Paediatric and adolescent infections

Lead Research Organisation: University College London

Abstract

Infections are a very important reason why children get sick. In many parts of the world, large numbers of children still die from infectious diseases, like HIV, tuberculosis, malaria and blood infections. This programme of research uses different kinds of studies to answer questions about how we can best manage and treat infections in children and young people, both to reduce their chance of dying and being sick for longer, but also to increase their quality of life. This includes studies to work out what are the best drugs to use, thinking not just about controlling infections like HIV or curing infections like tuberculosis, but also what side-effects the drugs might have or how easy or hard families find it to take different numbers and types of pills every day. Other studies are working out what aspects of living with a long-term infection like HIV have the biggest impact on children and young people’s lives, including how they manage school and friends. The goal is to provide evidence so that national and international guidelines for managing children and young people with infections recommend the best options for them.

Technical Summary

This integrated programme of complementary randomised trials, cohorts and pharmacovigilance studies aims to address questions about medicines and other interventions relevant to the most frequent and serious infectious diseases affecting children worldwide, in particular HIV, tuberculosis, malaria and sepsis. This is important because infectious diseases still dominate as causes of childhood mortality and morbidity and disproportionately affect children in sub-Saharan Africa. The programme has a large international component in Europe, North and South America, Thailand and Africa, and is at the forefront of both national and international research in paediatric infectious diseases.
The most appropriate research study designs are used for each specific question, not repeating all studies done in adults but using research in adults to identify where questions may be different or likely have different answers in children. Recognising the relative paucity of research in children, multiple complementary questions are addressed in factorial trials wherever possible to increase the evidence base for clinical management, and add value to the original investment in setting up and running the trial. Substudies investigating aspects such as pharmacokinetics, immunology, virology, and adherence are also included alongside trials wherever possible, as are additional analyses of trial data in an observational framework. High quality additional long-term data can also be collected in trial extensions by linking to cohorts. However, not all questions regarding the optimal management and treatment of HIV-infected children can be answered by randomised trials, because many cannot be framed as an implementable intervention. Data from cohort studies are used to answer these population-level questions of major relevance to children, adolescents and their families.
Our future plans are
• to continue to address clinically relevant questions in paediatric infectious diseases through appropriate research designs, and
• to ensure that results are incorporated into national and international management guidelines and policy, and then into clinical practice, including through additional operational research if relevant.
Several randomised trials in HIV and tuberculosis are funded and in advanced planning phases. Ongoing analyses within cohorts and cohort collaborations led by the group are addressing a wide range of contextual topics that can be generalised to the treatment and care of the wider population of HIV-infected children and young people. A large programme of pharmacovigilance studies continues to provide important long-term safety data to the European Medicines Agency on newly licensed antiretroviral drugs for children.

Publications

10 25 50

publication icon
Bienczak A (2016) Plasma Efavirenz Exposure, Sex, and Age Predict Virological Response in HIV-Infected African Children. in Journal of acquired immune deficiency syndromes (1999)

 
Guideline Title Guidelines for the use of antiretroviral agents in pediatric HIV infection
Description Citation in NIH paediatric HIV guidelines, 2016
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical guidelines
URL https://aidsinfo.nih.gov/guidelines/html/2/pediatric-arv-guidelines/0
 
Guideline Title WHO Guideline on Paediatric emergency triage, assessment and treatment: Care of critically ill children
Description Influence on WHO Guideline on Paediatric emergency triage, assessment and treatment: Care of critically ill children
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical guidelines
Impact The new WHO guidelines recommend that rapid fluid resuscitation is not used for children with 1 or 2 signs of shock, following the results of the FEAST trial. However, they still recommend (more conservative) fluid resuscitation for children with all three signs of shock. FEAST found that rapid fluid resuscitation was associated with excess mortality for children with any definition of shock. The new guidelines are progress, but do not completely accord with the FEAST recommendations.
URL http://apps.who.int/iris/bitstream/10665/204463/1/9789241510219_eng.pdf?ua=1
 
Description Lablite training handbook adopted by Ugandan Ministry of Health
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Member of CIPHER Steering Committee
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
 
