AzTrials
AzTrials

HIV InfectionPhase 4STARTNCT00867048

Strategic Timing of Antiretroviral Treatment

A Phase 4 study testing All licensed antiretroviral medications in people with HIV Infection, run by University of Minnesota at 218 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
All licensed antiretroviral medications
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,688 participants
Where
218 sitesin 36 countries
Study dates
15 Apr 2009to 27 Jul 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

218 sites in 36 countries.

218 sites in 36 countries

United States55 sites

  • University of Southern California

    Alhambra, California, 91803

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

  • Community Research Initiative of New England

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • UNC AIDS Clinical Trials Unit

    Chapel Hill, North Carolina, 27514

  • Mt. Sinai Hospital

    Chicago, Illinois, 60608

  • Lurie Children's Hospital

    Chicago, Illinois, 60611-2605

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • UT Southwestern Clinical Research Unit

    Dallas, Texas, 75235

  • Denver Public Health

    Denver, Colorado, 80204

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • Regional Center for Infectious Disease

    Greensboro, North Carolina, 27401-1209

  • Houston AIDS Research Team

    Houston, Texas, 77030

  • Texas Children's Hospital

    Houston, Texas, 77030

  • University of Florida Health Services Center

    Jacksonville, Florida, 32209

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • UCLA CARE-4-Families (LABAC CRS)

    Los Angeles, California, 90095

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105-3678

  • University of Miami

    Miami, Florida, 33136

  • AIDS Resource Center of Wisconsin

    Milwaukee, Wisconsin, 53203

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • Cornell CRS

    New York, New York, 10010

  • New Jersey Medical School Adult Clinical Research Center

    Newark, New Jersey, 07103

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Florida Department of Health in Orange County/Sunshine Care Center

    Orlando, Florida, 32805

  • Infectious Diseases Associates NW FL, PA

    Pensacola, Florida, 32503

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • The Research + Education Group - Portland

    Portland, Oregon, 97210

  • The Research and Education Group at Portland VA Research Foundation

    Portland, Oregon, 97239

  • Naval Medical Center Portsmouth

    Portsmouth, Virginia, 23708

  • Wake County Human Services

    Raleigh, North Carolina, 27610

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • San Antonio Military Health System

    San Antonio, Texas, 78234

  • UCSD Mother-Child-Adolescent Program

    San Diego, California, 92103

  • Naval Medical Center San Diego

    San Diego, California, 92134-1201

  • Newland Immunology Center of Excellence (NICE)

    Southfield, Michigan, 48075

  • Hillsborough County Health Deptment/University of South Florida

    Tampa, Florida, 33602

  • Bronx-Lebanon Hospital Center

    The Bronx, New York, 10457

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • AIDS Research and Treatment Center of the Treasure Coast

    Vero Beach, Florida, 32960

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Washington DC VA Medical Center

    Washington D.C., District of Columbia, 20422

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157-1042

Other trials in United States

United Kingdom21 sites

  • Belfast Health and Social Care Trust (RVH)

    Belfast, Northern Ireland, BT12 6BA

  • Queen Elizabeth Hospital Birmingham

    Birmingham, West Midlands, B15 2WB

  • Birmingham Heartlands Hospital

    Birmingham, West Midlands, B9 5SS

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, East Sussex, BN2 1ES

  • Southmead Hospital

    Bristol, BS10 5NB

  • Coventry and Warwickshire NHS partnership Trust

    Coventry, West Midlands, CV1 4FS

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

  • Leicester Royal Infirmary

    Leicester, Leicestershire, LE1 5WW

  • Barts Health NHS Trust

    London, E1 1BB

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Guy's and St.Thomas' NHS Foundation Trust

    London, SE1 7EH

  • Lewisham and Greenwich NHS Trust

    London, SE18 4QH

  • Chelsea and Westminster Hospital

    London, SW10 9NH

  • St. George's Healthcare NHS Trust

    London, SW17 0QT

  • Imperial College Healthcare NHS Trust

    London, W2 1NY

  • University College London Medical School

    London, WC1E 6JB

  • North Manchester General Hospital

    Manchester, M8 5RB

  • The James Cook University Hospital

    Middlesbrough, Cleveland, TS4 3BW

  • Royal Berkshire Hospital

    Reading, Berkshire, RG1 5LE

  • Sheffield Teaching Hospital NHS Foundation Trust

    Sheffield, South Yorkshire, S10 2JF

Other trials in United Kingdom

Germany17 sites

  • EPIMED-Gesellschaft fur epidemiologische und klinische Forschung in der MedizinmbH

