MedPath

Strategic Timing of Antiretroviral Treatment

Phase 4
Completed
Conditions
HIV Infection
Interventions
Drug: All licensed antiretroviral medications
Registration Number
NCT00867048
Lead Sponsor
University of Minnesota
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4688
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Early ARTAll licensed antiretroviral medicationsInitiate ART immediately following randomization
Deferred ARTAll licensed antiretroviral medicationsDefer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops
Primary Outcome Measures
NameTimeMethod
Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortalityfull follow-up, 9.3 years
Secondary Outcome Measures
NameTimeMethod
Death, All-cause Mortalityfull follow-up, 9.3 years

Count of participants

Changes in Bone Mineral Density (in a Subset of Participants) Measure 14.5 years

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.

Specific Non-AIDS Diagnosesfull follow-up, 9.3 years
Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health4.5 years

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).

Large Artery Elasticity (in a Subset of Participants)4.5 years

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.

AIDs or AIDs Related Deathfull follow-up, 9.3 years

participant count

Transmission Risk Behavior Outcome 112 months

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.

Changes in Bone Mineral Density (in a Subset of Participants) Measure 24.5 years

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.

Change in Neurocognitive Function (in a Subset of Participants)4.5 years

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.

Transmission Risk Behavior Outcome 212 month visit

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.

Small Artery Elasticity (in a Subset of Participants)4.5 years

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.

Rate of Lung Function Decline (in a Subset of Participants) Among4.5 years

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.

Rate of Lung Function Decline (in a Subset of Participants) Among Non-smokers4.5 years

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.

Trial Locations

Locations (218)

FUNCEI

🇦🇷

Buenos Aires, Argentina

Fundacion IDEAA

🇦🇷

Buenos Aires, Argentina

Sanpatong Hospital

🇹🇭

Chiang Mai, Thailand

Chiangrai Prachanukroh Hospital

🇹🇭

Chiang Rai, Thailand

Chonburi Regional Hospital

🇹🇭

Chon Buri, Thailand

Lurie Children's Hospital

🇺🇸

Chicago, Illinois, United States

Houston AIDS Research Team

🇺🇸

Houston, Texas, United States

Texas Children's Hospital

🇺🇸

Houston, Texas, United States

University Hospital Basel

🇨🇭

Basel, Switzerland

VA Greater Los Angeles Healthcare System

🇺🇸

Los Angeles, California, United States

UCLA CARE-4-Families (LABAC CRS)

