search
Back to results

Strategic Timing of Antiretroviral Treatment (START)

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
All licensed antiretroviral medications
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring highly active antiretroviral therapy (HAART), CD4 Count, Early Intervention, HIV, HIV Infection, HIV Infections, treatment naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

  • 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.

EXCLUSION CRITERIA:

  • 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)

Sites / Locations

  • University of Southern California
  • VA Greater Los Angeles Healthcare System
  • UCLA CARE-4-Families (LABAC CRS)
  • UCSD Mother-Child-Adolescent Program
  • Naval Medical Center San Diego
  • Denver Public Health
  • Yale University School of Medicine
  • Georgetown University
  • George Washington Medical Faculty Associates
  • Washington DC VA Medical Center
  • University of Florida Health Services Center
  • University of Florida, Jacksonville
  • University of Miami
  • Orlando Immunology Center
  • Florida Department of Health in Orange County/Sunshine Care Center
  • Infectious Diseases Associates NW FL, PA
  • Hillsborough County Health Deptment/University of South Florida
  • AIDS Research and Treatment Center of the Treasure Coast
  • Mt. Sinai Hospital
  • Lurie Children's Hospital
  • University of Illinois at Chicago
  • Tulane University Medical Center
  • Walter Reed National Military Medical Center
  • National Institutes of Health Clinical Center
  • Community Research Initiative of New England
  • Boston Medical Center
  • Wayne State University
  • Henry Ford Health System
  • Newland Immunology Center of Excellence (NICE)
  • Hennepin County Medical Center
  • Mayo Clinic
  • Cooper University Hospital
  • New Jersey Medical School Adult Clinical Research Center
  • Bronx-Lebanon Hospital Center
  • Montefiore Medical Center
  • Cornell CRS
  • UNC AIDS Clinical Trials Unit
  • Duke University
  • Regional Center for Infectious Disease
  • Wake County Human Services
  • Wake Forest University Health Sciences
  • The Ohio State University Medical Center
  • The Research + Education Group - Portland
  • The Research and Education Group at Portland VA Research Foundation
  • Temple University
  • St. Jude Children's Research Hospital
  • UT Southwestern Clinical Research Unit
  • University of North Texas Health Science Center
  • Houston AIDS Research Team
  • Texas Children's Hospital
  • San Antonio Military Health System
  • Naval Medical Center Portsmouth
  • Virginia Commonwealth University
  • AIDS Resource Center of Wisconsin
  • Medical College of Wisconsin
  • Hospital Nacional Profesor Alejandro Posadas
  • Hospital Interzonal General de Agudos Dr. Diego Paroissien
  • CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)
  • FUNCEI
  • Fundacion IDEAA
  • Hospital General de Agudos JM Ramos Mejia
  • Hospital Italiano de Buenos Aires
  • Hospital Rawson
  • CEIN
  • Burwood Road General Practice
  • East Sydney Doctors
  • Holdsworth House Medical Practice
  • St. Vincent's Hospital
  • Taylor Square Private Clinic
  • Westmead Hospital
  • Sexual Health and HIV Service - Clinic 2
  • Royal Adelaide Hospital
  • The Alfred Hospital
  • Melbourne Sexual Health Centre
  • Prahran Market Clinic
  • Centre Clinic
  • Royal Perth Hospital
  • Otto-Wagner-Spital SMZ /Baumgartner Hoehe
  • University Vienna General Hospital
  • Institute of Tropical Medicine
  • Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)
  • Universitaire Ziekenhuizen Gent
  • Universitair Ziekenhuis Gasthuisberg
  • SEI - Servi�os Especializados em Infectologia
  • Center for Infectious Diseases at the UFES
  • Hospital Escola Sao Francisco de Assis - UFRJ
  • Ipec/Fiocruz
  • Instituto de Infectologia Emilio Ribas - IIER
  • Centro de Referencia e Treinamento DST/Aids
  • Lim 56/Hcfmusp
  • Fundacion Arriaran
  • University Hospital Plzen, CZ
  • Faculty Hospital Na Bulovce, Prague, Czech Rep.
  • Arhus Universitetshospital, Skejby
  • Rigshospitalet, Infektionsmedicinsk ambulatorium 8622
  • Hvidovre University Hospital, Department of Infectious Diseases
  • Odense University Hospital
  • West Tallinn Central Hospital Infectious Diseases
  • Helsinki University Central Hospital, Div. of Infectious Diseases CRS
  • CHU de Besan�on - H�pital Jean-Minjoz
  • CHU C�te de Nacre
  • H�pital Antoine Becl�re
