A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)

November 24, 2009 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies.

Study Overview

Status

Completed

Conditions

Detailed Description

Implementation of antiretroviral treatment (ART) guidelines, which emphasize maximal and durable suppression of viral load for the majority of individuals infected with HIV, has resulted in a substantial decline in morbidity and mortality. However, many asymptomatic patients are not at immediate risk of serious opportunistic diseases, the effectiveness of ART wanes over time due to HIV drug resistance, and there are short- and long-term toxicities of treatment. This motivates a comparison of two strategies: one which conserves treatments by deferring their use while the risk of opportunistic disease is low and one which aims for sustained virologic suppression, irrespective of disease risk.

In this large, long-term trial, patients will be randomly assigned to either the drug conservation (DC) or viral suppression (VS) group. Patients will be enrolled over a 3-year period and followed for an average of 7.5 years. The DC group will stop or defer ART until CD4 cell count declines to below 250 cells/mm3; they will then receive treatment to increase CD4 count to greater than 350 cells/mm3 followed by episodic ART based on CD4 cell count. The VS group will use ART to maintain viral load as low as possible, irrespective of CD4 cell count. Patients will be seen Months 1, 2, 4, 6, 8, 10, and 12, then every 4 months for data collection visits. All available ARTs, including immunomodulators, and resistance testing may be used by patients in both treatment groups. Selected subsamples of patients enrolled in the study will be followed with more intensive data collection for secondary outcomes relating to cost and health care utilization, quality of life, HIV transmission risk behaviors, and metabolic complications of treatment.