    Berlin

  • Gemeinschaftspraxis Jessen-Jessen-Stein

    Berlin

  • Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS

    Bonn

  • Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV

    Cologne

  • Klinikum Dortmund gGmbH

    Dortmund

  • Universitatsklinikum Dusseldorf

    Düsseldorf

  • Universitatsklinikum Erlangen

    Erlangen

  • Klinik fur Dermatologie, Venerologie, Allergologie

    Essen

  • Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS

    Frankfurt

  • ICH Study Center

    Hamburg

  • Ifi - Studien und Projekte GmbH

    Hamburg

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Universitatsklinikum Heidelberg

    Heidelberg

  • Klinikum der Universitat Munchen

    Munich

  • Universitatsklinikum Regensburg

    Regensburg

  • Universitatsklinikum Wurzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Infektiologie CRS

    Würzburg

Other trials in Germany

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Sexual Health and HIV Service - Clinic 2

    Brisbane, Queensland, 4000

  • Burwood Road General Practice

    Burwood, New South Wales, 2134

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales, 2010

  • St. Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Taylor Square Private Clinic

    Darlinghurst, New South Wales, 2010

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Melbourne Sexual Health Centre

    Melbourne, Victoria, 3053

  • Prahran Market Clinic

    Melbourne, Victoria, 3181

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Centre Clinic

    St Kilda, Victoria, 3182

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

France12 sites

  • CHU de Besan�on - H�pital Jean-Minjoz

    Besançon

  • CHU C�te de Nacre

    Caen

  • H�pital Antoine Becl�re

    Clamart

  • H�pital Henri Mondor

    Créteil

  • H�pital de Bicetre

    Le Kremlin-Bicêtre

  • Groupe Hospitalier Pitie-Salpetri�re

    Paris

  • H�pital Europeen Georges Pompidou

    Paris

  • H�pital H�tel Dieu

    Paris

  • H�pital Saint-Antoine

    Paris

  • H�pital Saint-Louis

    Paris

  • H�pital Foch

    Suresnes

  • Centre Hospitalier - H�pital Gustave Dron

    Tourcoing

Other trials in France

Spain12 sites

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares

  • Hospital Universitari Germans Trias i Pujol

    Badalona

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Clinico San Carlos

    Madrid

  • Hospital La Paz

    Madrid

  • Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS

    Madrid

  • Hospital Universitario Doce de Octubre

    Madrid

  • Hospital Universitari Mutua Terrassa

    Terrassa

  • Hospital Universitario y Politecnico La Fe

    Valencia

  • Complejo Hospitalario Xeral Cies

    Vigo

Other trials in Spain

Argentina9 sites

  • FUNCEI

    Buenos Aires

  • Fundacion IDEAA

    Buenos Aires

  • Hospital General de Agudos JM Ramos Mejia

    Buenos Aires

  • Hospital Italiano de Buenos Aires

    Buenos Aires

  • Hospital Rawson

    Córdoba

  • Hospital Nacional Profesor Alejandro Posadas

    El Palomar, Buenos Aires

  • Hospital Interzonal General de Agudos Dr. Diego Paroissien

    Isidro Casanova, Buenos Aires

  • CEIN

    Neuquén

  • CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)

    Rosario, Santa Fe Province

Other trials in Argentina

Thailand9 sites

  • Chulalongkorn University Hospital

    Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok Noi, 10700

  • Sanpatong Hospital

    Chiang Mai, 50120

  • Research Institute for Health Sciences (RIHES)

