Strategic Timing of Antiretroviral Treatment
START
Strategic Timing of AntiRetroviral Treatment
3 other identifiers
interventional
4,688
34 countries
215
Brief Summary
Objectives:
- To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.
- To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2009
Longer than P75 for phase_4
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2009
CompletedFirst Posted
Study publicly available on registry
March 23, 2009
CompletedStudy Start
First participant enrolled
April 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2022
CompletedResults Posted
Study results publicly available
December 20, 2023
CompletedMarch 4, 2024
February 1, 2024
13.3 years
March 20, 2009
July 19, 2023
February 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality
full follow-up, 9.3 years
Secondary Outcomes (13)
AIDs or AIDs Related Death
full follow-up, 9.3 years
Specific Non-AIDS Diagnoses
full follow-up, 9.3 years
Death, All-cause Mortality
full follow-up, 9.3 years
Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health
4.5 years
Transmission Risk Behavior Outcome 1
12 months
- +8 more secondary outcomes
Study Arms (2)
Early ART
EXPERIMENTALInitiate ART immediately following randomization
Deferred ART
ACTIVE COMPARATORDefer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops
Interventions
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Eligibility Criteria
You may qualify if:
- Signed informed consent
- HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed\* ELISA test; and confirmed by another test using a different method including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
- Age greater than or equal to 18 years
- Karnofsky performance score greater than or equal to 80 (an indication that the participant can perform normal activities)
- Perceived life expectancy of at least 6 months
- For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed
- Two CD4+ cell counts greater than 500 cells/mm(3) at least 2 weeks apart within 60 days before randomization
- The term licensed refers to an FDA-approved kit or, for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country. Confirmation of the initial test result must use a test method that is different than the one used for the initial assessment.
You may not qualify if:
- Any previous use of ART or interleukin-2 (IL-2)
- Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection)
- Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever
- Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization
- Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization
- Dialysis within 6 months before randomization
- Diagnosis of decompensated liver disease before randomization
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness
- Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmarkcollaborator
- Medical Research Councilcollaborator
- Kirby Institutecollaborator
- Washington D.C. Veterans Affairs Medical Centercollaborator
- ANRS, Emerging Infectious Diseasescollaborator
- German Federal Ministry of Education and Researchcollaborator
- NEAT - European AIDS Treatment Networkcollaborator
- National Health and Medical Research Council, Australiacollaborator
- National Institutes of Health Clinical Center (CC)collaborator
- National Cancer Institute (NCI)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- National Institute of Mental Health (NIMH)collaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)collaborator
- Abbottcollaborator
- Bristol-Myers Squibbcollaborator
- Gilead Sciencescollaborator
- GlaxoSmithKlinecollaborator
- Merck Sharp & Dohme LLCcollaborator
- Tibotec Pharmaceutical Limitedcollaborator
Study Sites (218)
University of Southern California
Alhambra, California, 91803, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
UCLA CARE-4-Families (LABAC CRS)
Los Angeles, California, 90095, United States
UCSD Mother-Child-Adolescent Program
San Diego, California, 92103, United States
Naval Medical Center San Diego
San Diego, California, 92134-1201, United States
Denver Public Health
Denver, Colorado, 80204, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422, United States
University of Florida Health Services Center
Jacksonville, Florida, 32209, United States
University of Florida, Jacksonville
Jacksonville, Florida, 32209, United States
University of Miami
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Florida Department of Health in Orange County/Sunshine Care Center
Orlando, Florida, 32805, United States
Infectious Diseases Associates NW FL, PA
Pensacola, Florida, 32503, United States
Hillsborough County Health Deptment/University of South Florida
Tampa, Florida, 33602, United States
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, 32960, United States
Mt. Sinai Hospital
Chicago, Illinois, 60608, United States
Lurie Children's Hospital
Chicago, Illinois, 60611-2605, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Community Research Initiative of New England
Boston, Massachusetts, 02111, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Newland Immunology Center of Excellence (NICE)
Southfield, Michigan, 48075, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
New Jersey Medical School Adult Clinical Research Center
Newark, New Jersey, 07103, United States
Cornell CRS
New York, New York, 10010, United States
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
UNC AIDS Clinical Trials Unit
Chapel Hill, North Carolina, 27514, United States
Duke University