🇺🇸

Los Angeles, California, United States

University of Florida Health Services Center

🇺🇸

Jacksonville, Florida, United States

Mt. Sinai Hospital

🇺🇸

Chicago, Illinois, United States

University of North Texas Health Science Center

🇺🇸

Fort Worth, Texas, United States

Bronx-Lebanon Hospital Center

🇺🇸

Bronx, New York, United States

Infectious Diseases Associates NW FL, PA

🇺🇸

Pensacola, Florida, United States

Hospital Rawson

🇦🇷

Cordoba, Argentina

Temple University

🇺🇸

Philadelphia, Pennsylvania, United States

University of Florida, Jacksonville

🇺🇸

Jacksonville, Florida, United States

AIDS Research and Treatment Center of the Treasure Coast

🇺🇸

Vero Beach, Florida, United States

Rigshospitalet, Infektionsmedicinsk ambulatorium 8622

🇩🇰

Copenhagen, Denmark

St. Jude Children's Research Hospital

🇺🇸

Memphis, Tennessee, United States

Holdsworth House Medical Practice

🇦🇺

Darlinghurst, New South Wales, Australia

Royal Adelaide Hospital

🇦🇺

Adelaide, South Australia, Australia

UT Southwestern Clinical Research Unit

🇺🇸

Dallas, Texas, United States

Naval Medical Center Portsmouth

🇺🇸

Portsmouth, Virginia, United States

CEIN

🇦🇷

Neuquen, Argentina

Institute of Tropical Medicine

🇧🇪

Antwerp, Belgium

Burwood Road General Practice

🇦🇺

Burwood, New South Wales, Australia

Centre Clinic

🇦🇺

St Kilda, Victoria, Australia

East Sydney Doctors

🇦🇺

Darlinghurst, New South Wales, Australia

Taylor Square Private Clinic

🇦🇺

Darlinghurst, New South Wales, Australia

Center for Infectious Diseases at the UFES

🇧🇷

Vitoria, ES, Brazil

Westmead Hospital

🇦🇺

Westmead, New South Wales, Australia

Centro de Referencia e Treinamento DST/Aids

🇧🇷

Sao Paulo, SP, Brazil

Fundacion Arriaran

🇨🇱

Santiago, Chile

University Hospital Plzen, CZ

🇨🇿

Plzen, Czechia

Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS

🇪🇸

Madrid, Spain

H�pital Saint-Antoine

🇫🇷

Paris, France

Hospital de la Santa Creu i Sant Pau

🇪🇸

Barcelona, Spain

Hospital Universitari Germans Trias i Pujol

🇪🇸

Badalona, Spain

Hospital Clinic de Barcelona

🇪🇸

Barcelona, Spain

Hospital Joaquim Urbano

🇵🇹

Oporto, Portugal

1 Military Hospital

🇿🇦

Pretoria, South Africa

Khon Kaen University, Srinagarind Hospital

🇹🇭

Khon Kaen, Thailand

Hospital Universitario Principe de Asturias

🇪🇸

Alcala de Henares, Spain

Desmond Tutu HIV Foundation Clinical Trials Unit

🇿🇦

Cape Town, South Africa

Durban International Clinical Research Site (WWH)

🇿🇦

Durban, South Africa

San Juan Hospital

🇵🇷

Rio Piedras, Puerto Rico

Hospital del Mar

🇪🇸

Barcelona, Spain

University of Puerto Rico Pediatric Research Site

🇵🇷

San Juan, Puerto Rico

Bern University Hospital

🇨🇭

Bern, Switzerland

Sahlgrenska University Hospital

🇸🇪

Gothenburg, Sweden

Unite VIH/SIDA Geneva

🇨🇭

Geneva, Switzerland

Skane University Hospital

🇸🇪

Malmo, Sweden

The James Cook University Hospital

🇬🇧

Middlesbrough, Cleveland, United Kingdom

Durban International Clinical Research Site

🇿🇦

Durban, South Africa

Guy's and St.Thomas' NHS Foundation Trust

🇬🇧

London, United Kingdom

North Manchester General Hospital

🇬🇧

Manchester, United Kingdom

Complejo Hospitalario Xeral Cies

🇪🇸

Vigo, Spain

University Hospital Zurich

🇨🇭

Zurich, Switzerland

Royal Berkshire Hospital

🇬🇧

Reading, Berkshire, United Kingdom

Coventry and Warwickshire NHS partnership Trust

🇬🇧

Coventry, West Midlands, United Kingdom

Queen Elizabeth Hospital Birmingham

🇬🇧

Birmingham, West Midlands, United Kingdom

Southmead Hospital

🇬🇧

Bristol, United Kingdom

Chelsea and Westminster Hospital

🇬🇧

London, United Kingdom

Imperial College Healthcare NHS Trust

🇬🇧

London, United Kingdom

UCSD Mother-Child-Adolescent Program

🇺🇸

San Diego, California, United States

Naval Medical Center San Diego

🇺🇸

San Diego, California, United States

Duke University

🇺🇸

Durham, North Carolina, United States

San Antonio Military Health System

🇺🇸

San Antonio, Texas, United States

MRC/UVRI Research Unit on AIDS

🇺🇬

Entebbe, Uganda

Joint Clinical Research Center (JCRC)