    Chiang Mai, 50200

  • Chiangrai Prachanukroh Hospital

    Chiang Rai, 57000

  • Chonburi Regional Hospital

    Chon Buri, 20000

  • Khon Kaen University, Srinagarind Hospital

    Khon Kaen, 40002

  • Bamrasnaradura Institute

    Nonthaburi, 11000

Other trials in Thailand

Brazil7 sites

  • Hospital Escola Sao Francisco de Assis - UFRJ

    Rio de Janeiro, Rio de Janeiro, 20210-030

  • Ipec/Fiocruz

    Rio de Janeiro, Rio de Janeiro, 21040-900

  • SEI - Servi�os Especializados em Infectologia

    Salvador, Estado de Bahia, 40110-010

  • Instituto de Infectologia Emilio Ribas - IIER

    São Paulo, São Paulo, 01246-900

  • Centro de Referencia e Treinamento DST/Aids

    São Paulo, São Paulo, 04121-000

  • Lim 56/Hcfmusp

    São Paulo, São Paulo, 05403-000

  • Center for Infectious Diseases at the UFES

    Vitória, Espírito Santo, 29040-091

Other trials in Brazil

Greece6 sites

  • Attikon University General Hospital

    Athens

  • Evangelismos General Hospital

    Athens

  • Hippokration University General Hospital of Athens

    Athens

  • Korgialenio-Benakio Hellenic Red Cross

    Athens

  • Syngros Hospital

    Athens

  • AHEPA University Hospital

    Thessaloniki

Other trials in Greece

Peru5 sites

  • Via Libre

    Lima, 01

  • Asociacion Civil IMPACTA Salud y Educacion

    Lima, 04

  • Hospital Nacional Edgardo Rebagliati Martins

    Lima, 11

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima, 13

  • Asociacion Civil Impacta Salud y Educacion - Sede San Miguel

    Lima, 32

Other trials in Peru

South Africa5 sites

  • Desmond Tutu HIV Foundation Clinical Trials Unit

    Cape Town

  • Durban International Clinical Research Site (WWH)

    Durban

  • Durban International Clinical Research Site

    Durban

  • CHRU

    Johannesburg

  • 1 Military Hospital

    Pretoria

Other trials in South Africa

Belgium4 sites

  • Institute of Tropical Medicine

    Antwerp

  • Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)

    Brussels

  • Universitaire Ziekenhuizen Gent

    Ghent

  • Universitair Ziekenhuis Gasthuisberg

    Leuven

Other trials in Belgium

Denmark4 sites

  • Arhus Universitetshospital, Skejby

    Aarhus

  • Rigshospitalet, Infektionsmedicinsk ambulatorium 8622

    Copenhagen

  • Hvidovre University Hospital, Department of Infectious Diseases

    Hvidovre

  • Odense University Hospital

    Odense

Other trials in Denmark

Portugal4 sites

  • Hospital Curry Cabral

    Lisbon

  • Hospital de Egas Moniz

    Lisbon

  • Hospital de Santa Maria

    Lisbon

  • Hospital Joaquim Urbano

    Porto

Other trials in Portugal

Switzerland4 sites

  • University Hospital Basel

    Basel

  • Bern University Hospital

    Bern

  • Unite VIH/SIDA Geneva

    Geneva

  • University Hospital Zurich

    Zurich

Other trials in Switzerland

Poland3 sites

  • Uniwersytecki Szpital Kliniczny

    Bialystok

  • Wojewodzki Szpital Zakazny

    Warsaw

  • EMC Instytut Medyczny SA

    Wroclaw

Other trials in Poland

Puerto Rico3 sites

  • San Juan Hospital

    Rio Piedras, 00935

  • University of Puerto Rico Pediatric Research Site

    San Juan, 00935-6528

  • Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU)

    San Juan, 00935

Other trials in Puerto Rico

Austria2 sites

  • Otto-Wagner-Spital SMZ /Baumgartner Hoehe

    Vienna

  • University Vienna General Hospital

    Vienna

Other trials in Austria

Czechia2 sites

  • University Hospital Plzen, CZ

    Pilsen

  • Faculty Hospital Na Bulovce, Prague, Czech Rep.

    Prague

Other trials in Czechia

India2 sites

  • YRGCARE Medical Centre VHS, Chennai CRS

    Chennai, Tamil Nadu, 600113

  • Institute of Infectious Diseases

    Pune, Maharashtra, 411037

Other trials in India

Israel2 sites

  • Rambam Medical Center

    Haifa

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Italy2 sites

  • Ospedale San Raffaele S.r.l.