Durham, North Carolina, 27710, United States
Regional Center for Infectious Disease
Greensboro, North Carolina, 27401-1209, United States
Wake County Human Services
Raleigh, North Carolina, 27610, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157-1042, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
The Research + Education Group - Portland
Portland, Oregon, 97210, United States
The Research and Education Group at Portland VA Research Foundation
Portland, Oregon, 97239, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-3678, United States
UT Southwestern Clinical Research Unit
Dallas, Texas, 75235, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107, United States
Houston AIDS Research Team
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
San Antonio Military Health System
San Antonio, Texas, 78234, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
AIDS Resource Center of Wisconsin
Milwaukee, Wisconsin, 53203, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Buenos Aires, Argentina
Hospital Interzonal General de Agudos Dr. Diego Paroissien
Isidro Casanova, Buenos Aires, Argentina
CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)
Rosario, Santa Fe Province, Argentina
FUNCEI
Buenos Aires, Argentina
Fundacion IDEAA
Buenos Aires, Argentina
Hospital General de Agudos JM Ramos Mejia
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Rawson
Córdoba, Argentina
CEIN
Neuquén, Argentina
Burwood Road General Practice
Burwood, New South Wales, 2134, Australia
East Sydney Doctors
Darlinghurst, New South Wales, 2010, Australia
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Taylor Square Private Clinic
Darlinghurst, New South Wales, 2010, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sexual Health and HIV Service - Clinic 2
Brisbane, Queensland, 4000, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053, Australia
Prahran Market Clinic
Melbourne, Victoria, 3181, Australia
Centre Clinic
St Kilda, Victoria, 3182, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Otto-Wagner-Spital SMZ /Baumgartner Hoehe
Vienna, Austria
University Vienna General Hospital
Vienna, Austria
Institute of Tropical Medicine
Antwerp, Belgium
Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)
Brussels, Belgium
Universitaire Ziekenhuizen Gent
Ghent, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium
Center for Infectious Diseases at the UFES
Vitória, Espírito Santo, 29040-091, Brazil
SEI - Servi�os Especializados em Infectologia
Salvador, Estado de Bahia, 40110-010, Brazil
Hospital Escola Sao Francisco de Assis - UFRJ
Rio de Janeiro, Rio de Janeiro, 20210-030, Brazil
Ipec/Fiocruz
Rio de Janeiro, Rio de Janeiro, 21040-900, Brazil
Instituto de Infectologia Emilio Ribas - IIER
São Paulo, São Paulo, 01246-900, Brazil
Centro de Referencia e Treinamento DST/Aids
São Paulo, São Paulo, 04121-000, Brazil
Lim 56/Hcfmusp
São Paulo, São Paulo, 05403-000, Brazil
Fundacion Arriaran
Santiago, Chile
University Hospital Plzen, CZ
Pilsen, Czechia
Faculty Hospital Na Bulovce, Prague, Czech Rep.
Prague, Czechia
Arhus Universitetshospital, Skejby
Aarhus, Denmark
Rigshospitalet, Infektionsmedicinsk ambulatorium 8622
Copenhagen, Denmark
Hvidovre University Hospital, Department of Infectious Diseases
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
West Tallinn Central Hospital Infectious Diseases
Tallinn, Estonia
Helsinki University Central Hospital, Div. of Infectious Diseases CRS
Helsinki, Finland
CHU de Besan�on - H�pital Jean-Minjoz
Besançon, France
CHU C�te de Nacre
Caen, France
H�pital Antoine Becl�re
Clamart, France
H�pital Henri Mondor
Créteil, France
H�pital de Bicetre
Le Kremlin-Bicêtre, France
Groupe Hospitalier Pitie-Salpetri�re
Paris, France
H�pital Europeen Georges Pompidou
Paris, France
H�pital H�tel Dieu
Paris, France
H�pital Saint-Antoine
Paris, France
H�pital Saint-Louis
Paris, France
H�pital Foch
Suresnes, France
Centre Hospitalier - H�pital Gustave Dron
Tourcoing, France
EPIMED-Gesellschaft fur epidemiologische und klinische Forschung in der MedizinmbH
Berlin, Germany
Gemeinschaftspraxis Jessen-Jessen-Stein
Berlin, Germany
Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS
Bonn, Germany
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
Cologne, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Universitatsklinikum Dusseldorf
Düsseldorf, Germany
Universitatsklinikum Erlangen
Erlangen, Germany
Klinik fur Dermatologie, Venerologie, Allergologie
Essen, Germany
Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS
Frankfurt, Germany
ICH Study Center
Hamburg, Germany
Ifi - Studien und Projekte GmbH
Hamburg, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitatsklinikum Heidelberg
Heidelberg, Germany
Klinikum der Universitat Munchen
Munich, Germany
Universitatsklinikum Regensburg
Regensburg, Germany
Universitatsklinikum Wurzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Infektiologie CRS
Würzburg, Germany
Attikon University General Hospital
Athens, Greece
Evangelismos General Hospital
Athens, Greece
Hippokration University General Hospital of Athens
Athens, Greece
Korgialenio-Benakio Hellenic Red Cross
Athens, Greece
Syngros Hospital
Athens, Greece
AHEPA University Hospital
Thessaloniki, Greece
Institute of Infectious Diseases
Pune, Maharashtra, 411037, India
YRGCARE Medical Centre VHS, Chennai CRS
Chennai, Tamil Nadu, 600113, India
Mater Misericordiae University Hospital
Dublin, Ireland
Rambam Medical Center
Haifa, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Ospedale San Raffaele S.r.l.
