Clinical trial NCT00086372: Long-term Follow-up of HIV Infected Patients Identified During Early Infection
Official title: Acute HIV Infection and Early Disease Research Program (AIEDRP) CORE01 Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Acute Infection
Treatment Experienced
Treatment Naive
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
name: Acute Infection and Early Disease Research Program
First posted: 2004-07-01
Enrollment: 157
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility 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
* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
city: Springfield
country: United States
facility: Community Research Initiative of New England-Sprin
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University (St. Louis)
state: Missouri
city: Brooklyn
country: United States
facility: State University of NY Downstate
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Aaron Diamond AIDS Research Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: Community Health Network, Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Presbyterian Medical Center - Univ. of PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania, Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Darlinghurst
country: Australia
facility: University of New South Wales
state: New South Wales
city: St. Kilda
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: St. Kilda
country: Australia
facility: The Centre Clinic
state: Victoria
city: Carlton VID
country: Australia
facility: Carlton Clinic
city: Salvador
country: Brazil
facility: Centro de Referencia Estadual de AIDS (CREAIDS)
state: Bahia
city: Vancouver
country: Canada
facility: University of British Columbia, Vancouver, BC
state: British Columbia
city: Montreal
country: Canada
facility: Montreal Chest Institute of the McGill University
state: Quebec
city: Harare
country: Zimbabwe
facility: University of Zimbabwe Clinical Research Centre
Study officials:
affiliation: Aaron Diamond AIDS Research Center, Rockefeller University
name: Martin Markowitz, MD
role: STUDY_CHAIR
affiliation: University of California, San Diego
name: Susan Little, MD
role: STUDY_CHAIR
References:
citation: 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.
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. doi: 10.1172/JCI21540.
citation: 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.