Description Member, Paediatric/ Obstetric Subgroup of the HIV Clinical Reference Group, NHS
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
 
Description A randomized controlled trial of shorter course treatment for uncomplicated minimal childhood tuberculosis (SHINE)
Amount £3,217,996 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 10/2014 
End 10/2018
 
Description Adolescents and Adults Living with Perinatal HIV cohort (AALPHI)/ Monument Trust (Sainsbury Family)
Amount £850,000 (GBP)
Organisation The Sainsbury Family Charitable Trusts 
Department Monument Trust
Sector Charity/Non Profit
Country United Kingdom
Start 08/2011 
End 12/2015
 
Description CIPHER Cohort Collaborative Projects ($ 142964; 2014 - 2015)
Amount $46,842 (USD)
Organisation International AIDS Society (IAS) 
Sector Learned Society
Country Switzerland
Start 01/2016 
End 12/2018
 
Description Collaborative Award (Severe Malaria Africa - A consortium for Research and Trials (SMAART))
Amount £3,944,185 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 07/2018 
End 06/2023
 
Description Collaborative HIV Paediatric Study (CHIPS)/Department of Health
Amount £783,000 (GBP)
Organisation NHS England 
Sector Public
Country United Kingdom
Start 04/2010 
End 03/2019
 
Description Health Protection Research Unit, Blood Borne and Sexually Transmitted Infections
Amount £3,711,258 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2014 
 
Description Joint Global Health Trial Development Grant (TABS)
Amount £158,075 (GBP)
Funding ID MR/P021492/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 04/2017 
End 03/2019
 
Description MRC Training Fellowship - Felicity Fitzgerald
Amount £205,907 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 09/2013 
End 09/2016
 
Description PENTA Foundation, EPPICC grant
Amount £1,618,051 (GBP)
Organisation PENTA Foundation 
Sector Academic/University
Country France
Start 01/2016 
End 12/2020
 
Description Reduction of Early mortaLITY in HIV-infected African adults and children starting antiretroviral therapy: REALITY trial
Amount £3,986,746 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 11/2012 
End 03/2018
 
Description TB CHAMP: Tuberculosis Child Multidrug-resistant Preventive Therapy Trial
Amount £463,638 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 04/2016 
End 03/2019
 
Description ViiV: investigator sponsored study
Amount £6,614,624 (GBP)
Organisation Viiv Healthcare 
Sector Private
Country United Kingdom
Start 03/2016 
End 05/2021
 
Description Wellcome Trust Fellowship Helen Payne (Immunology substudies in CHER Trial)
Amount £314,606 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 09/2011 
End 07/2015
 
Description Wellcome Trust Fellowship Julia Kenny (CHAPAS 3 Trial & Substudies)
Amount £371,694 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 09/2012 
End 07/2016
 
Title AALPHI database 
Description The AALPHI database contains clinical, neurocognitive and psychsocial data on 300 vertically HIV-infected young people and a comparison group of 100 HIV negative controls in the UK. 
Type Of Material Database/Collection of data 
Year Produced 2014 
Provided To Others? Yes  
Impact Recruitment is in progress. This work is expected to significantly contribute to the evidence base on how to treat young people with vertical HIV in the future. 
 
Title CHIPS database 
Description Establishment of collaborative database containing clinical data on HIV-infected children in the UK/Ireland 
Type Of Material Database/Collection of data 
Provided To Others? Yes  
Impact Many publications written by us, and by collaborators, over the years - see URL below. Citations in international clinical guidelines. 
URL http://www.chipscohort.ac.uk/default.asp
 
Title CIPHER database 
Description Establishment of collaborative database containing clinical data on HIV-infected children in globally, representing all regions 
Type Of Material Database/Collection of data 
Year Produced 2016 
Provided To Others? Yes  
Impact Under development 
 
Title EPPICC database 
Description Establishment of collaborative database containing clinical data on HIV-infected children in Europe 
Type Of Material Database/Collection of data 
Year Produced 2011 
Provided To Others? Yes  
Impact Development of database has resulted in collaborative research projects and publications, both within the EPPICC (European Pregnancy and Paediatric HIV Cohort Collaboration) group, and in collaboration with other cohort collaborations, such as COHERE and EuroCoord. 
URL http://penta-id.org/hiv/eppicc-studies.html
 