Milan, MI, Italy
Lazzaro Spallanzani IRCSS
Rome, RM, Italy
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Serefo/Cesac Mali
Bamako, Mali
INCMNSZ (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran)
Tlalpan, Mexico
University Hospital Centre Ibn Rochd
Casablanca, 20360, Morocco
Institute of Human Virology-Nigeria (IHVN)
Abuja, Federal Capital Territory, Nigeria
Oslo University Hospital, Ulleval
Oslo, Norway
Via Libre
Lima, 01, Peru
Asociacion Civil IMPACTA Salud y Educacion
Lima, 04, Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, 11, Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, 13, Peru
Asociacion Civil Impacta Salud y Educacion - Sede San Miguel
Lima, 32, Peru
Uniwersytecki Szpital Kliniczny
Bialystok, Poland
Wojewodzki Szpital Zakazny
Warsaw, Poland
EMC Instytut Medyczny SA
Wroclaw, Poland
Hospital Curry Cabral
Lisbon, Portugal
Hospital de Egas Moniz
Lisbon, Portugal
Hospital de Santa Maria
Lisbon, Portugal
Hospital Joaquim Urbano
Porto, Portugal
San Juan Hospital
Rio Piedras, 00935, Puerto Rico
University of Puerto Rico Pediatric Research Site
San Juan, 00935-6528, Puerto Rico
Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU)
San Juan, 00935, Puerto Rico
Desmond Tutu HIV Foundation Clinical Trials Unit
Cape Town, South Africa
Durban International Clinical Research Site (WWH)
Durban, South Africa
Durban International Clinical Research Site
Durban, South Africa
CHRU
Johannesburg, South Africa
1 Military Hospital
Pretoria, South Africa
Hospital Universitario Principe de Asturias
Alcalá de Henares, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS
Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Spain
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Complejo Hospitalario Xeral Cies
Vigo, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Skane University Hospital
Malmo, Sweden
University Hospital Basel
Basel, Switzerland
Bern University Hospital
Bern, Switzerland
Unite VIH/SIDA Geneva
Geneva, Switzerland
University Hospital Zurich
Zurich, Switzerland
Chulalongkorn University Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok Noi, 10700, Thailand
Sanpatong Hospital
Chiang Mai, 50120, Thailand
Research Institute for Health Sciences (RIHES)
Chiang Mai, 50200, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, 57000, Thailand
Chonburi Regional Hospital
Chon Buri, 20000, Thailand
Khon Kaen University, Srinagarind Hospital
Khon Kaen, 40002, Thailand
Bamrasnaradura Institute
Nonthaburi, 11000, Thailand
MRC/UVRI Research Unit on AIDS
Entebbe, Uganda
Joint Clinical Research Center (JCRC)
Kampala, Uganda
Royal Berkshire Hospital
Reading, Berkshire, RG1 5LE, United Kingdom
The James Cook University Hospital
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN2 1ES, United Kingdom
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW, United Kingdom
Belfast Health and Social Care Trust (RVH)
Belfast, Northern Ireland, BT12 6BA, United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2WB, United Kingdom
Birmingham Heartlands Hospital
Birmingham, West Midlands, B9 5SS, United Kingdom
Coventry and Warwickshire NHS partnership Trust
Coventry, West Midlands, CV1 4FS, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
Barts Health NHS Trust
London, E1 1BB, United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
Guy's and St.Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Lewisham and Greenwich NHS Trust
London, SE18 4QH, United Kingdom
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
St. George's Healthcare NHS Trust
London, SW17 0QT, United Kingdom
Imperial College Healthcare NHS Trust
London, W2 1NY, United Kingdom
University College London Medical School
London, WC1E 6JB, United Kingdom
North Manchester General Hospital
Manchester, M8 5RB, United Kingdom
Related Publications (33)
Babiker AG, Emery S, Fatkenheuer G, Gordin FM, Grund B, Lundgren JD, Neaton JD, Pett SL, Phillips A, Touloumi G, Vjechaj MJ; INSIGHT START Study Group. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study. Clin Trials. 2013;10(1 Suppl):S5-S36. doi: 10.1177/1740774512440342. Epub 2012 Apr 30.