  • H�pital Henri Mondor
  • H�pital de Bicetre
  • Groupe Hospitalier Pitie-Salpetri�re
  • H�pital Europeen Georges Pompidou
  • H�pital H�tel Dieu
  • H�pital Saint-Antoine
  • H�pital Saint-Louis
  • H�pital Foch
  • Centre Hospitalier - H�pital Gustave Dron
  • EPIMED-Gesellschaft fur epidemiologische und klinische Forschung in der MedizinmbH
  • Gemeinschaftspraxis Jessen-Jessen-Stein
  • Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS
  • Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
  • Klinikum Dortmund gGmbH
  • Universitatsklinikum Dusseldorf
  • Universitatsklinikum Erlangen
  • Klinik fur Dermatologie, Venerologie, Allergologie
  • Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS
  • ICH Study Center
  • Ifi - Studien und Projekte GmbH
  • Universitatsklinikum Hamburg-Eppendorf
  • Medizinische Hochschule Hannover
  • Universitatsklinikum Heidelberg
  • Klinikum der Universitat Munchen
  • Universitatsklinikum Regensburg
  • Universitatsklinikum Wurzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Infektiologie CRS
  • Attikon University General Hospital
  • Evangelismos General Hospital
  • Hippokration University General Hospital of Athens
  • Korgialenio-Benakio Hellenic Red Cross
  • Syngros Hospital
  • AHEPA University Hospital
  • Institute of Infectious Diseases
  • YRGCARE Medical Centre VHS, Chennai CRS
  • Mater Misericordiae University Hospital
  • Rambam Medical Center
  • Tel Aviv Sourasky Medical Center
  • Ospedale San Raffaele S.r.l.
  • Lazzaro Spallanzani IRCSS
  • Centre Hospitalier de Luxembourg
  • University Malaya Medical Centre
  • Serefo/Cesac Mali
  • INCMNSZ (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran)
  • University Hospital Centre Ibn Rochd
  • Institute of Human Virology-Nigeria (IHVN)
  • Oslo University Hospital, Ulleval
  • Via Libre
  • Asociacion Civil IMPACTA Salud y Educacion
  • Hospital Nacional Edgardo Rebagliati Martins
  • Hospital Nacional Guillermo Almenara Irigoyen
  • Asociacion Civil Impacta Salud y Educacion - Sede San Miguel
  • Uniwersytecki Szpital Kliniczny
  • Wojewodzki Szpital Zakazny
  • EMC Instytut Medyczny SA
  • Hospital Curry Cabral
  • Hospital de Egas Moniz
  • Hospital de Santa Maria
  • Hospital Joaquim Urbano
  • San Juan Hospital
  • University of Puerto Rico Pediatric Research Site
  • Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU)
  • Desmond Tutu HIV Foundation Clinical Trials Unit
  • Durban International Clinical Research Site (WWH)
  • Durban International Clinical Research Site
  • CHRU
  • 1 Military Hospital
  • Hospital Universitario Principe de Asturias
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Clinic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital del Mar
  • Hospital Clinico San Carlos
  • Hospital La Paz
  • Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS
  • Hospital Universitario Doce de Octubre
  • Hospital Universitari Mutua Terrassa
  • Hospital Universitario y Politecnico La Fe
  • Complejo Hospitalario Xeral Cies
  • Sahlgrenska University Hospital
  • Skane University Hospital
  • University Hospital Basel
  • Bern University Hospital
  • Unite VIH/SIDA Geneva
  • University Hospital Zurich
  • Siriraj Hospital
  • Chulalongkorn University Hospital
  • Ramathibodi Hospital
  • Sanpatong Hospital
  • Research Institute for Health Sciences (RIHES)
  • Chiangrai Prachanukroh Hospital
  • Chonburi Regional Hospital
  • Khon Kaen University, Srinagarind Hospital
  • Bamrasnaradura Institute
  • MRC/UVRI Research Unit on AIDS
  • Joint Clinical Research Center (JCRC)
  • Royal Berkshire Hospital
  • The James Cook University Hospital
  • Royal Bournemouth Hospital
  • Brighton and Sussex University Hospitals NHS Trust
  • Leicester Royal Infirmary
  • Belfast Health and Social Care Trust (RVH)
  • Sheffield Teaching Hospital NHS Foundation Trust
  • Queen Elizabeth Hospital Birmingham
  • Birmingham Heartlands Hospital
  • Coventry and Warwickshire NHS partnership Trust
  • Southmead Hospital
  • Gloucestershire Royal Hospital
  • Barts Health NHS Trust
  • Royal Free London NHS Foundation Trust
  • Guy's and St.Thomas' NHS Foundation Trust
  • Lewisham and Greenwich NHS Trust
  • Chelsea and Westminster Hospital
  • St. George's Healthcare NHS Trust
  • Imperial College Healthcare NHS Trust
  • University College London Medical School
  • North Manchester General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early ART