🇺🇬

Kampala, Uganda

University of Southern California

🇺🇸

Alhambra, California, United States

Royal Perth Hospital

🇦🇺

Perth, Western Australia, Australia

YRGCARE Medical Centre VHS, Chennai CRS

🇮🇳

Chennai, Tamil Nadu, India

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

Denver Public Health

🇺🇸

Denver, Colorado, United States

Wayne State University

🇺🇸

Detroit, Michigan, United States

Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

The Research + Education Group - Portland

🇺🇸

Portland, Oregon, United States

The Research and Education Group at Portland VA Research Foundation

🇺🇸

Portland, Oregon, United States

Lim 56/Hcfmusp

🇧🇷

Sao Paulo, SP, Brazil

Groupe Hospitalier Pitie-Salpetri�re

🇫🇷

Paris, France

Birmingham Heartlands Hospital

🇬🇧

Birmingham, West Midlands, United Kingdom

St. George's Healthcare NHS Trust

🇬🇧

London, United Kingdom

Gloucestershire Royal Hospital

🇬🇧

Gloucester, United Kingdom

Hospital Escola Sao Francisco de Assis - UFRJ

🇧🇷

Rio de Janeiro, RJ, Brazil

CHRU

🇿🇦

Johannesburg, South Africa

Hospital Universitario y Politecnico La Fe

🇪🇸

Valencia, Spain

Hospital Clinico San Carlos

🇪🇸

Madrid, Spain

Hospital Universitari Mutua Terrassa

🇪🇸

Terrassa, Spain

Hospital Universitario Doce de Octubre

🇪🇸

Madrid, Spain

Hospital La Paz

🇪🇸

Madrid, Spain

University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

H�pital de Bicetre

🇫🇷

Le Kremlin-Bicetre, France

Gemeinschaftspraxis Jessen-Jessen-Stein

🇩🇪

Berlin, Germany

George Washington Medical Faculty Associates

🇺🇸

Washington, District of Columbia, United States

Community Research Initiative of New England

🇺🇸

Boston, Massachusetts, United States

Newland Immunology Center of Excellence (NICE)

🇺🇸

Southfield, Michigan, United States

Hennepin County Medical Center

🇺🇸

Minneapolis, Minnesota, United States

Wake County Human Services

🇺🇸

Raleigh, North Carolina, United States

Cornell CRS

🇺🇸

New York, New York, United States

Regional Center for Infectious Disease

🇺🇸

Greensboro, North Carolina, United States

The Ohio State University Medical Center

🇺🇸

Columbus, Ohio, United States

St. Vincent's Hospital

🇦🇺

Darlinghurst, New South Wales, Australia

Sexual Health and HIV Service - Clinic 2

🇦🇺

Brisbane, Queensland, Australia

Melbourne Sexual Health Centre

🇦🇺

Melbourne, Victoria, Australia

Otto-Wagner-Spital SMZ /Baumgartner Hoehe

🇦🇹

Vienna, Austria

University Vienna General Hospital

🇦🇹

Vienna, Austria

Universitaire Ziekenhuizen Gent

🇧🇪

Ghent, Belgium

Universitair Ziekenhuis Gasthuisberg

🇧🇪

Leuven, Belgium

SEI - Servi�os Especializados em Infectologia

🇧🇷

Salvador, BA, Brazil

Ipec/Fiocruz

🇧🇷

Rio de Janeiro, RJ, Brazil

Instituto de Infectologia Emilio Ribas - IIER

🇧🇷

Sao Paulo, SP, Brazil

Arhus Universitetshospital, Skejby

🇩🇰

Aarhus, Denmark

Faculty Hospital Na Bulovce, Prague, Czech Rep.

