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

Publications

10 25 50

 
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 European Union (EU)
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
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 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 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 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 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 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