Deferred ART

Arm Description

Initiate ART immediately following randomization

Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops

Outcomes

Primary Outcome Measures

Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality

Secondary Outcome Measures

Components of the composite primary outcome measure
Specific non-AIDS diagnoses
Adverse events
Hospitalization, health-care utilization, quality of life
HIV drug resistance and transmission risk behavior
Change in neurocognitive function (in a subset of participants)
Obtain a whole blood sample from which DNA will be extracted to study validated genetic variants that determine the risk of the various primary and secondary outcomes assessed in START (in a subset of participants)
Evaluate understanding of study information and satisfaction with the consent process among START participants, after receiving information from either a standard or a concise consent form (at a subset of sites)
Large and small artery elasticity (in a subset of participants)
Rate of lung function decline (in a subset of participants)
Changes in bone mineral density (in a subset of participants)

Full Information

First Posted
March 20, 2009
Last Updated
March 8, 2023
Sponsor
University of Minnesota
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark, Medical Research Council, The Kirby Institute for Infection and Immunity in Society, Washington D.C. Veterans Affairs Medical Center, ANRS, Emerging Infectious Diseases, German Federal Ministry of Education and Research, NEAT - European AIDS Treatment Network, National Health and Medical Research Council, Australia, National Institutes of Health Clinical Center (CC), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme LLC, Tibotec Pharmaceutical Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT00867048
Brief Title
Strategic Timing of Antiretroviral Treatment
Acronym
START
Official Title
Strategic Timing of AntiRetroviral Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2009 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark, Medical Research Council, The Kirby Institute for Infection and Immunity in Society, Washington D.C. Veterans Affairs Medical Center, ANRS, Emerging Infectious Diseases, German Federal Ministry of Education and Research, NEAT - European AIDS Treatment Network, National Health and Medical Research Council, Australia, National Institutes of Health Clinical Center (CC), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme LLC, Tibotec Pharmaceutical Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
highly active antiretroviral therapy (HAART), CD4 Count, Early Intervention, HIV, HIV Infection, HIV Infections, treatment naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4688 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early ART
Arm Type
Experimental
Arm Description
Initiate ART immediately following randomization
Arm Title
Deferred ART
Arm Type
Active Comparator
Arm Description
Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops
Intervention Type
Drug
Intervention Name(s)
All licensed antiretroviral medications
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality
Time Frame
4.5 years
Secondary Outcome Measure Information:
Title
Components of the composite primary outcome measure
Time Frame
4.5 years
Title
Specific non-AIDS diagnoses
Time Frame
4.5 years
Title
Adverse events
Time Frame
4.5 years
Title
Hospitalization, health-care utilization, quality of life
Time Frame
4.5 years
Title
HIV drug resistance and transmission risk behavior
Time Frame
4.5 years
Title
Change in neurocognitive function (in a subset of participants)
Time Frame
4.5 years
Title
Obtain a whole blood sample from which DNA will be extracted to study validated genetic variants that determine the risk of the various primary and secondary outcomes assessed in START (in a subset of participants)
Time Frame
Blood taken at study entry and stored in a central repository indefinitely
Title
Evaluate understanding of study information and satisfaction with the consent process among START participants, after receiving information from either a standard or a concise consent form (at a subset of sites)
Time Frame
Before randomization into START
Title
Large and small artery elasticity (in a subset of participants)
Time Frame
4.5 years
Title
Rate of lung function decline (in a subset of participants)
Time Frame
4.5 years
Title
Changes in bone mineral density (in a subset of participants)
Time Frame