PMID: 22547421BACKGROUNDINSIGHT START Study Group; Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.
PMID: 26192873RESULTMacDonald DM, Samorodnitsky S, Wendt CH, Baker JV, Collins G, Kruk M, Lock EF, Paredes R, Poongulali S, Weise DO, Winston A, Wood R, Kunisaki KM; INSIGHT START Pulmonary Substudy Group. Pneumoproteins and biomarkers of inflammation and coagulation do not predict rapid lung function decline in people living with HIV. Sci Rep. 2023 Mar 23;13(1):4749. doi: 10.1038/s41598-023-29739-x.
PMID: 36959289DERIVEDGabrielaite M, Bennedbaek M, Rasmussen MS, Kan V, Furrer H, Flisiak R, Losso M, Lundgren JD; INSIGHT START Study Group; Marvig RL. Deep-sequencing of viral genomes from a large and diverse cohort of treatment-naive HIV-infected persons shows associations between intrahost genetic diversity and viral load. PLoS Comput Biol. 2023 Jan 3;19(1):e1010756. doi: 10.1371/journal.pcbi.1010756. eCollection 2023 Jan.
PMID: 36595537DERIVEDGabrielaite M, Bennedbaek M, Zucco AG, Ekenberg C, Murray DD, Kan VL, Touloumi G, Vandekerckhove L, Turner D, Neaton J, Lane HC, Safo S, Arenas-Pinto A, Polizzotto MN, Gunthard HF, Lundgren JD, Marvig RL. Human Immunotypes Impose Selection on Viral Genotypes Through Viral Epitope Specificity. J Infect Dis. 2021 Dec 15;224(12):2053-2063. doi: 10.1093/infdis/jiab253.
PMID: 33974707DERIVEDGhazi L, Baker JV, Sharma S, Jain MK, Palfreeman A, Necsoi C, Murray DD, Neaton JD, Drawz PE. Role of Inflammatory Biomarkers in the Prevalence and Incidence of Hypertension Among HIV-Positive Participants in the START Trial. Am J Hypertens. 2020 Jan 1;33(1):43-52. doi: 10.1093/ajh/hpz132.
PMID: 31800000DERIVEDLampe FC, Rodger AJ, Burman W, Grulich A, Friedland G, Sadr WE, Neaton J, Corbelli GM, Emery S, Molina JM, Orkin C, Gatell J, Gerstoft J, Ruxrungtham K, Barbosa de Souza M, Phillips AN; INSIGHT START Study Group. Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison. AIDS. 2019 Dec 1;33(15):2337-2350. doi: 10.1097/QAD.0000000000002359.
PMID: 31764099DERIVEDWyman Engen N, Huppler Hullsiek K, Belloso WH, Finley E, Hudson F, Denning E, Carey C, Pearson M, Kagan J. A randomized evaluation of on-site monitoring nested in a multinational randomized trial. Clin Trials. 2020 Feb;17(1):3-14. doi: 10.1177/1740774519881616. Epub 2019 Oct 24.
PMID: 31647325DERIVEDCastillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Sharma S, Baker JV, Collins S, Mannheimer S, Pett S, Touzeau-Romer V, Polizzotto MN, Lundgren JD, Gardner EM; INSIGHT START Study Group. Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study. J Int AIDS Soc. 2019 Jun;22(6):e25297. doi: 10.1002/jia2.25297.
PMID: 31250552DERIVEDBorges AH, Neuhaus J, Sharma S, Neaton JD, Henry K, Anagnostou O, Staub T, Emery S, Lundgren JD; INSIGHT SMART; START Study Groups. The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis. J Infect Dis. 2019 Jan 7;219(2):254-263. doi: 10.1093/infdis/jiy442.
