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NCT00086372 Clinical Trial

Long-term Follow-up of HIV Infected Patients Identified During Early Infection

HIV Infections Clinical Trial

Official title:
Acute HIV Infection and Early Disease Research Program (AIEDRP) CORE01 Database

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00086372
Other study ID # AIEDRP CORE01
Secondary ID ACTG A5228
Status Completed
Phase N/A
First received June 30, 2004
Last updated October 26, 2012
Start date July 2003
Est. completion date April 2007

Study information
Verified date October 2012
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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).

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 information / eligibility
Status Completed
Enrollment 157
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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

- 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

- More than 7 days of antiretroviral therapy prior to study entry without adequate documentation of pretreatment viral load and CD4 count. Individuals who have failed postexposure prophylaxis with antiretroviral treatment are not excluded from enrollment.

- Any factor that, in the opinion of the study official, may interfere with study participation

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Carlton Clinic Carlton VID
Australia University of New South Wales Darlinghurst New South Wales
Australia Prahran Market Clinic St. Kilda Victoria
Australia The Centre Clinic St. Kilda Victoria
Brazil Centro de Referencia Estadual de AIDS (CREAIDS) Salvador Bahia
Canada Montreal Chest Institute of the McGill University Montreal Quebec
Canada University of British Columbia, Vancouver, BC Vancouver British Columbia
United States Johns Hopkins University Baltimore Maryland
United States University of Alabama - Birmingham Birmingham Alabama
United States Fenway Community Health Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States State University of NY Downstate Brooklyn New York
United States University of North Carolina, Chapel Hill Chapel Hill North Carolina
United States University of Colorado Health Sciences Center Denver Colorado
United States Duke University Durham North Carolina
United States Cedars-Sinai Los Angeles California
United States Vanderbilt University Nashville Tennessee
United States Aaron Diamond AIDS Research Center New York New York
United States Beth Israel Medical Center New York New York
United States Columbia University New York New York
United States Presbyterian Medical Center - Univ. of PA Philadelphia Pennsylvania
United States University of Pennsylvania, Philadelphia Philadelphia Pennsylvania
United States Community Health Network, Inc. Rochester New York
United States University of Rochester Medical Center Rochester New York
United States University of California, San Diego San Diego California
United States University of California, San Francisco San Francisco California
United States Community Research Initiative of New England-Sprin Springfield Massachusetts
United States Washington University (St. Louis) St. Louis Missouri
United States Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Torrance California
Zimbabwe University of Zimbabwe Clinical Research Centre Harare

Sponsors (3)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Acute Infection and Early Disease Research Program, AIDS Clinical Trials Group

Countries where clinical trial is conducted

United States,  Zimbabwe,  Australia,  Brazil,  Canada, 

References & Publications (3)

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 de — View Citation

Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. Epub 2004 Apr 30. — View Citation

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. Review. Erratum in: J Clin Invest. 2006 Dec;116(12):3292. — View Citation

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