    Milan, MI

  • Lazzaro Spallanzani IRCSS

    Rome, RM

Other trials in Italy

Sweden2 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Skane University Hospital

    Malmö

Other trials in Sweden

Uganda2 sites

  • MRC/UVRI Research Unit on AIDS

    Entebbe

  • Joint Clinical Research Center (JCRC)

    Kampala

Other trials in Uganda

Chile1 site

  • Fundacion Arriaran

    Santiago

Other trials in Chile

Estonia1 site

  • West Tallinn Central Hospital Infectious Diseases

    Tallinn

Other trials in Estonia

Finland1 site

  • Helsinki University Central Hospital, Div. of Infectious Diseases CRS

    Helsinki

Other trials in Finland

Ireland1 site

  • Mater Misericordiae University Hospital

    Dublin

Other trials in Ireland

Luxembourg1 site

  • Centre Hospitalier de Luxembourg

    Luxembourg

Other trials in Luxembourg

Malaysia1 site

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur

Other trials in Malaysia

Mali1 site

  • Serefo/Cesac Mali

    Bamako

Other trials in Mali

Mexico1 site

  • INCMNSZ (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran)

    Tlalpan

Other trials in Mexico

Morocco1 site

  • University Hospital Centre Ibn Rochd

    Casablanca, 20360

Other trials in Morocco

Nigeria1 site

  • Institute of Human Virology-Nigeria (IHVN)

    Abuja, Federal Capital Territory

Other trials in Nigeria

Norway1 site

  • Oslo University Hospital, Ulleval

    Oslo

Other trials in Norway

About this study

Official title: Strategic Timing of AntiRetroviral Treatment

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.
Read the detailed description

Background:

  • Most guidelines agree that if the number of your CD4+ cells (cells in your blood which help fight infection) drops below 350 cells/mm3, or if you have symptoms of AIDS, you should start taking HIV medicines. There are randomized trials that support this recommendation. (Randomized trials are usually considered the strongest form of evidence to support treatment decisions. Other studies, like observational studies, provide evidence too, but the evidence is often considered to be weaker than evidence from randomized trials. A randomized trial gives the most certain information about how well a treatment works because randomization makes sure each group is similar except for the treatment they receive.) Some experts believe that HIV treatment should be started even when the number of CD4+ cells is above 350 cells/mm3. For example, guidelines issued in the US in December 2009 include a new recommendation for starting HIV medicines if your CD4+ cell count is between 350 and 500 cells/mm3. However, this recommendation is based on information from observational studies, not randomized trials. We are doing this study to find out if the chances of getting a serious illness or of getting AIDS are less if people start taking HIV medicines at a time when their CD4+ cell counts are still fairly high, instead of waiting to take HIV medicines at a CD4+ count where there is good evidence for starting medicines.

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 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.

Eligibility:

  • Patients 18 years of age and older who are infected with HIV, have CD4+ cell counts of greater than 500 cells/mm3, and who have never had antiretroviral therapy to treat HIV.

Design:

  • Initial screening visits (2) to draw blood for CD4+ cell counts and provide a full medical history
  • Patients will be randomly split into two groups:

Early: Patients will begin receiving HIV medications from the start of the study.

Deferred: Patients will begin to take HIV medications when the CD4 drops below 350 cells/mm3, or they develop AIDS or other symptoms of HIV infection.

  • HIV medications for each patient will be determined by the study doctors.
  • Evaluations during the treatment period:
  • Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
  • Questions about daily life, including sexual behaviors.
  • Blood and urine tests.
  • Heart tests with electrocardiogram.
  • Patients will return for evaluations at 1 and 4 months after randomization, and every 4 months thereafter for the duration of the study.

Substudies will take advantage of the START randomization to compare outcomes in people starting ART early vs. later.

The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm(3) in terms of morbidity and mortality in HIV-1 (subsequently referred to as HIV) infected persons who are antiretroviral naive with a CD4+ count above 500 cells/mm(3).

The study will enroll an estimated 4,000 participants. Participants will be followed for at least 3 years after enrollment, to a common closing date.

Substudies will take advantage of the START randomization to compare outcomes in people starting ART early vs. later. These will measure outcomes that do not require the entire sample size of START to determine whether early ART is related to a difference in these outcomes over the course of the study.

Conditions
HIV Infection
Being tested
All licensed antiretroviral medications
Keywords
highly active antiretroviral therapy (HAART), CD4 Count, Early Intervention, HIV, HIV Infection, HIV Infections, treatment naive
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • All licensed antiretroviral medicationsDrug

    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.

