Long-term Follow-up of HIV Infected Patients Identified During Early Infection
NCT ID: NCT00086372
Last Updated: 2012-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
157 participants
OBSERVATIONAL
2003-07-31
2007-04-30
Brief Summary
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Detailed Description
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This database study will establish a cohort of HIV infected individuals who are participating in HIV studies at AIEDRP sites and of HIV infected individuals who have chosen to defer therapy but agree to be followed by this study. The study will facilitate longitudinal and prospectively planned meta-analyses or cross-protocol analyses of AIEDRP studies by developing data collection guidelines, defining common research goals, and creating data templates. The primary aim is to determine the long-term virologic, immunologic, and clinical outcomes and complications for patients who were diagnosed during acute or early HIV infection.
Participants in this study will be followed for at least 5 years. Study visits will occur at Weeks 2, 4, and 12, and then every 12 weeks thereafter, through Week 96. After 2 years, study visits will occur every 24 weeks until the end of the study. Participants who start antiretroviral therapy at or after Week 2 will restart the study visit schedule. Study visits will include a medical interview, adherence questionnaire, and blood tests. Duplicate tests performed as part of another study will not be performed if the results of those tests are available.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* Willing to allow study investigators access to and use of participant's medical information from other AIEDRP clinical trials
* Parent or guardian willing to provide informed consent, if applicable
* If enrolled at an AIDS Clinical Trial Group (ACTG) site, must also be participating in one of the following clinical trials: AIN501/ACTG A5216, AIN503/ACTG A5217, or AIN504/ACTG A5218
Exclusion Criteria
* Any factor that, in the opinion of the study official, may interfere with study participation
13 Years
ALL
No
Sponsors
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Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Acute Infection and Early Disease Research Program
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Martin Markowitz, MD
Role: STUDY_CHAIR
Aaron Diamond AIDS Research Center, Rockefeller University
Susan Little, MD
Role: STUDY_CHAIR
University of California, San Diego
Locations
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University of Alabama - Birmingham
Birmingham, Alabama, United States
Cedars-Sinai
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Fenway Community Health
Boston, Massachusetts, United States
Community Research Initiative of New England-Sprin
Springfield, Massachusetts, United States
Washington University (St. Louis)
St Louis, Missouri, United States
State University of NY Downstate
Brooklyn, New York, United States
Beth Israel Medical Center
New York, New York, United States
Aaron Diamond AIDS Research Center
New York, New York, United States
Columbia University
New York, New York, United States
Community Health Network, Inc.
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Presbyterian Medical Center - Univ. of PA
Philadelphia, Pennsylvania, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of New South Wales
Darlinghurst, New South Wales, Australia
Prahran Market Clinic
St Kilda, Victoria, Australia
The Centre Clinic
St Kilda, Victoria, Australia
Carlton Clinic
Carlton VID, , Australia
Centro de Referencia Estadual de AIDS (CREAIDS)
Salvador, Estado de Bahia, Brazil
University of British Columbia, Vancouver, BC
Vancouver, British Columbia, Canada
Montreal Chest Institute of the McGill University
Montreal, Quebec, Canada
University of Zimbabwe Clinical Research Centre
Harare, , Zimbabwe
Countries
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References
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Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. doi: 10.1086/420745. Epub 2004 Apr 30.
Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540.
Falster K, Gelgor L, Shaik A, Zablotska I, Prestage G, Grierson J, Thorpe R, Pitts M, Anderson J, Chuah J, Mulhall B, Petoumenos K, Kelleher A, Law M. Trends in antiretroviral treatment use and treatment response in three Australian states in the first decade of combination antiretroviral treatment. Sex Health. 2008 Jun;5(2):141-54. doi: 10.1071/sh07082.
Other Identifiers
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ACTG A5228
Identifier Type: -
Identifier Source: secondary_id
AIEDRP CORE01
Identifier Type: -
Identifier Source: org_study_id