Study Type

Observational

Enrollment

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina
        • Hospital de Clinicas Jose de San Martin
      • Buenos Aires, Argentina
        • Hospital de Infecciosas F.J. Muniz
      • Buenos Aires, Argentina
        • Hospital Gn'l de Agudos JM Ramos Mejia
      • Buenos Aires, Argentina
        • Hospital Gn'l de Agudos T. Alvarez
      • Cordoba, Argentina
        • Hospital Rawson
      • La Plata, Argentina
        • Hospital Interzonall de San Juan de Dios
      • Mendoza, Argentina
        • Hospital Central
      • Rosario, Argentina
        • CAICI
  • Australia
      • Burwood Nsw, Australia, 2134
        • Burwood Street General Pratice
      • Perth, Australia
        • Royal Perth Hosp
      • Prahan, Australia
        • Alfred Hosp
      • Prahan, Australia
        • Royal Prince Alfred Hospital
      • Sydney, Australia
        • National Centre in HIV Epidemiology and Clinical Research
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
    • Victoria
      • South Yarra, Victoria, Australia
        • Prahran Market Clinic
      • South Yarra, Victoria, Australia
        • The Centre Clinic
  • Austria
      • Vienna, Austria, A-1090
        • University of Vienna Medical School, AKH
  • Belgium
      • Antwerp, Belgium, 2000
        • Institute of Tropical Medicine
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire Sart-Tilman
  • Brazil
      • Boqueirao-Santos, Brazil, 11045-904
        • Cassiano Antonio de Moraes University Hospital
      • Boqueirao-Santos, Brazil, 11045-904
        • Centro de Pesquisa Clinical do Hospital Guilherme
      • Porto Alegre-RS Cep, Brazil, 90035
        • Hospital de Clinicas de Porto Alegre
      • Rio de Janeiro, Brazil, 20221-903
        • Hospital dos Servidores do Estado
      • Salvador-BA, Brazil, 110-160
        • Hospital Universitario Professor Edgard Santos
      • San Paulo, Brazil, 04121-000
        • Centro de Referência e Treinamento DST/AIDS
      • San Paulo, Brazil, 13083-970
        • Unidade de Pesquisa Clínica
      • Sao Paulo, Brazil, 01246-900
        • Ambulatorio de Imunodeficiencias Secundarias/Der30
      • Sao Paulo, Brazil, 04040-002
        • Universidade Federal De Sao Paulo-Hospital Sao Paulo
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20210.030
        • Hospital Escola Sao Francisco de Asis
    • RS
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
    • S.p. Cep
      • Sao Paulo, S.p. Cep, Brazil, 01246
        • Instituto de Infectologia Emilio Ribas
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Downtown Infectious Disease Clinic
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, NS B3H 1V7
        • Queen Elizabeth Ii Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Science Centre-McMaster
      • London, Ontario, Canada, N5Y 3H6
        • St. Joseph's Health Care Centre of London
      • London, Ontario, Canada
        • St. Josephs Hospital
      • Sudbury, Ontario, Canada, P3E 5J1
        • The HAVEN Program, HRSRH
      • Toronto, Ontario, Canada, M5G 2N2
        • Tronto General Hospital
      • Windsor, Ontario, Canada, N8W 1E3
        • HIV Care Program, Windsor Regional Hospital
    • Quebec
      • Fleurimont, Quebec, Canada, JIH 5N4
        • University de Sherbrooke
      • Montreal, Quebec, Canada, H2L 4P9
        • Clinique Médicale L'Actuel
      • Montreal, Quebec, Canada, H2X 2P4
        • Montreal Chest Institute/Royal Victoria Hospital
      • Sainte-Foy, Quebec, Canada, F1V 4G2
        • Centre Hospitalier de l'Université Laval (CHUL)
      • Ste-Foy, Quebec, Canada, G1V 4P9
        • Recherche Clinique Centre Medical Halles de Saint-
  • Estonia
      • Tallinn, Estonia, 10617
        • West-Tallinn Central Hospital
  • France
      • Annecy, France, 74011
        • CHU de la Region Annecienne
      • Bordeaux, France, 33076
        • Hopital Pellegrin
      • Chu-grenoble, France
        • Centre hospitalier universitaire
      • Colombes, France
        • Hôpital Louis Mourier
      • Marseille, France, 13009
        • Hôpital Sainte-Marguerite
      • Paris, France, 75651
        • Hôpital Pitie Salpétrière
      • Paris, France, 75010
        • Hôpital Saint-Louis
  • Germany
      • Essen, Germany, 45122
        • Klinik fur Dermatologie, Venerologie, Allergologie
      • Frankfort, Germany, 60590
        • Johann Wolfgang Goethe University Hospital
      • Heidelberg, Germany, D-69115
        • Klinikum der Ruprecht-Karis-Universitat (U. Hospital)
      • Zurich Ch-, Germany, 8091
        • University Hospital Zurich
  • Ireland
      • Dublin 8, Ireland
        • St. James Hospital
  • Israel
      • Tel Aviv, Israel, 64239
        • Ramathibodi hospital
  • Italy
      • Antella-Firenze, Italy, 50011
        • U.O. Malattie Infettive, H.S.Maria Annunziata
      • Asti, Italy, 14100
        • SOCDU Malattie Infettive Ospedale Civile Asti
      • Brescia, Italy, I-25125
        • Instituto de Malattie Infettive e Tropicali