4.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Neaton, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdel Babiker, PhD
Organizational Affiliation
Medical Research Council Clinical Trials Unit, London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jens Lundgren, MD, DMSc
Organizational Affiliation
Copenhagen HIV Programme
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern California
City
Alhambra
State/Province
California
ZIP/Postal Code
91803
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
UCLA CARE-4-Families (LABAC CRS)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSD Mother-Child-Adolescent Program
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134-1201
Country
United States
Facility Name
Denver Public Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Washington DC VA Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
University of Florida Health Services Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Florida, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Florida Department of Health in Orange County/Sunshine Care Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32805
Country
United States
Facility Name
Infectious Diseases Associates NW FL, PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Hillsborough County Health Deptment/University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
AIDS Research and Treatment Center of the Treasure Coast
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Mt. Sinai Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2605
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Community Research Initiative of New England
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Newland Immunology Center of Excellence (NICE)
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New Jersey Medical School Adult Clinical Research Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx-Lebanon Hospital Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Cornell CRS
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
UNC AIDS Clinical Trials Unit
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Regional Center for Infectious Disease
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401-1209
Country
United States
Facility Name
Wake County Human Services
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1042
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Research + Education Group - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Research and Education Group at Portland VA Research Foundation
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-3678
Country
United States
Facility Name
UT Southwestern Clinical Research Unit
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Houston AIDS Research Team
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio Military Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
AIDS Resource Center of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53203
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Nacional Profesor Alejandro Posadas
City
El Palomar
State/Province
Buenos Aires
Country
Argentina
Facility Name
Hospital Interzonal General de Agudos Dr. Diego Paroissien
City
Isidro Casanova
State/Province
Buenos Aires
Country
Argentina
Facility Name
CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
FUNCEI
City
Buenos Aires
Country
Argentina
Facility Name
Fundacion IDEAA
City
Buenos Aires
Country
Argentina
Facility Name
Hospital General de Agudos JM Ramos Mejia
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Rawson
City
Cordoba
Country
Argentina
Facility Name
CEIN
City
Neuquen
Country
Argentina
Facility Name
Burwood Road General Practice
City
Burwood
State/Province
New South Wales
ZIP/Postal Code
2134
Country
Australia
Facility Name
East Sydney Doctors
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Sexual Health and HIV Service - Clinic 2
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Melbourne Sexual Health Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Prahran Market Clinic
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Centre Clinic
City
St Kilda
State/Province
Victoria
ZIP/Postal Code
3182
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Otto-Wagner-Spital SMZ /Baumgartner Hoehe
City
Vienna
Country
Austria
Facility Name
University Vienna General Hospital
City
Vienna
Country
Austria
Facility Name
Institute of Tropical Medicine
City
Antwerp
Country
Belgium
Facility Name
Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)