Description EPPICC (European Paediatric and Pregnancy HIV Cohort Collaboration) 
Organisation University of Padova
Country Italy 
Sector Academic/University 
PI Contribution We co-lead this network of paediatric observational HIV cohorts along with the Institute for Child Health. We have co-written the strategic plan for this network for the next 5 year period and have contributed to the EuroCoord bid which has secured funding for this network for the next 5 years.
Collaborator Contribution We are leading a new collaborative project (EPPICC infants) for this network, and the network has provided us with data to make the project feasible. The network also contributes epidemiological and clinical expertise to the project.
Impact Goetghebuer T, Haelterman E, Le Chenadec J, Dollfus C, Gibb D, Judd A, et al. Effect of early antiretroviral therapy on the risk of AIDS/death in HIV-infected infants. AIDS 2009,23:597-604. European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC). Fosamprenavir use in children in the European Union. A report to the European Medicines Agency (EMA), August 2009 (and repeated August 2010). London: MRC Clinical Trials Unit. European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC). Early antiretroviral therapy in HIV-1 infected infants in Europe, 1996-2008: treatment response and duration of first line regimens. AIDS. 2011;25:2279-2287.
Start Year 2007
 
Description Eldoret, Kenya 
Organisation Moi University
Country Kenya 
Sector Academic/University 
PI Contribution MRC CTU at UCL is collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and expertise in clinical trial design, management and analysis.
Collaborator Contribution The Eldoret site are collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and recruiting and managing patients.
Impact Multidiscplinary, including clinical medicine, statistics, trial management, laboratory science and management. Multiple clinical trial grants, including EARNEST and REALITY trials. Publications reporting the results of these trials which have influenced national, regional and international guidelines.
Start Year 2010
 
Description EuroCoord 
Organisation European Commission
Country European Union (EU) 
Sector Public 
PI Contribution scientific lead in writing project proposal; major partner. running paediatric PENTA trials and coordinating EPPICC (European Pregnancy and Paediatric HIV Cohort Collaboration).
Collaborator Contribution scientific coordinator 2011-2012 (Work Package 3). data harmonisation
Impact The PENPACT-1 (PENTA 9 / PACTG 390) Study Team. First-line antiretroviral therapy initiation with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor combination and switch at higher versus low viral load in HIV-infected children: an open randomised controlled phase 2/3 trial. Lancet Infectious Diseases. April: 2011, 273-283.
Start Year 2011
 
Description Gilead 
Organisation Gilead Sciences, Inc.
Department Gilead
Country United Kingdom 
Sector Private 
PI Contribution Design and conduct of trial protocol
Collaborator Contribution Review of protocol; provision of free drug
Impact Final protocol; fpfv planned Q2 2016; clinical, virology, immunology, pharmacokinetics
Start Year 2015
 
Description Gilead Sciences 
Organisation Gilead Sciences, Inc.
Department Gilead
Country United Kingdom 
Sector Private 
PI Contribution The research team ran the trial: Gilead contributed drugs and funding for specific substudies.
Collaborator Contribution Provided drugs for the trial
Impact Gilead provided first-line drugs for the trial, without which there would have been no publications. They also provided specific funding for PMID 18444867, 18839777 and for the current PENTA 17 (SMILE) elvitegravir trial
 
Description Harvard University 
Organisation Harvard University
Country United States 
Sector Academic/University 
PI Contribution Collaboration between MRC CTU at UCL, Harvard University and University of Cape Town to be Data Center for CIPHER global cohort collaboration.
Collaborator Contribution Collaboration between MRC CTU at UCL, Harvard University and University of Cape Town to be Data Center for CIPHER global cohort collaboration.
Impact Outputs are being generated and are forthcoming.
Start Year 2014
 