Study groups in NCT00867048
Study groupRoleWhat they receive
Early ARTExperimentalInitiate ART immediately following randomization
Receives: Drug: All licensed antiretroviral medications
Deferred ARTActive comparatorDefer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops
Receives: Drug: All licensed antiretroviral medications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality

    Measured: full follow-up, 9.3 years

Secondary outcomes (13)

  1. AIDs or AIDs Related Death

    participant count

    Measured: full follow-up, 9.3 years

  2. Specific Non-AIDS Diagnoses

    Measured: full follow-up, 9.3 years

  3. Death, All-cause Mortality

    Count of participants

    Measured: full follow-up, 9.3 years

  4. Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health

    Mean change from baseline of the VAS. This was a single data item where participants self-reported their perceived current state of health on a scale of 0-100 (0=worst possible and 100=best possible).

    Measured: 4.5 years

  5. Transmission Risk Behavior Outcome 1

    Proportion of participants identifying as men who have sex with men (MSM) engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.

    Measured: 12 months

  6. Change in Neurocognitive Function (in a Subset of Participants)

    Mean change from baseline of the QNPZ-8 score. In the Neurology substudy of START, participants were administered a neuropsychological test battery of 8 tests (grooved peg board, finger tapping, Color Trails 1 and 2, Semantic Verbal Fluency, WAIS III Digit Symbol, HVLT-R Learning, HVLT-R Delayed Recall). Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Z-scores > 0 indicate improvement over baseline levels. The quantitative neuropsychological performance z-score (QNPZ-8) was the mean of the z-scores across the the 8 tests. Analyses were by intention-to-treat principles.

    Measured: 4.5 years

  7. Large Artery Elasticity (in a Subset of Participants)

    Mean change from baseline in large arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.

    Measured: 4.5 years

  8. Rate of Lung Function Decline (in a Subset of Participants) Among

    Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.

    Measured: 4.5 years

  9. Changes in Bone Mineral Density (in a Subset of Participants) Measure 1

    Mean percent change from baseline in bone mineral density at the spine. In the bone mineral density (BMD) substudy of START, participants underwent dual-enery x-ray absorptionmetry (DXA) to measure BMD at the spine and hip at baseline and annually. Analyses were by intention-to-treat principles.

    Measured: 4.5 years

  10. Transmission Risk Behavior Outcome 2

    Percentage of participants identifying as hetrosexual engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.

    Measured: 12 month visit

  11. Small Artery Elasticity (in a Subset of Participants)

    Mean change from baseline in small arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.

    Measured: 4.5 years

  12. Rate of Lung Function Decline (in a Subset of Participants) Among Non-smokers

    Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported non-smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.

    Measured: 4.5 years

  13. Changes in Bone Mineral Density (in a Subset of Participants) Measure 2

    Mean percent change from baseline in bone mineral density at the spine. In the bone mineral density (BMD) substudy of START, participants underwent dual-enery x-ray absorptionmetry (DXA) to measure BMD at the spine and hip at baseline and annually. Analyses were by intention-to-treat principles.

    Measured: 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2009 (estimated)
  2. Study start15 Apr 2009
  3. Primary completion27 Jul 2022
  4. Study completion27 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00867048
Sponsor's protocol ID
0603M83587
Other IDs
U01AI068641, 2008-006439-12, 2008
Acronym
START
Status last verified
Feb 2024
First submitted
20 Mar 2009
Last updated
4 Mar 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22547421

  • INSIGHT 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.

    PubMed 26192873

  • Ramaswami R, Nordwall JA, Gilbert D, Kitchell E, Timiryasova A, Mitsuyasu R, Phillips AN, Lundgren J, Grabar S. Early antiretroviral therapy and long-term cancer risk in HIV: 9-year outcomes from the START randomized trial. BMC Cancer. 2026 Jun 6. doi: 10.1186/s12885-026-16188-8. Online ahead of print.

    PubMed 42251304

  • MacDonald 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.

    PubMed 36959289

  • Gabrielaite 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.

    PubMed 36595537

  • Gabrielaite 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.

    PubMed 33974707

  • Ghazi 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.

    PubMed 31800000

  • Lampe 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.

    PubMed 31764099

  • Wyman 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.

    PubMed 31647325

  • Castillo-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.

    PubMed 31250552

  • Borges 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.

    PubMed 30032171

  • Molina 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.

    PubMed 29352723

  • Ronit 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.

    PubMed 29244111

  • Baker 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.

    PubMed 28533305

  • Grady 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.

    PubMed 28445471

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing All licensed antiretroviral medications in people with HIV Infection, run by University of Minnesota at 218 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 218 sites in United States, United Kingdom, Germany, Australia, France and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality (time frame: full follow-up, 9.3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00867048, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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