PMID: 30032171DERIVEDMolina JM, Grund B, Gordin F, Williams I, Schechter M, Losso M, Law M, Ekong E, Mwelase N, Skoutelis A, Wiselka MJ, Vandekerckhove L, Benfield T, Munroe D, Lundgren JD, Neaton JD; INSIGHT START study group. Which HIV-infected adults with high CD4 T-cell counts benefit most from immediate initiation of antiretroviral therapy? A post-hoc subgroup analysis of the START trial. Lancet HIV. 2018 Apr;5(4):e172-e180. doi: 10.1016/S2352-3018(18)30003-1. Epub 2018 Jan 16.
PMID: 29352723DERIVEDRonit A, Sharma S, Baker JV, Mngqibisa R, Delory T, Caldeira L, Ndembi N, Lundgren JD, Phillips AN; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Strategic Timing of Antiretroviral Treatment (START) Study Group. Serum Albumin as a Prognostic Marker for Serious Non-AIDS Endpoints in the Strategic Timing of Antiretroviral Treatment (START) Study. J Infect Dis. 2018 Jan 17;217(3):405-412. doi: 10.1093/infdis/jix350.
PMID: 29244111DERIVEDBaker JV, Sharma S, Achhra AC, Bernardino JI, Bogner JR, Duprez D, Emery S, Gazzard B, Gordin J, Grandits G, Phillips AN, Schwarze S, Soliman EZ, Spector SA, Tambussi G, Lundgren J; INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) START (Strategic Timing of Antiretroviral Treatment) Study Group. Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial. J Am Heart Assoc. 2017 May 22;6(5):e004987. doi: 10.1161/JAHA.116.004987.
PMID: 28533305DERIVEDGrady C, Touloumi G, Walker AS, Smolskis M, Sharma S, Babiker AG, Pantazis N, Tavel J, Florence E, Sanchez A, Hudson F, Papadopoulos A, Emanuel E, Clewett M, Munroe D, Denning E; INSIGHT START Informed Consent Substudy Group. A randomized trial comparing concise and standard consent forms in the START trial. PLoS One. 2017 Apr 26;12(4):e0172607. doi: 10.1371/journal.pone.0172607. eCollection 2017.
PMID: 28445471DERIVEDO'Connor J, Vjecha MJ, Phillips AN, Angus B, Cooper D, Grinsztejn B, Lopardo G, Das S, Wood R, Wilkin A, Klinker H, Kantipong P, Klingman KL, Jilich D, Herieka E, Denning E, Abubakar I, Gordin F, Lundgren JD; INSIGHT START study group. Effect of immediate initiation of antiretroviral therapy on risk of severe bacterial infections in HIV-positive people with CD4 cell counts of more than 500 cells per muL: secondary outcome results from a randomised controlled trial. Lancet HIV. 2017 Mar;4(3):e105-e112. doi: 10.1016/S2352-3018(16)30216-8. Epub 2017 Jan 5.
PMID: 28063815DERIVEDLarson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.
PMID: 26908541DERIVEDCarr A, Grund B, Neuhaus J, Schwartz A, Bernardino JI, White D, Badel-Faesen S, Avihingsanon A, Ensrud K, Hoy J; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Prevalence of and risk factors for low bone mineral density in untreated HIV infection: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):137-46. doi: 10.1111/hiv.12242.
PMID: 25711332DERIVEDMatthews GV, Neuhaus J, Bhagani S, Mehta SH, Vlahakis E, Doroana M, Naggie S, Arenas-Pinto A, Peters L, Rockstroh JK; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Baseline prevalence and predictors of liver fibrosis among HIV-positive individuals: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(Suppl 1):129-36. doi: 10.1111/hiv.12241.
PMID: 25711331DERIVEDKunisaki KM, Niewoehner DE, Collins G, Nixon DE, Tedaldi E, Akolo C, Kityo C, Klinker H, La Rosa A, Connett JE; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Pulmonary function in an international sample of HIV-positive, treatment-naive adults with CD4 counts > 500 cells/muL: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 0):119-28. doi: 10.1111/hiv.12240.
PMID: 25711330DERIVEDBaker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):109-18. doi: 10.1111/hiv.12239.
PMID: 25711329DERIVEDWright EJ, Grund B, Cysique LA, Robertson KR, Brew BJ, Collins G, Shlay JC, Winston A, Read TR, Price RW; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Factors associated with neurocognitive test performance at baseline: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:97-108. doi: 10.1111/hiv.12238.