Description IAS 
Organisation International AIDS Society (IAS)
Country Switzerland 
Sector Learned Society 
PI Contribution Collaboration between MRC CTU at UCL, Harvard University and University of Cape Town to be Data Center for CIPHER global cohort collaboration, hosted at IAS. Also collaboration between UCL and IAS for a global paediatric HIV pharmacovigilance study.
Collaborator Contribution Collaboration between MRC CTU at UCL, Harvard University and University of Cape Town to be Data Center for CIPHER global cohort collaboration, hosted at IAS. Also collaboration between UCL and IAS for a global paediatric HIV pharmacovigilance study.
Impact Outputs forthcoming
Start Year 2014
 
Description INSERMSC10- US019.Essais thérapeutiques et maladies infectieuses 
Organisation National Institute of Health and Medical Research (INSERM)
Department INSERM SC10 - US019
Country France 
Sector Public 
PI Contribution Collaboration on management and co-ordination of PENTA trials
Collaborator Contribution Collaboration on management and co-ordination of PENTA trials
Impact All PENTA trials
 
Description Institute of Child Health 
Organisation University College London
Department Institute of Child Health
Country United Kingdom 
Sector Academic/University 
PI Contribution Collaborators on an MRC Immunology substudy within ARROW, delegating activities as described under an agreement with ICH, and we take responsibility for the project in accordance with the provisions of the Funder; application for NIHR funding for PENTA 16 immunology substudy
Collaborator Contribution Training, laboratory capacity building, teaching on PENTA Courses in East and West Europe and across Africa; sharing supervision of PhD Wellcome Trust studentships (Prof. Nigel Klein). Working together on EuroCoord, EPPICC, PENTA and Hepatitis C activities (Dr Claire Thorne). Collaborators and grant holders on NIHR PENTA 16 main study and biomarker substudy
Impact MRC grant secured in 2010. Work ongoing with baseline data presented at international conferences. Involves collaboration, training and capacity building between clinical, laboratory and trial management personnel at Ugandan and Zimbabwean sites and MRC CTU and Institute of Child Health. Site laboratory trained in four colour Immunophenotyping, nucleic acid extraction protocols and quantitative and real time PCRs (on HIV, CMV and EBV), and ELISA assays. Further training will be done on other techniques, in year 2 of the study. Training was done by personnel from both CTU and ICH.
Start Year 2010
 
Description JCRC, Uganda 
Organisation Joint Clinical Research Center, Kampala
Country Uganda 
Sector Academic/University 
PI Contribution MRC CTU at UCL is collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and expertise in clinical trial design, management and analysis.
Collaborator Contribution JCRC are collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and recruiting and managing patients as a key trial site in multiple trials over the last decade.
Impact Multidiscplinary, including clinical medicine, statistics, trial management, laboratory management. Multiple clinical trial grants, including DART, ARROW, CHAPAS-3, EARNEST and REALITY trials. Multiple publications reporting the results of these trials which have influenced national, regional and international guidelines.
 
Description Janssen Pharmaceutica 
Organisation Johnson & Johnson
Department Janssen Pharmaceutica
Country Global 
Sector Private 
PI Contribution We coordinate the EPPICC pharmacovigilance project which provides long-term safety of paediatric HIV drugs to Janssen/ European Medicines Agency.
Collaborator Contribution We coordinate the EPPICC pharmacovigilance project which provides long-term safety of paediatric HIV drugs to Janssen/ European Medicines Agency.
Impact European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord. Safety of darunavir and atazanavir in HIV-infected children in Europe and Thailand. Antiviral Therapy, in press
Start Year 2011
 
Description KEMRI, Kilifi 
Organisation Kenyan Institute for Medical Research (KEMRI)
Country Kenya 
Sector Public 
PI Contribution MRC CTU at UCL is collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and expertise in clinical trial design, management and analysis
Collaborator Contribution KEMRI are collaborating on the REALITY trial in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and recruiting and managing patients.
Impact Multidiscplinary, including clinical medicine, statistics, trial management, laboratory science and management. REALITY clinical trial grant.
Start Year 2012
 
Description MLW, Malawi 
Organisation Wellcome Trust
Department Malawi-Liverpool Wellcome Trust Clinical Research Programme
Country Malawi 
Sector Charity/Non Profit 
PI Contribution MRC CTU at UCL is collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and expertise in clinical trial design, management and analysis
Collaborator Contribution MLW are collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and recruiting and managing patients as a key trial site.
Impact Multidiscplinary, including clinical medicine, statistics, trial management, laboratory science and management. Multiple clinical trial grants, including EARNEST and REALITY trials. Publications reporting the results of these trials which have influenced national, regional and international guidelines.
Start Year 2010
 
