Long-term Follow-up of HIV Infected Patients Identified During Early Infection
- Conditions
- HIV Infections
- Registration Number
- NCT00086372
- Brief Summary
This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP).
- Detailed Description
AIEDRP was established to develop and evaluate data from studies of patients with acute or recent HIV infection. Long-term effects of antiretroviral therapies raise questions regarding the value and necessity of therapeutic interventions during acute and early HIV infection. Conventional randomized clinical trials are generally designed with finite endpoints; most patients who reach an endpoint or complete a protocol are no longer followed. As a result, long-term virologic, immunologic, and clinical outcome data are not available. This is particularly true for participants who fail therapy, require changes in treatment, or develop a treatment-limiting toxicity in a time-limited study.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania, Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Fenway Community Health
🇺🇸Boston, Massachusetts, United States
Centro de Referencia Estadual de AIDS (CREAIDS)
🇧🇷Salvador, Bahia, Brazil
Carlton Clinic
🇦🇺Carlton VID, Australia
University of Zimbabwe Clinical Research Centre
🇿🇼Harare, Zimbabwe
The Centre Clinic
🇦🇺St. Kilda, Victoria, Australia
Prahran Market Clinic
🇦🇺St. Kilda, Victoria, Australia
University of New South Wales
🇦🇺Darlinghurst, New South Wales, Australia
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Cedars-Sinai
🇺🇸Los Angeles, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Community Health Network, Inc.
🇺🇸Rochester, New York, United States
Community Research Initiative of New England-Sprin
🇺🇸Springfield, Massachusetts, United States
Columbia University
🇺🇸New York, New York, 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
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Presbyterian Medical Center - Univ. of PA
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Montreal Chest Institute of the McGill University
🇨🇦Montreal, Quebec, Canada
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Duke University
🇺🇸Durham, North Carolina, United States
Washington University (St. Louis)
🇺🇸St. Louis, Missouri, United States
University of British Columbia, Vancouver, BC
🇨🇦Vancouver, British Columbia, Canada
University of Rochester Medical Center
🇺🇸Rochester, New York, United States