committee and provide expertise and support on all aspects to study design and analysis. The research team at CTU were active members across all the trial management groups and coordinated the trial in a number of European countries. The MRC CTU also took the lead for the Biobank/Specimen Coordination for the trial. |
| Collaborator Contribution | The 3 NEAT partners in Copenhagen, France and Amsterdam constitute the remaining CTUs involved in the coordination of the NEAT001 trial across Europe. Partners have also been working on the other areas of the network outside of the clinical trial such as education and translation work. |
| Impact | The first trial NEAT 001 commenced in September 2010 and recruitment of the target of 800 patients was achieved in October 2011. Follow-up was completed in September 2013, primary results were presented at the international conference on Retroviruses and Opportunistic Infections (CROI) in March 2014 and the main paper published in the Lancet in August 2014. A number of secondary analyses and substudies are being undertaken. |
| Start Year | 2006 |
| Description | NEAT001/ANRS 143 |
| Organisation | University of Bordeaux |
| Country | France |
| Sector | Academic/University |
| PI Contribution | The MRC CTU is one of 4 co-ordinating CTUs and is the Statistical centre for this collaboration. Unit senior scientists are on the Trial Steering committee and provide expertise and support on all aspects to study design and analysis. The research team at CTU were active members across all the trial management groups and coordinated the trial in a number of European countries. The MRC CTU also took the lead for the Biobank/Specimen Coordination for the trial. |
| Collaborator Contribution | The 3 NEAT partners in Copenhagen, France and Amsterdam constitute the remaining CTUs involved in the coordination of the NEAT001 trial across Europe. Partners have also been working on the other areas of the network outside of the clinical trial such as education and translation work. |
| Impact | The first trial NEAT 001 commenced in September 2010 and recruitment of the target of 800 patients was achieved in October 2011. Follow-up was completed in September 2013, primary results were presented at the international conference on Retroviruses and Opportunistic Infections (CROI) in March 2014 and the main paper published in the Lancet in August 2014. A number of secondary analyses and substudies are being undertaken. |
| Start Year | 2006 |
| Description | NEAT001/ANRS 143 |
| Organisation | University of Copenhagen |
| Department | Copenhagen HIV Programme (CHIP) |
| Country | Denmark |
| Sector | Academic/University |
| PI Contribution | The MRC CTU is one of 4 co-ordinating CTUs and is the Statistical centre for this collaboration. Unit senior scientists are on the Trial Steering committee and provide expertise and support on all aspects to study design and analysis. The research team at CTU were active members across all the trial management groups and coordinated the trial in a number of European countries. The MRC CTU also took the lead for the Biobank/Specimen Coordination for the trial. |
| Collaborator Contribution | The 3 NEAT partners in Copenhagen, France and Amsterdam constitute the remaining CTUs involved in the coordination of the NEAT001 trial across Europe. Partners have also been working on the other areas of the network outside of the clinical trial such as education and translation work. |
| Impact | The first trial NEAT 001 commenced in September 2010 and recruitment of the target of 800 patients was achieved in October 2011. Follow-up was completed in September 2013, primary results were presented at the international conference on Retroviruses and Opportunistic Infections (CROI) in March 2014 and the main paper published in the Lancet in August 2014. A number of secondary analyses and substudies are being undertaken. |
| Start Year | 2006 |
| Description | PIVOT |
| Organisation | African Eye Trust |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | PIVOT is the largest RCT on HIV treatment ever performed in the UK which recruited 587 patients from a network of 43 sites across the country. This network includes not only large HIV clinics linked to academic institutions traditionally involved on clinical research but also smaller centres with little experience on clinical research. The PIVOT network covers most of England (and a centre in Scotland), and therefore its study population is more diverse than in most HIV trials. The PIVOT trial has offered an important opportunity for building capacity and training to sites not previously involved in clinical research at this scale. This has been facilitated by the financial support centres have received from their comprehensive local research networks (CLRN) as PIVOT was one of the first studies adopted into the NIHR Clinical Research Network Portfolio. |