Description Monument Trust 
Organisation The Sainsbury Family Charitable Trusts
Department Monument Trust
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution MRC CTU co-ordinates the CHAPAS-2 trial and the AALPHI study
Collaborator Contribution funding. The Monument Trust also contribute to I-Base publications which CTU staff have input in to.
Impact The Monument Trust funds the pharmacokinetic teams at 2 of the Ugandan trial centres for ARROW and CHAPAS trials. Some second-line children from ARROW are co-enroled in CHAPAS-2. AALPHI study started recruiting in Q3 2012.
Start Year 2010
 
Description National Institute of Health 
Organisation National Institutes of Health (NIH)
Country United States 
Sector Public 
PI Contribution Provide scientific input in to all aspects of desgin, analysis and write up of the CHER trial (Prof Diana Gibb and Prof Abdul Babiker). With Prof Lynne Mofenson at NIAID we have worked on PENPACT-1 trial and cohort collaborations (HPPMCS).
Collaborator Contribution We have collaborated with NIH who funded the CHER trial in South Africa through a CIPRA grant. NIH have contributed funding and collaboration on the PENPACT-1 trial
Impact Papers from the CHER trial and PENPACT-1 trial, papers from HPPMCS.
 
Description Radboud University Nijmegen Medical Centre, the Netherlands 
Organisation Radboud University Nijmegen Medical Center
Country Netherlands 
Sector Academic/University 
PI Contribution The research team at the MRC co-ordinates the ARROW, CHAPAS-1,2,3 and PENTA trials and provides scientific input and analysis of EDCTP funded VITA 1 and 2 trials.
Collaborator Contribution Long standing nesting of key pharmacokinetic studies within larger trial programmes. Contributed to several PhD studentships (all Dutch), PK data resulted in licensing of new appropriate antiretroviral formulations for children in resource limited settings.
Impact Radbound University has been involved in the analysis and writing up of the pharmacokinetics data from ARROW, PENTA 18 and the CHAPAS trials which has resulted in presentations at international conferences, peer review publications, FDA and EMA approval of drugs and Clinton Foundation and UNITAID dissemination in Africa.
Start Year 2007
 
Description SGUL 
Organisation St George's University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution design and conduct of study protocol.
Collaborator Contribution SGUL - Chief Investigator and Trial Physician; PERUKI, Universities of Oxford/Bristol /UCL ICH- design and analysis of laboratory studies; University of Southampton Health Economics
Impact Multi-disciplinary - clinical, health economics, laboratory
Start Year 2013
 
Description The London School of Hygiene and Tropical Medicine 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Department Faculty of Public Health and Policy
Country United Kingdom 
Sector Academic/University 
PI Contribution coordination and facilitation of the Young Lives substudy in the ARROW trial, qualatative substudy of PENTA 16 (UK, Uganda and US) and input in to AALPHI.
Collaborator Contribution intensive training in areas of social science adding to collaborations in the African centres (ARROW and PENTA 16). provision of a forum for young people in the ARROW trial to contribute to knowledge about living with HIV infection in Africa
Impact 3 Social Scientists trained in Africa; publications and presentations at major conferences on qualitative work in ARROW and BREATHER (PENTA 11)
Start Year 2011
 
Description UZCRC, Zimbabwe 
Organisation University of Zimbabwe
Department University of Zimbabwe Clinical Research Centre
Country Zimbabwe 
Sector Academic/University 
PI Contribution MRC CTU at UCL is collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and expertise in clinical trial design, management and analysis
Collaborator Contribution UZCRC are collaborating on trials in the treatment and management of adult, adolescent and paediatric HIV infection, providing scientific leadership and recruiting and managing patients as a key trial site in multiple trials over the last decade.
Impact Multidiscplinary, including clinical medicine, statistics, trial management, laboratory science and management. Multiple clinical trial grants, including DART, ARROW, EARNEST and REALITY trials. Multiple publications reporting the results of these trials which have influenced national, regional and international guidelines.
 