City
Brussels
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Gent
City
Ghent
Country
Belgium
Facility Name
Universitair Ziekenhuis Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
SEI - Servi�os Especializados em Infectologia
City
Salvador
State/Province
BA
ZIP/Postal Code
40110-010
Country
Brazil
Facility Name
Center for Infectious Diseases at the UFES
City
Vitoria
State/Province
ES
ZIP/Postal Code
29040-091
Country
Brazil
Facility Name
Hospital Escola Sao Francisco de Assis - UFRJ
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20210-030
Country
Brazil
Facility Name
Ipec/Fiocruz
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21040-900
Country
Brazil
Facility Name
Instituto de Infectologia Emilio Ribas - IIER
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Centro de Referencia e Treinamento DST/Aids
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04121-000
Country
Brazil
Facility Name
Lim 56/Hcfmusp
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Fundacion Arriaran
City
Santiago
Country
Chile
Facility Name
University Hospital Plzen, CZ
City
Plzen
Country
Czechia
Facility Name
Faculty Hospital Na Bulovce, Prague, Czech Rep.
City
Prague
Country
Czechia
Facility Name
Arhus Universitetshospital, Skejby
City
Aarhus
Country
Denmark
Facility Name
Rigshospitalet, Infektionsmedicinsk ambulatorium 8622
City
Copenhagen
Country
Denmark
Facility Name
Hvidovre University Hospital, Department of Infectious Diseases
City
Hvidovre
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
West Tallinn Central Hospital Infectious Diseases
City
Tallinn
Country
Estonia
Facility Name
Helsinki University Central Hospital, Div. of Infectious Diseases CRS
City
Helsinki
Country
Finland
Facility Name
CHU de Besan�on - H�pital Jean-Minjoz
City
Besancon
Country
France
Facility Name
CHU C�te de Nacre
City
Caen
Country
France
Facility Name
H�pital Antoine Becl�re
City
Clamart
Country
France
Facility Name
H�pital Henri Mondor
City
Creteil
Country
France
Facility Name
H�pital de Bicetre
City
Le Kremlin-Bicetre
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetri�re
City
Paris
Country
France
Facility Name
H�pital Europeen Georges Pompidou
City
Paris
Country
France
Facility Name
H�pital H�tel Dieu
City
Paris
Country
France
Facility Name
H�pital Saint-Antoine
City
Paris
Country
France
Facility Name
H�pital Saint-Louis
City
Paris
Country
France
Facility Name
H�pital Foch
City
Suresnes
Country
France
Facility Name
Centre Hospitalier - H�pital Gustave Dron
City
Tourcoing
Country
France
Facility Name
EPIMED-Gesellschaft fur epidemiologische und klinische Forschung in der MedizinmbH
City
Berlin
Country
Germany
Facility Name
Gemeinschaftspraxis Jessen-Jessen-Stein
City
Berlin
Country
Germany
Facility Name
Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS
City
Bonn
Country
Germany
Facility Name
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
City
Cologne
Country
Germany
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
Country
Germany
Facility Name
Universitatsklinikum Dusseldorf
City
Duesseldorf
Country
Germany
Facility Name
Universitatsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Klinik fur Dermatologie, Venerologie, Allergologie
City
Essen
Country
Germany
Facility Name
Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS
City
Frankfurt
Country
Germany
Facility Name
ICH Study Center
City
Hamburg
Country
Germany
Facility Name
Ifi - Studien und Projekte GmbH
City
Hamburg
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hanover
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Klinikum der Universitat Munchen
City
Munich
Country
Germany
Facility Name
Universitatsklinikum Regensburg
City
Regensburg
Country
Germany
Facility Name
Universitatsklinikum Wurzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Infektiologie CRS
City
Wuerzburg
Country
Germany
Facility Name
Attikon University General Hospital
City
Athens
Country
Greece
Facility Name
Evangelismos General Hospital
City
Athens
Country
Greece
Facility Name
Hippokration University General Hospital of Athens
City
Athens
Country
Greece
Facility Name
Korgialenio-Benakio Hellenic Red Cross
City
Athens
Country
Greece
Facility Name
Syngros Hospital
City
Athens
Country
Greece
Facility Name
AHEPA University Hospital
City
Thessaloniki
Country
Greece
Facility Name
Institute of Infectious Diseases
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411037
Country
India
Facility Name
YRGCARE Medical Centre VHS, Chennai CRS