🇨🇿

Prague, Czechia

Hvidovre University Hospital, Department of Infectious Diseases

🇩🇰

Hvidovre, Denmark

Odense University Hospital

🇩🇰

Odense, Denmark

West Tallinn Central Hospital Infectious Diseases

🇪🇪

Tallinn, Estonia

Helsinki University Central Hospital, Div. of Infectious Diseases CRS

🇫🇮

Helsinki, Finland

CHU C�te de Nacre

🇫🇷

Caen, France

CHU de Besan�on - H�pital Jean-Minjoz

🇫🇷

Besancon, France

H�pital Antoine Becl�re

🇫🇷

Clamart, France

H�pital Henri Mondor

🇫🇷

Creteil, France

H�pital H�tel Dieu

🇫🇷

Paris, France

H�pital Europeen Georges Pompidou

🇫🇷

Paris, France

H�pital Saint-Louis

🇫🇷

Paris, France

EPIMED-Gesellschaft fur epidemiologische und klinische Forschung in der MedizinmbH

🇩🇪

Berlin, Germany

Centre Hospitalier - H�pital Gustave Dron

🇫🇷

Tourcoing, France

H�pital Foch

🇫🇷

Suresnes, France

Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS

🇩🇪

Bonn, Germany

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

🇩🇪

Cologne, Germany

Universitatsklinikum Dusseldorf

🇩🇪

Duesseldorf, Germany

Klinikum Dortmund gGmbH

🇩🇪

Dortmund, Germany

Klinik fur Dermatologie, Venerologie, Allergologie

🇩🇪

Essen, Germany

Universitatsklinikum Erlangen

🇩🇪

Erlangen, Germany

Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS

🇩🇪

Frankfurt, Germany

ICH Study Center

🇩🇪

Hamburg, Germany

Ifi - Studien und Projekte GmbH

🇩🇪

Hamburg, Germany

Medizinische Hochschule Hannover

🇩🇪

Hanover, Germany

Universitatsklinikum Heidelberg

🇩🇪

Heidelberg, Germany

Klinikum der Universitat Munchen

🇩🇪

Munich, Germany

Universitatsklinikum Hamburg-Eppendorf

🇩🇪

Hamburg, Germany

Universitatsklinikum Regensburg

🇩🇪

Regensburg, Germany

Attikon University General Hospital

🇬🇷

Athens, Greece

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

🇩🇪

Wuerzburg, Germany

Evangelismos General Hospital

🇬🇷

Athens, Greece

Korgialenio-Benakio Hellenic Red Cross

🇬🇷

Athens, Greece

Syngros Hospital

🇬🇷

Athens, Greece

Hippokration University General Hospital of Athens

🇬🇷

Athens, Greece

AHEPA University Hospital

🇬🇷

Thessaloniki, Greece

Institute of Infectious Diseases

🇮🇳

Pune, Maharashtra, India

Mater Misericordiae University Hospital

🇮🇪

Dublin, Ireland

Tel Aviv Sourasky Medical Center

🇮🇱

Tel Aviv, Israel

Rambam Medical Center

🇮🇱

Haifa, Israel

Centre Hospitalier de Luxembourg

🇱🇺

Luxembourg, Luxembourg

Lazzaro Spallanzani IRCSS

🇮🇹

Rome, RM, Italy

Ospedale San Raffaele S.r.l.

🇮🇹

Milan, MI, Italy

University Malaya Medical Centre

🇲🇾

Kuala Lumpur, Federal Territory, Malaysia

Serefo/Cesac Mali

🇲🇱

Bamako, Mali

Hospital Nacional Edgardo Rebagliati Martins

🇵🇪

Lima, Peru

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

🇲🇽

Tlalpan, Mexico

University Hospital Centre Ibn Rochd

🇲🇦

Casablanca, Morocco

Via Libre

🇵🇪

Lima, Peru

Institute of Human Virology-Nigeria (IHVN)