| Collaborator Contribution | Community organisations have been involved in PIVOT from the beginning, contributing not only with protocol development and implementation but also promoting the study on community media and offering possible participants information about the strategy being tested. Positive involvement of advocacy groups definitively helped the study to reach diverse communities affected by HIV to make the represented in the study population. The African Eye Trust, an NGO which supports African Communities affected by HIV in the UK was extremely important in introducing the study and offering impartial information about PI monotherapy to their target population. In addition the UK-CAB, a national network for community HIV treatment advocates, is also involved in PIVOT with direct representation in both the Trial Steering and the Independent Data Monitoring Committees. |
| Impact | Main findings were presented at the Conference On Retroviruses And Opportunistic Infections (CROI) 2014. |
| Start Year | 2008 |
| Description | PIVOT |
| Organisation | UK Community Advisory Board UKCAB |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | PIVOT is the largest RCT on HIV treatment ever performed in the UK which recruited 587 patients from a network of 43 sites across the country. This network includes not only large HIV clinics linked to academic institutions traditionally involved on clinical research but also smaller centres with little experience on clinical research. The PIVOT network covers most of England (and a centre in Scotland), and therefore its study population is more diverse than in most HIV trials. The PIVOT trial has offered an important opportunity for building capacity and training to sites not previously involved in clinical research at this scale. This has been facilitated by the financial support centres have received from their comprehensive local research networks (CLRN) as PIVOT was one of the first studies adopted into the NIHR Clinical Research Network Portfolio. |
| Collaborator Contribution | Community organisations have been involved in PIVOT from the beginning, contributing not only with protocol development and implementation but also promoting the study on community media and offering possible participants information about the strategy being tested. Positive involvement of advocacy groups definitively helped the study to reach diverse communities affected by HIV to make the represented in the study population. The African Eye Trust, an NGO which supports African Communities affected by HIV in the UK was extremely important in introducing the study and offering impartial information about PI monotherapy to their target population. In addition the UK-CAB, a national network for community HIV treatment advocates, is also involved in PIVOT with direct representation in both the Trial Steering and the Independent Data Monitoring Committees. |
| Impact | Main findings were presented at the Conference On Retroviruses And Opportunistic Infections (CROI) 2014. |
| Start Year | 2008 |
| Description | SPARTAC |
| Organisation | Imperial College London |
| Department | Faculty of Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Design, management and analysis of SPARTAC a multicentre randomised controlled trial |
| Collaborator Contribution | ICSTM: Clinical oversight, finance, coordination of oversight committees and virology University of New South Wales: Coordination of the trial in Australian sites MRC Uganda:Coordination of the trial in Ugandan sites University of Oxford: Immunology |
| Impact | Trial completed and main manuscript published in the New England Journal of Medicine in Jan 2013 and a several of secondary publications in 2014 added to section 2 |
| Start Year | 2006 |
| Description | SPARTAC |
| Organisation | MRC/UVRI Uganda Research Unit on AIDS |
| Country | Uganda |
| Sector | Public |
| PI Contribution | Design, management and analysis of SPARTAC a multicentre randomised controlled trial |
| Collaborator Contribution | ICSTM: Clinical oversight, finance, coordination of oversight committees and virology University of New South Wales: Coordination of the trial in Australian sites MRC Uganda:Coordination of the trial in Ugandan sites University of Oxford: Immunology |
| Impact | Trial completed and main manuscript published in the New England Journal of Medicine in Jan 2013 and a several of secondary publications in 2014 added to section 2 |
| Start Year | 2006 |
| Description | SPARTAC |
| Organisation | University of New South Wales |
| Department | Kirby Institute |
| Country | Australia |
| Sector | Academic/University |
| PI Contribution | Design, management and analysis of SPARTAC a multicentre randomised controlled trial |
| Collaborator Contribution | ICSTM: Clinical oversight, finance, coordination of oversight committees and virology University of New South Wales: Coordination of the trial in Australian sites MRC Uganda:Coordination of the trial in Ugandan sites University of Oxford: Immunology |
| Impact | Trial completed and main manuscript published in the New England Journal of Medicine in Jan 2013 and a several of secondary publications in 2014 added to section 2 |
| Start Year | 2006 |
| Description | SPARTAC |
| Organisation | University of Oxford |