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600113
Country
India
Facility Name
Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Ospedale San Raffaele S.r.l.
City
Milan
State/Province
MI
Country
Italy
Facility Name
Lazzaro Spallanzani IRCSS
City
Rome
State/Province
RM
Country
Italy
Facility Name
Centre Hospitalier de Luxembourg
City
Luxembourg
Country
Luxembourg
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
State/Province
Federal Territory
Country
Malaysia
Facility Name
Serefo/Cesac Mali
City
Bamako
Country
Mali
Facility Name
INCMNSZ (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran)
City
Tlalpan
Country
Mexico
Facility Name
University Hospital Centre Ibn Rochd
City
Casablanca
ZIP/Postal Code
20360
Country
Morocco
Facility Name
Institute of Human Virology-Nigeria (IHVN)
City
Abuja
State/Province
FCT
Country
Nigeria
Facility Name
Oslo University Hospital, Ulleval
City
Oslo
Country
Norway
Facility Name
Via Libre
City
Lima
ZIP/Postal Code
01
Country
Peru
Facility Name
Asociacion Civil IMPACTA Salud y Educacion
City
Lima
ZIP/Postal Code
04
Country
Peru
Facility Name
Hospital Nacional Edgardo Rebagliati Martins
City
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen
City
Lima
ZIP/Postal Code
13
Country
Peru
Facility Name
Asociacion Civil Impacta Salud y Educacion - Sede San Miguel
City
Lima
ZIP/Postal Code
32
Country
Peru
Facility Name
Uniwersytecki Szpital Kliniczny
City
Bialystok
Country
Poland
Facility Name
Wojewodzki Szpital Zakazny
City
Warsaw
Country
Poland
Facility Name
EMC Instytut Medyczny SA
City
Wroclaw
Country
Poland
Facility Name
Hospital Curry Cabral
City
Lisbon
Country
Portugal
Facility Name
Hospital de Egas Moniz
City
Lisbon
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisbon
Country
Portugal
Facility Name
Hospital Joaquim Urbano
City
Oporto
Country
Portugal
Facility Name
San Juan Hospital
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
University of Puerto Rico Pediatric Research Site
City
San Juan
ZIP/Postal Code
00935-6528
Country
Puerto Rico
Facility Name
Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU)
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Desmond Tutu HIV Foundation Clinical Trials Unit
City
Cape Town
Country
South Africa
Facility Name
Durban International Clinical Research Site (WWH)
City
Durban
Country
South Africa
Facility Name
Durban International Clinical Research Site
City
Durban
Country
South Africa
Facility Name
CHRU
City
Johannesburg
Country
South Africa
Facility Name
1 Military Hospital
City
Pretoria
Country
South Africa
Facility Name
Hospital Universitario Principe de Asturias
City
Alcala de Henares
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitari Mutua Terrassa
City
Terrassa
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
Country
Spain
Facility Name
Complejo Hospitalario Xeral Cies
City
Vigo
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Skane University Hospital
City
Malmo
Country
Sweden
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Facility Name
Bern University Hospital
City
Bern
Country
Switzerland
Facility Name
Unite VIH/SIDA Geneva
City
Geneva
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zurich
Country
Switzerland
Facility Name
Siriraj Hospital
City
Bangkok Noi
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chulalongkorn University Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Sanpatong Hospital
City
Chiang Mai
ZIP/Postal Code
50120
Country
Thailand
Facility Name
Research Institute for Health Sciences (RIHES)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Chiangrai Prachanukroh Hospital
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Chonburi Regional Hospital
City
Chon Buri
ZIP/Postal Code
20000
Country
Thailand
Facility Name
Khon Kaen University, Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
MRC/UVRI Research Unit on AIDS
City
Entebbe
Country
Uganda
Facility Name
Joint Clinical Research Center (JCRC)
City
Kampala
Country
Uganda
Facility Name
Royal Berkshire Hospital
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 5LE
Country
United Kingdom
Facility Name
The James Cook University Hospital
City
Middlesbrough
State/Province
Cleveland
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust (RVH)
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Sheffield Teaching Hospital NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Coventry and Warwickshire NHS partnership Trust
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV1 4FS