🇳🇬

Abuja, FCT, Nigeria

Oslo University Hospital, Ulleval

🇳🇴

Oslo, Norway

Hospital Nacional Guillermo Almenara Irigoyen

🇵🇪

Lima, Peru

Asociacion Civil Impacta Salud y Educacion - Sede San Miguel

🇵🇪

Lima, Peru

Uniwersytecki Szpital Kliniczny

🇵🇱

Bialystok, Poland

Hospital de Egas Moniz

🇵🇹

Lisbon, Portugal

Wojewodzki Szpital Zakazny

🇵🇱

Warsaw, Poland

EMC Instytut Medyczny SA

🇵🇱

Wroclaw, Poland

Hospital Curry Cabral

🇵🇹

Lisbon, Portugal

Hospital de Santa Maria

🇵🇹

Lisbon, Portugal

Royal Bournemouth Hospital

🇬🇧

Bournemouth, Dorset, United Kingdom

Sheffield Teaching Hospital NHS Foundation Trust

🇬🇧

Sheffield, South Yorkshire, United Kingdom

Belfast Health and Social Care Trust (RVH)

🇬🇧

Belfast, Northern Ireland, United Kingdom

Leicester Royal Infirmary

🇬🇧

Leicester, Leicestershire, United Kingdom

Barts Health NHS Trust

🇬🇧

London, United Kingdom

Lewisham and Greenwich NHS Trust

🇬🇧

London, United Kingdom

University College London Medical School

🇬🇧

London, United Kingdom

Yale University School of Medicine

🇺🇸

New Haven, Connecticut, United States

Florida Department of Health in Orange County/Sunshine Care Center

🇺🇸

Orlando, Florida, United States

Hillsborough County Health Deptment/University of South Florida

🇺🇸

Tampa, Florida, United States

Walter Reed National Military Medical Center

🇺🇸

Bethesda, Maryland, United States

National Institutes of Health Clinical Center

🇺🇸

Bethesda, Maryland, United States

Wake Forest University Health Sciences

🇺🇸

Winston-Salem, North Carolina, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

UNC AIDS Clinical Trials Unit

🇺🇸

Chapel Hill, North Carolina, United States

AIDS Resource Center of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

New Jersey Medical School Adult Clinical Research Center

🇺🇸

Newark, New Jersey, United States

University of Miami

🇺🇸

Miami, Florida, United States

Orlando Immunology Center

🇺🇸

Orlando, Florida, United States

Georgetown University

🇺🇸

Washington, District of Columbia, United States

Washington DC VA Medical Center

🇺🇸

Washington, District of Columbia, United States

Tulane University Medical Center

🇺🇸

New Orleans, Louisiana, United States

Hospital Nacional Profesor Alejandro Posadas

🇦🇷

El Palomar, Buenos Aires, Argentina

Hospital Interzonal General de Agudos Dr. Diego Paroissien

🇦🇷

Isidro Casanova, Buenos Aires, Argentina

Hospital General de Agudos JM Ramos Mejia

🇦🇷

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

🇦🇷

Buenos Aires, Argentina

Cooper University Hospital

🇺🇸

Camden, New Jersey, United States

CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)

🇦🇷

Rosario, Santa Fe, Argentina

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

🇧🇪

Brussels, Belgium

Asociacion Civil IMPACTA Salud y Educacion

🇵🇪

Lima, Peru

Chulalongkorn University Hospital

🇹🇭

Bangkok, Thailand

Bamrasnaradura Institute

🇹🇭

Nonthaburi, Thailand

Brighton and Sussex University Hospitals NHS Trust

🇬🇧

Brighton, East Sussex, United Kingdom

The Alfred Hospital

🇦🇺

Melbourne, Victoria, Australia

Prahran Market Clinic

🇦🇺

Melbourne, Victoria, Australia

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

🇵🇷

San Juan, Puerto Rico

Siriraj Hospital

🇹🇭

Bangkok Noi, Thailand

Ramathibodi Hospital

🇹🇭

Bangkok, Thailand

Research Institute for Health Sciences (RIHES)

🇹🇭

Chiang Mai, Thailand

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

Royal Free London NHS Foundation Trust

🇬🇧

London, United Kingdom

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