Description University of Cape Town 
Organisation University of Cape Town
Department Division of Clinical Pharmacology
Country South Africa 
Sector Academic/University 
PI Contribution MRC CTU coordinates the CHAPAS 3, PENTA 17 (SMILE) and PENTA 20 (ODYSSEY) clinical trials.
Collaborator Contribution Dr Helen McIlleron's team designed, coordinate and analyse pharmacokinetic studies in collaboration with Prof David Burger from Nimejgen. Collaboration between MRC CTU at UCL, Harvard University and University of Cape Town to be Data Center for CIPHER global cohort collaboration. Clinical site for PENTA 17 (SMILE) and PENTA 20 (ODYSSEY) clinical trials
Impact Analyses of CHAPAS 3 data are currently in progress
Start Year 2010
 
Title CAP-IT - amoxicillin 
Description Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community Acquired Pneumonia (CAP): a randomIsed controlled Trial (CAP-IT). Funded by NIHR HTA. Recruitment started Q1 2017. Collaboration with PERUKI, SGUL, Universities of Bristol, Southampton, Oxford. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Refinement. Clinical
Year Development Stage Completed 2016
Development Status Under active development/distribution
Clinical Trial? Yes
UKCRN/ISCTN Identifier HTA 13/88/11
Impact Feasibility study completed. Pilot study will include validation of saliva swabs against nasopharyngeal swabs for identification of S.pneumoniae and identification of changes in antibiotic resistance. 
 
Title Enhanced opportunistic infection prophylaxis 
Description In the REALITY trial we are testing a "bundle" of drugs as enhanced prophylaxis for 12 weeks (in addition to standard triple combination therapy) in HIV-infected adults, adolescents and older children (>5 years) with severe immunosuppression when they start anti-HIV treatment, to see if the bundle reduces early mortality on treatment. The bundle contains isoniazid (anti-tuberculosis), fluconazole (anti-cryptococcus), azithromycin (anti-bacterial infections) and albendazole (anti-helminths). 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2012
Development Status Under active development/distribution
Clinical Trial? Yes
Impact None 
 
Title ODYSSEY - PENTA 20 
Description ODYSSEY (Once daily dolutegravir in young people vs standard therapy) - A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART. FPFV due April 2016. Funding from EU, PENTA Foundation, ViiV, INSERM. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Market authorisation
Year Development Stage Completed 2015
Development Status Under active development/distribution
Clinical Trial? Yes
Impact n/a 
URL http://penta-id.org
 
Title Plumpynut 
Description Plumpynut is a nutritional supplement made from peanuts, and including specific multi-vitamins and multi-minerals. In the REALITY trial we are testing using it as adjunctive therapy for 12 weeks (in addition to standard triple combination therapy) in HIV-infected adults, adolescents and older children (>5 years) with severe immunosuppression when they start anti-HIV treatment, to see if it reduces early mortality on treatment. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2012
Development Status Under active development/distribution
Clinical Trial? Yes
Impact None. 
 
Title Raltegravir 
Description Raltegravir is an integrase inhibitor licenced for the treatment of HIV infection. In the REALITY trial we are testing using it as adjunctive therapy for 12 weeks (in addition to standard triple combination therapy) in HIV-infected adults, adolescents and older children (>5 years) with severe immunosuppression when they start anti-HIV treatment, to see if it reduces early mortality on treatment. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2012
Development Status Under active development/distribution
Clinical Trial? Yes
Impact None. 
 
