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).

Condition
HIV Infections

Further Study Details: 

Expected Total Enrollment:  2200

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 and/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 are scheduled at Weeks 2, 4, 12, and then every 12 weeks for 3 years. After 3 years, study visits are scheduled every 24 weeks until the end of the study. Participants who start antiretroviral therapy at or after the Week 2 study visit will restart the study visit schedule. Study visits will include a medical interview, adherence questionnaire, and blood tests. Tests that duplicate tests performed as part of another study will not be performed if the results of those tests are available.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Documented acute or recent HIV infection
• Willing to allow study investigators access to and use of participant’s medical information from other AIEDRP clinical trials

Exclusion Criteria

• More than 7 days of antiretroviral therapy prior to study entry without adequate documentation of pretreatment viral load and CD4 count. Persons who have failed post-exposure prophylaxis with antiretroviral treatment are not excluded from enrollment.
• Any factor that, in the opinion of the study official, could prevent compliance with study requirements

California
      Cedars-Sinai Medical Center, Torrance,  California,  90502,  United States; Recruiting
Massachusetts
      Community Research Initiative of New England-Sprin, Springfield,  Massachusetts,  01107,  United States; Recruiting
Australia
      Carlton Clilnic, Carlton VID,  3053,  Australia; Recruiting
Australia, Victoria
      The Centre Clinic, St. Kilda,  Victoria,  3182,  Australia; Recruiting
      Prahran Market Clinic, St. Kilda,  Victoria,  3182,  Australia; Recruiting
Brazil, Bahia
      Centro de Referencia Estadual de AIDS (CREAIDS), Salvador,  Bahia,  40110-160,  Brazil; Recruiting
Canada, British Columbia
      University of British Columbia, Vancouver, BC, Vancouver,  British Columbia,  V6Z 2C7,  Canada; Recruiting

Study chairs or principal investigators

Martin Markowitz, MD,  Study Chair,  Aaron Diamond AIDS Research Center, Rockefeller University   
Susan Little, MD,  Study Chair,  University of California at San Diego   

Study ID Numbers:  AIEDRP CORE01
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  June 30, 2004
ClinicalTrials.gov Identifier:  NCT00086372
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08