PMID: 25711328DERIVEDLifson AR, Grandits GA, Gardner EM, Wolff MJ, Pulik P, Williams I, Burman WJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Quality of life assessment among HIV-positive persons entering the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):88-96. doi: 10.1111/hiv.12237.
PMID: 25711327DERIVEDBaxter JD, Dunn D, White E, Sharma S, Geretti AM, Kozal MJ, Johnson MA, Jacoby S, Llibre JM, Lundgren J; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Global HIV-1 transmitted drug resistance in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):77-87. doi: 10.1111/hiv.12236.
PMID: 25711326DERIVEDRodger AJ, Lampe FC, Grulich AE, Fisher M, Friedland G, Phanuphak N, Bogner JR, Pereira LC, Rietmeijer C, Burman W, Phillips AN; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Transmission risk behaviour at enrolment in participants in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 0):64-76. doi: 10.1111/hiv.12235.
PMID: 25711325DERIVEDAchhra AC, Mocroft A, Ross MJ, Ryom L, Lucas GM, Furrer H, Neuhaus J, Somboonwit C, Kelly M, Gatell JM, Wyatt CM; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Kidney disease in antiretroviral-naive HIV-positive adults with high CD4 counts: prevalence and predictors of kidney disease at enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):55-63. doi: 10.1111/hiv.12234.
PMID: 25711324DERIVEDSoliman EZ, Sharma S, Arasteh K, Wohl D, Achhra A, Tambussi G, O'Connor J, Stein JH, Duprez DA, Neaton JD, Phillips A; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Baseline cardiovascular risk in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 0):46-54. doi: 10.1111/hiv.12233.
PMID: 25711323DERIVEDLaw MG, Achhra A, Deeks SG, Gazzard B, Migueles SA, Novak RM, Ristola M; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Clinical and demographic factors associated with low viral load in early untreated HIV infection in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):37-45. doi: 10.1111/hiv.12232.
PMID: 25711322DERIVEDSharma S, Babiker AG, Emery S, Gordin FM, Lundgren JD, Neaton JN, Bakowska E, Schechter M, Wiselka MJ, Wolff MJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):30-6. doi: 10.1111/hiv.12231.
PMID: 25711321DERIVEDDenning E, Sharma S, Smolskis M, Touloumi G, Walker S, Babiker A, Clewett M, Emanuel E, Florence E, Papadopoulos A, Sanchez A, Tavel J, Grady C; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):24-9. doi: 10.1111/hiv.12230.
PMID: 25711320DERIVEDGrarup J, Rappoport C, Engen NW, Carey C, Hudson F, Denning E, Sharma S, Florence E, Vjecha MJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Challenges, successes and patterns of enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(Suppl Suppl 1):14-23. doi: 10.1111/hiv.12229.
PMID: 25711319DERIVEDGeffen N, Aagaard P, Corbelli GM, Meulbroek M, Peavy D, Rappoport C, Schwarze S, Collins S; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Community Advisory Board. Community perspective on the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):10-3. doi: 10.1111/hiv.12228.
PMID: 25711318DERIVEDINSIGHT Strategic Timing of AntiRetroviral Treatment (START) Study Group; Lundgren J, Babiker A, Gordin F, Emery S, Fatkenheuer G, Molina JM, Wood R, Neaton JD. Why START? Reflections that led to the conduct of this large long-term strategic HIV trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):1-9. doi: 10.1111/hiv.12227. No abstract available.
PMID: 25711317DERIVEDKunisaki KM, Quick H, Baker JV. HIV antiretroviral therapy reduces circulating surfactant protein-D levels. HIV Med. 2011 Oct;12(9):580-1. doi: 10.1111/j.1468-1293.2011.00920.x. No abstract available.
PMID: 21951596DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Birgit Grund
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
James D Neaton, PhD
University of Minnesota
- STUDY CHAIR
Abdel Babiker, PhD
Medical Research Council Clinical Trials Unit, London
- STUDY CHAIR
Jens Lundgren, MD, DMSc
Copenhagen HIV Programme
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2009
First Posted
March 23, 2009
Study Start
April 15, 2009
Primary Completion
July 27, 2022
Study Completion
July 27, 2022
Last Updated
March 4, 2024
Results First Posted
December 20, 2023
Record last verified: 2024-02