      • Busto Arsizio (va), Italy, 21052
        • Malattie Infettive Busto
      • Modena, Italy, 41100
        • Università degli Studi di Modena e Reggio Emilia
      • Pavia, Italy, 27100
        • Clinica Malattie Infettive
      • Rome, Italy, 00149
        • I.R.C.C.S."L.Spallanzani"
      • Torino, Italy, 10149
        • University of Turin
      • Torrette Di Ancona, Italy, 71-60020
        • Servizio Regionale di Immunologia Clinica e Tipizz
      • Venice, Italy
        • S.S. Giovanni e Paolo Hospital
  • Japan
      • Tokyo, Japan, 162-8655
        • AIDS Medical Center, International Medical Center
      • Tokyo, Japan, 162-8655
        • International Medical Center of Japan
  • Lithuania
      • Vilnius, Lithuania, 03011
        • Lithuanian AIDS center
  • Luxembourg
      • Barble, Luxembourg, L-1210
        • Centre Hospitalier de Luxembourg
  • Martinique
      • Fort-de-france, Martinique, 97261
        • C.H.U. Fort-de-France
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hosp
      • Wellington, New Zealand
        • Wellington Hosp
  • Norway
      • Oslo, Norway, N-0407
        • Ullevål Hospital
  • Peru
      • Lima, Peru, 13
        • Hospital Nacional Guillermo Almenara Irigoyen
      • Lima, Peru, 11
        • Hospital Nacional Edgardo Rebagliati Martins
  • Poland
      • Koszarowa Str. 5, Poland
        • Wroclaw University School of Medicine
  • Puerto Rico
      • Curitiba, Puerto Rico, 80430-040
        • Instituto A. Z. de Pesquisa e Ensino
  • Spain
      • Barcelona, Spain, E08025
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spain, E-28006
        • Hospital Universitario De La Princesa
      • Madrid, Spain, E-28805
        • Hospital Universitario Príncipe de Asturias
      • Sevilla, Spain, 41013
        • Hospital U. Virgen del Rocio
      • Terrassa, Spain, 08221
        • Hospital Mútua de Terrassa
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
  • Switzerland
      • Basel Ch, Switzerland, 4031
        • University Hospital Basel
      • Bern, Switzerland, 3010
        • Poliklinik fur Infektiologie
      • La Chaux-de-Fonds, Switzerland, 2300
        • Hopital de la Ville
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Lugano, Switzerland, 6903
        • Ospedale Regionale di Lugano
  • Thailand
      • Chiang Mai, Thailand, 50120
        • Sanpatong Hospital
      • Nonthaburi 11000, Thailand
        • Bamrasnaradura Institute
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Hawthorn House, Birmingham Heartlands NHS Trust
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Carshalton, United Kingdom, SM5, 1AA
        • St. Helier Hospital
      • Carshalton, Surrey, United Kingdom, SM5, 1AA
        • St. Helier Hospital
      • Essex, United Kingdom, CO3 3NB
        • Essex County Hospital
      • Halifax, United Kingdom
        • Victoria General Hospital, Q.E. II Health Sciences
      • London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SE1 7EH
        • St. Thomas' Hospital
      • London, United Kingdom, E9 6SR
        • Homerton University Hospital NHS Foundation Trust
      • London, United Kingdom, EC1A 7BE
        • Barts and The London, NHS Trust
      • London, United Kingdom, NW10 7NS
        • Central Middlesex Hospital
      • London, United Kingdom, SE5 9RS
        • T1 Coleridge Unit, North Middlesex Hospital
      • London, United Kingdom, SE5 9RS
        • The Caldecot Centre, Kings College Hospital NHS Tr
      • London, United Kingdom, SW17 ORE
        • St. George's Hospital
      • London, United Kingdom, W1 2NY
        • St. Mary's Hospital
      • London, United Kingdom, WC1E 6AU
        • The Mortimer Market Center
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital
      • Middlesex, United Kingdom, UB1 3HW
        • Pasteur Suite, Ealing Hospital
      • Newcastle, United Kingdom, NE4 6BE
        • Newcastle General Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital
      • Watford Wd, United Kingdom, 18 0HB
        • Watford Sexual Health Center;Watford General Hosp
    • England
      • Oxford, England, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
  • United States
    • California
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont/Hayward Medical Centers
      • Los Angeles, California, United States, 90015
        • AIDS Healthcare Foundation
      • Los Angeles, California, United States, 90028
        • Los Angeles Gay and Lesbian Community Service Ctr
      • San Francisco, California, United States, 94110
        • Community Consortium / UCSF
      • San Francisco, California, United States, 94110
        • Dr. Shawn Hassler
      • San Francisco, California, United States, 94110
        • East Bay AIDS Ctr
      • San Francisco, California, United States, 94110
        • Lawrence Goldyn, MD
    • Colorado
      • Denver, Colorado, United States, 80204-4507
        • Drs. Lichtenstein & Greenberg
      • Denver, Colorado, United States, 80204-4507
        • Western Infectious Disease Consultants