Title elvitegravir 
Description A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to elvitegravir (EVG) administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2015
Development Status Under active development/distribution
Clinical Trial? Yes
Impact First patient expected Q2 2016 
URL http://www.penta-id.org
 
Description BREATHER (PENTA 16) results 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation of the results of the trial at a major scientific conference. Butler K on behalf of the BREATHER trial team: ART with weekends off is non-inferior to continuous ART in young people on EFV+2 NRTI. CROI 2015, Seattle, USA, Feb 23 -26 2015. Oral presentation abstract 38LB.
Year(s) Of Engagement Activity 2015
URL http://penta-id.org
 
Description BREATHER briefing paper 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact We produced a briefing paper on the BREATHER trial results.
Year(s) Of Engagement Activity 2016
URL http://www.ctu.mrc.ac.uk/13706/13710/breather_briefing_paper
 
Description CHIVA 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Twice yearly contribution of lay text on the CHIPS study to the CHIVA Newsletter; yearly presentation of key findings from the CHIPS and AALPHI studies at the CHIVA national conference. Updating on results and ongoing PENTA trials

Improved reporting of patients to CHIPS, and general understanding of the CHIPS data and its importance. Recruitment of patients into PENTA trials
Year(s) Of Engagement Activity 2006,2007,2008,2009,2010
 
Description Lablite training briefing paper 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact We produced a briefing paper summarising the training approach used within Lablite. This briefing paper was distributed at the International AIDS Conference in Durban.
Year(s) Of Engagement Activity 2016
 
Description London Specialised Commissioning Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Annual production of a newsletter (annual report) and slide set which presents CHIPS data in lay language. Presentation of data at twice yearly London HIV Consortium meetings

CHIPS data are now used as the basis for commissioning paediatric HIV services across England, and are being developed to measure quality of services within new designation schemes.
Year(s) Of Engagement Activity 2006,2007,2008,2009,2010
 
Description MRC Festival Workshop on Getting Results Faster for Patients 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact As part of the Medical Research Council (MRC) Festival of Medical Research, the MRC Clinical Trials Unit at University College London (MRC CTU at UCL) held a half-day workshop exploring how the Unit is working to get faster results and impact from clinical trials. We invited patient representatives involved in our studies, and patient groups who are interested in clinical trials. 30 people from 20 patient groups and various trials attended the workshop, along with around 20 members of MRC CTU at UCL staff.
Year(s) Of Engagement Activity 2016
URL http://www.ctu.mrc.ac.uk/news/2016/getting_results_faster_workshop_report_010816
 
Description Presentation of BREATHER (PENTA 16) qualitative results 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Seeley J on behalf of the Bernays S, Paparini S, Namukwaya Kihika S, Rhodes T and the BREATHER Trial Team. "But it's my story": exploring the experience and effect of telling children how they have acquired HIV; 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.
Year(s) Of Engagement Activity 2015
URL http://penta-id.org
 
Description Presentation of BREATHER and ARROW qualitative work 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Bernays S, Seeley J, Paparini S, Rhodes T and the ARROW and BREATHER trial teams 'I am scared of getting caught up in my lie': challenges to self-reported adherence for young people living with HIV; accepted for presentation at AIDS Impact, Amsterdam 28-31 July, 2015 (abstract 3435)
Year(s) Of Engagement Activity 2015
URL http://penta-id.org
 
Description Presentation of further results of BREATHER (PENTA 16) qualitative work 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Paparini S on behalf of Bernays S, Seeley S, Rhodes T, Namukwaya Kihika S,Kawuma-Kigawa R, Nakyambadde H, Kabajaasi O and the BREATHER Trial Team. Young people, clinical trials and 'the HIV experience': What can similarities across time and place tell us about growing up with HIV? 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.
Year(s) Of Engagement Activity 2015
URL http://penta-id.org
 
Description Presentation of qualitative work in BREATHER (PENTA 16 ) in the UK 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Bernays S, Seeley J, Paparini S, Rhodes T and the BREATHER trial teams 'I was like, oh my God, what happens if it doesn't work'?: young people living with HIV, clinical trial participation, and the truth economy accepted for presentation at BSA Medical Sociology Conference, York, 9-11 September 2015 (Paper ID No: W0012148).
Year(s) Of Engagement Activity 2015
URL http://penta-id.org
 
Description Stand at International AIDS Conference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact We had a stand at the International AIDS Conference in Durban, distributing outputs from our HIV studies including policy briefs, graphic novels, films and video case studies and other training materials.
Year(s) Of Engagement Activity 2016
 
Description Youth Trial Board meeting with MRC CTU 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact We held a meeting with the UK Youth Trial Board to share our research and get their feedback.
Year(s) Of Engagement Activity 2017