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's and St.Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Lewisham and Greenwich NHS Trust
City
London
ZIP/Postal Code
SE18 4QH
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
St. George's Healthcare NHS Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
University College London Medical School
City
London
ZIP/Postal Code
WC1E 6JB
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22547421
Citation
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.
Results Reference
background
PubMed Identifier
26192873
Citation
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.
Results Reference
result
PubMed Identifier
33974707
Citation
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.
Results Reference
derived
PubMed Identifier
31800000
Citation
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.
Results Reference
derived
PubMed Identifier
31764099
Citation
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.
Results Reference
derived
PubMed Identifier
31647325
Citation
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.
Results Reference
derived
PubMed Identifier
31250552
Citation
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.
Results Reference
derived
PubMed Identifier
30032171
Citation
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.
Results Reference
derived
PubMed Identifier
29352723
Citation
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.
Results Reference
derived
PubMed Identifier
29244111
Citation
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.
Results Reference
derived
PubMed Identifier
28533305
Citation
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.
Results Reference
derived
PubMed Identifier
28445471
Citation
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.
Results Reference
derived
PubMed Identifier
28063815
Citation
O'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.
Results Reference
derived
PubMed Identifier
26908541
Citation
Larson 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.
Results Reference
derived
PubMed Identifier
25711332
Citation
Carr 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.
Results Reference
derived
PubMed Identifier
25711331
Citation
Matthews 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 1:129-36. doi: 10.1111/hiv.12241.
Results Reference
derived
PubMed Identifier
25711330
Citation
Kunisaki 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.
Results Reference
derived
PubMed Identifier
25711329
Citation
Baker 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.
Results Reference
derived
PubMed Identifier
25711328
Citation
Wright 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.
Results Reference
derived
PubMed Identifier
25711327
Citation
Lifson 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.
Results Reference
derived
PubMed Identifier
25711326
Citation
Baxter 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.
Results Reference
derived
PubMed Identifier
25711325
Citation
Rodger 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.
Results Reference
derived
PubMed Identifier
25711324
Citation
Achhra 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.
Results Reference
derived
PubMed Identifier
25711323
Citation
Soliman 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.
Results Reference
derived
PubMed Identifier
25711322
Citation
Law 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.
Results Reference
derived
PubMed Identifier
25711321
Citation
Sharma 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.
Results Reference
derived
PubMed Identifier
25711320
Citation
Denning 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.
Results Reference
derived
PubMed Identifier
25711319
Citation
Grarup 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.
Results Reference
derived
PubMed Identifier
25711318
Citation
Geffen 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.
Results Reference
derived
PubMed Identifier
25711317
Citation
INSIGHT 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.
Results Reference
derived
PubMed Identifier
21951596
Citation
Kunisaki 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.
Results Reference
derived
Links:
URL
http://www.insight-trials.org
Description
INSIGHT network website, including information on the START trial

Learn more about this trial

Strategic Timing of Antiretroviral Treatment

We'll reach out to this number within 24 hrs