      • Denver, Colorado, United States, 802044507
        • Denver CPCRA / Denver Public Hlth
      • Denver, Colorado, United States, 80204
        • McDowell Healthcare Center
    • Connecticut
      • New Haven, Connecticut, United States, 065102483
        • Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
      • New Haven, Connecticut, United States, 06510
        • Veterans Administration Medical Center
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • Christiana Care Health Services HIV Program George
    • District of Columbia
      • Washington, District of Columbia, United States, 204220001
        • Timothy A Price
      • Washington, District of Columbia, United States, 20422
        • George Washington Univ
      • Washington, District of Columbia, United States, 20422
        • Washington Reg AIDS Prog / Dept of Infect Dis
    • Florida
      • Miami, Florida, United States, 33125
        • Miami Veterans Affairs Med Ctr
      • Pensacola, Florida, United States, 32504
        • Center for Prevention and Treatment of Infections
      • Vero Beach, Florida, United States, 32960
        • Treasure Coast Infectious Disease Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Absolute Care Clinic
      • Atlanta, Georgia, United States, 30308
        • AID Atlanta/Morehouse Med School Ryan White Cl
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta (ARCA) Central
      • Atlanta, Georgia, United States, 30308
        • Cobb-Douglas County Infectious Disease Clinic
      • Atlanta, Georgia, United States, 30308
        • Dekalb County Health Dept Infectious Disease
      • Atlanta, Georgia, United States, 30308
        • Dr. Dennis Melton (private practice)
      • Atlanta, Georgia, United States, 30308
        • Dr. Melanie Thompson and Dr. Annette Bernard (private practice)
      • Atlanta, Georgia, United States, 30308
        • Dr. Richard Hudson (private practice)
    • Idaho
      • Boise, Idaho, United States, 83704
        • HIV Services Clinic/Family Practice Medical Center
    • Illinois
      • Chicago, Illinois, United States, 606576156
        • Cook County Hosp
      • Chicago, Illinois, United States, 606576156
        • Klein and Slotten Associates / AIDS Research Alliance
      • Chicago, Illinois, United States, 606576156
        • Lakeshore Infectious Disease Associates
      • Chicago, Illinois, United States, 606576156
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60657
        • AIDS Research Alliance - Chicago
      • Chicago, Illinois, United States, 60657
        • Northside Family Medicine
      • Chicago, Illinois, United States, 60657
        • Northwestern Memorial Physicians
      • Chicago, Illinois, United States, 60657
        • University of Chicago
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University (SIU) School of Medicine
    • Kansas
      • Wichita, Kansas, United States, 37214-3199
        • KU Medical School-Wichita, Midtown Clinic
      • Wichita, Kansas, United States, 37214-3199
        • KU Medical School-Wichita, MPA
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-2699
        • University of Mississippi Medical Center
      • New Orleans, Louisiana, United States, 701122699
        • Our Lady of the Lake Regional Med Ctr
      • New Orleans, Louisiana, United States, 70112
        • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Community Research Initiatives of New England
      • Boston, Massachusetts, United States, 02215
        • Community Research Initiatives/ProACT
      • Springfield, Massachusetts, United States, 01107
        • Community Research Initiative/ProACT
    • Michigan
      • Ann Arbor, Michigan, United States, 48100-0378
        • University of Michigan Health System
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Detroit, Michigan, United States, 48201
        • Detroit Community Health Connection
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ / Medical College of Ohio at Toledo
      • Detroit, Michigan, United States, 48202
        • Mt. Clemens General Hospital
      • Detroit, Michigan, United States, 48202
        • Providence Hosp- Newland Med Assoc. Inc.
      • Grand Rapids, Michigan, United States, 49503
        • McAuley Health Center
      • Lansing, Michigan, United States, 48910
        • Michigan State University Infectious Diseases Clinic
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital/CORNET
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic/CORNET
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital Early Intervention Program
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore Med Ctr
      • Newark, New Jersey, United States, 07103
        • Jeffrey Bomser Clinic / NJCR
      • Newark, New Jersey, United States, 071032842
        • Raritan Bay Med Ctr
      • Newark, New Jersey, United States, 071032842
        • Saint Michael's Med Ctr
      • Newark, New Jersey, United States, 07103
        • New Jersey Community Research Initiative