| Department | Nuffield Department of Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Design, management and analysis of SPARTAC a multicentre randomised controlled trial |
| Collaborator Contribution | ICSTM: Clinical oversight, finance, coordination of oversight committees and virology University of New South Wales: Coordination of the trial in Australian sites MRC Uganda:Coordination of the trial in Ugandan sites University of Oxford: Immunology |
| Impact | Trial completed and main manuscript published in the New England Journal of Medicine in Jan 2013 and a several of secondary publications in 2014 added to section 2 |
| Start Year | 2006 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Barts Health NHS Trust |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Birmingham Heartlands Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | City of Coventry NHS Healthcare Centre |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Gloucestershire Royal Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Ibn Rochd University Hospital |
| Country | Morocco |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | James Cook University Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Joint Clinical Research Center, Kampala |
| Country | Uganda |
| Sector | Academic/University |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | MRC/UVRI Uganda Research Unit on AIDS |
| Country | Uganda |
| Sector | Public |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | National Institute of Health and Medical Research (INSERM) |
| Department | INSERM SC10 - US019 |
| Country | France |
| Sector | Public |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | National and Kapodistrian University of Athens |
| Country | Greece |
| Sector | Academic/University |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | North Manchester General Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Queen Elizabeth Hospital (Malaysia) |
| Country | Malaysia |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Royal Berkshire Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Royal Free Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Royal Hallamshire Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Royal Sussex County Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Royal Victoria Teaching Hospital |
| Country | Gambia |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | San Raffaele Hospital |
| Country | Italy |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Southmead Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | St Mary's Hospital, London |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | St Stephen's AIDS Trust |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | St Thomas' Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust |
| Department | Royal Bournemouth Hospital |
| Country | United Kingdom |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | University College Dublin |
| Department | School of Medicine and Medical Science |
| Country | Ireland |
| Sector | Academic/University |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | University College London |
| Department | Medical School |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | University Hospital of Bern |
| Country | Switzerland |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | University of Birmingham |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | University of Copenhagen |
| Department | Copenhagen HIV Programme (CHIP) |
| Country | Denmark |
| Sector | Academic/University |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | University of Minnesota |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | University of New South Wales |
| Country | Australia |
| Sector | Academic/University |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |
| Description | Strategic Timing of AntiRetroviral Treatment (START) Study |
| Organisation | Washington DC Va Medical Center |
| Department | Institute for Clinical Research |
| Country | United States |
| Sector | Hospitals |
| PI Contribution | Trial management, safety reporting, monitoring etc in the sites with in the UK, Ireland, Uganda, Morocco, Greece, Italy , France and Switzerland participate in the protocol team, quality management groups and substudy teams across the study and lead at CTU is co-chair for the study. |
| Collaborator Contribution | Sponsor- University of Minnesota three other international coordination groups which manage the study in the other countries of the world University of New South Wales Copenhagen HIV Programme (CHIP) The Institute for Clinical Research at the Veterans Affairs Medical Center work with University of Athens, INSERM SC10 and University of Bern to oversee management of sites in Greece, France and Switzerland and directly with the other 26 participating sites form UK , Ireland, Morocco, Italy and Uganda work with University of Athens, SC10 and University of Bern to coordinate participating clinical sites in Greece, France and Switzerland XX clinical sites , 20 in UK , 1 in Ireland , 1 in Morocco and 2 in Uganda |
| Impact | publications presentations |
| Start Year | 2009 |