START Study Group

START Study Group
Name	START Study Group
Acronym	START
Type	Clinical trial network
Established	1990s
Field	Antiretroviral therapy, infectious diseases
Headquarters	International
Notable	Early antiretroviral initiation, randomized controlled trials

START Study Group The START Study Group was a multinational clinical research consortium that conducted randomized controlled trials and observational studies on antiretroviral therapy and infectious disease management, involving diverse partners across North America, Europe, Africa, and Asia. The consortium linked investigators from leading institutions to evaluate timing of treatment, virologic outcomes, immunologic markers, and public health implications, producing influential evidence cited by guideline committees and regulatory agencies.

Background and Formation

The consortium emerged from collaborations among investigators affiliated with National Institutes of Health, World Health Organization, Centers for Disease Control and Prevention, University of Oxford, University of California, San Francisco, Imperial College London, Johns Hopkins University, Harvard Medical School, University of Toronto, University College London, Karolinska Institutet, University of Cape Town, University of Nairobi, Mayo Clinic, University of Melbourne, University of Tokyo, McGill University, King's College London, Duke University, Columbia University, Stanford University, Yale University, Brown University, Vanderbilt University, University of Pittsburgh, University of Washington, Boston University, Cornell University, University of Edinburgh, University of Cambridge, ETH Zurich, University of Geneva, Mount Sinai Hospital, Toronto General Hospital, Scripps Research, Fred Hutchinson Cancer Center, Seattle Children's Hospital, National University of Singapore, Peking University, and Seoul National University. Funding and coordination drew on support from philanthropic foundations and governmental agencies such as Bill & Melinda Gates Foundation, Wellcome Trust, and national research councils.

Objectives and Scope

Primary objectives included evaluating the clinical benefit of immediate versus deferred antiretroviral therapy and defining risks of opportunistic infections and non-AIDS events, with secondary aims addressing viral reservoir dynamics, immune activation, and transmission risk. The scope encompassed randomized trials, cohort analyses, biomarker studies, and health-services research, aiming to inform guidelines from bodies like International AIDS Society, European AIDS Clinical Society, United States Public Health Service Commissioned Corps, British HIV Association, UNAIDS, and panels convened by the Food and Drug Administration and European Medicines Agency.

Study Design and Methodology

The group implemented multicenter randomized controlled trials with stratified randomization, intention-to-treat analyses, and prespecified subgroup assessments, integrating laboratory endpoints such as plasma viral load, CD4+ T-cell counts, and biomarkers measured at centralized laboratories including Addenbrooke's Hospital, Royal Free Hospital, Guy's and St Thomas' Hospital, Karolinska University Hospital, and Massachusetts General Hospital. Methodologic frameworks referenced statistical approaches from investigators at London School of Hygiene & Tropical Medicine, University of Bristol, Johns Hopkins Bloomberg School of Public Health, Harvard T.H. Chan School of Public Health, and incorporated data-safety monitoring guided by panels convened at Institute of Medicine meetings. Ancillary studies used nested case-control designs and translational assays developed in collaboration with Pasteur Institute, Broad Institute, Cold Spring Harbor Laboratory, European Molecular Biology Laboratory, Salk Institute, Ragon Institute, Wellcome Sanger Institute, and industry partners such as Gilead Sciences, GlaxoSmithKline, Roche, ViiV Healthcare, and AbbVie.

Key Findings and Publications

Major publications reported that immediate initiation of antiretroviral therapy led to reduced rates of AIDS-related events and serious non-AIDS morbidity compared with deferred therapy, findings cited in high-impact journals alongside guideline-changing syntheses by committees at World Health Organization, International Antiviral Society–USA, and European Centre for Disease Prevention and Control. Results were presented at major conferences including Conference on Retroviruses and Opportunistic Infections, International AIDS Conference, European AIDS Clinical Society Conference, Interscience Conference on Antimicrobial Agents and Chemotherapy, and IDWeek. Influential papers acknowledged contributions from investigators at University of California, Los Angeles, Northwestern University, Johns Hopkins University School of Medicine, St. Michael's Hospital (Toronto), Toronto General Hospital Research Institute, National Institute for Health and Care Research, Canadian Institutes of Health Research, Australian National Health and Medical Research Council, and RIKEN.

Impact and Influence on Clinical Practice

Evidence from the consortium informed changes in treatment initiation recommendations by organizations such as World Health Organization, International AIDS Society, British HIV Association, United States Centers for Disease Control and Prevention, and national ministries of health including Ministry of Health (United Kingdom), United States Department of Health and Human Services, Health Canada, Australian Government Department of Health, Ministry of Health, Labour and Welfare (Japan), and accelerated policy adoption in settings supported by President's Emergency Plan for AIDS Relief and Global Fund to Fight AIDS, Tuberculosis and Malaria. The work influenced antiretroviral formularies, reimbursement decisions by agencies like National Institute for Health and Care Excellence, and informed implementation studies at Médecins Sans Frontières, Clinton Health Access Initiative, Partners In Health, and World Bank-supported programs.

Members and Collaborating Institutions

Consortium membership encompassed clinicians, epidemiologists, immunologists, and statisticians affiliated with academic centers and public-health institutes including National Institutes of Health Clinical Center, Centers for Disease Control and Prevention (CDC), World Health Organization (WHO), University of Oxford, Harvard Medical School, Johns Hopkins University, Imperial College London, University of Cape Town, University of Nairobi, University of Toronto, Karolinska Institutet, University of Melbourne, McGill University, University College London, Yale University, Stanford University School of Medicine, University of California, San Francisco, University of Washington School of Medicine, Duke University School of Medicine, Massachusetts General Hospital, Scripps Research Institute, Pasteur Institute, Wellcome Trust, Bill & Melinda Gates Foundation, Gilead Sciences, ViiV Healthcare, GlaxoSmithKline, Roche, AbbVie, and regional research networks in sub-Saharan Africa, Southeast Asia, Eastern Europe, and Latin America.

Category:Clinical trials