      • Newark, New Jersey, United States, 07103
        • NJCRI
      • Somers Poinnt, New Jersey, United States, 08244
        • South Jersey Infectious Disease
    • New York
      • Bronx, New York, United States, 10453
        • Bronx-Lebanon Hosp Ctr
      • Bronx, New York, United States, 10468
        • Bronx Veterans Affairs Medical Center
      • Brooklyn, New York, United States, 11023
        • SUNY Downstate Med Ctr
      • New York, New York, United States, 10037
        • Grant Houses Health Ctr
      • New York, New York, United States, 10037
        • HHC MMC Unit #1
      • New York, New York, United States, 10037
        • HHC Outpatient Clinics
      • New York, New York, United States, 10037
        • Jacobi Medical Center
      • New York, New York, United States, 10037
        • Lenox Avenue Health Ctr
      • New York, New York, United States, 10037
        • Lincoln Medical & Mental Health Center
      • New York, New York, United States, 10037
        • Polo Grounds Health Care Ctr
      • New York, New York, United States, 10037
        • Syndenham Neighborhood Family Care Ctr
      • New York, New York, United States, 10039
        • Metropolitan Hospital Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1042
        • Wake Forest Univ Health Sciences
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Univ of Oklahoma Health Sciences
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
      • Portland, Oregon, United States, 97209-2534
        • Legacy Clinic NE
      • Portland, Oregon, United States, 97209-2534
        • Salem Hospital
      • Portland, Oregon, United States, 972105311
        • The Research & Education Group / Multomah Cnty Hlth Dept
      • Portland, Oregon, United States, 972105311
        • The Research & Education Group / The R & E Grp Office
      • Portland, Oregon, United States, 972105311
        • The Research & Education Grp / Oregon Hlth Sci Univ
      • Portland, Oregon, United States, 972105311
        • The Rsch & Ed Grp / Legacy Cln at Good Samaritan
      • Portland, Oregon, United States, 972105311
        • The Rsch & Ed Grp / Providence Portland Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
      • Philadelphia, Pennsylvania, United States, 19107
        • Penn Community Infectious Diseases
      • Philadelphia, Pennsylvania, United States, 19140
        • Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple Univ School of Medicine
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Veterans Administration Med Ctr
      • Houston, Texas, United States, 77006
        • Montrose Clinic
      • Houston, Texas, United States, 77030
        • Univ TX Health Science Ctr
      • Houston, Texas, United States, 77030
        • University Clinical Research Center
      • San Antonio, Texas, United States, 78229
        • South Texas Veterans Health Care System
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Infectious Disease Associates of Virginia
      • Richmond, Virginia, United States, 232980049
        • Cross Over Clinic / Div of Infectious Diseases
      • Richmond, Virginia, United States, 232980049
        • McGuire VA / Division of Infectious Diseases
      • Richmond, Virginia, United States, 23298
        • MCV ID Clinic
      • Richmond, Virginia, United States, 23298
        • MediCorp, Infectious Disease Associates
      • Richmond, Virginia, United States, 23298
        • Petersburg Health Care Alliance
      • Richmond, Virginia, United States, 23298
        • South Richmond Health Ctr
      • Richmond, Virginia, United States, 23298
        • Vernon J. Harris East End Community Health Care Ct
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Note: Enrollment into this trial was halted 01/11/06.

Inclusion Criteria:

  • HIV infection
  • CD4 cell count greater than 350 cells/mm3 within 45 days of study entry
  • Willing to start, change, or stop antiretroviral therapy
  • Acceptable methods of contraception
  • Good health at the time of study entry
  • Available for the study for at least 6 months
  • Able, in the clinician's opinion, to comply with the protocol

Exclusion Criteria:

  • Currently participating in the MDR-HIV, NvR study, or another study which is not consistent with one of the treatment groups in this study. CPCRA FIRST participants may be screened for SMART after August 8, 2005 and can be randomized into SMART on or after September 19, 2005.
  • Pregnant or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Wafaa El-Sadr, MD, MPH, Harlem AIDS Treatment Group, Harlem Hospital Center
  • Study Chair: James Neaton, PhD, CPCRA Statistcal and Data Management Center / CCBR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 4, 2001

First Submitted That Met QC Criteria

December 4, 2001

First Posted (Estimate)

December 5, 2001

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 24, 2009

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPCRA 065
  • SMART

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe