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

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ClinicalTrials.gov Identifier: NCT00086372
Recruitment Status : Completed
First Posted : July 1, 2004
Last Update Posted : October 29, 2012
Information provided by (Responsible Party):

Study Description
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).

Condition or disease
HIV Infections

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.

Study Design

Study Type : Observational
Actual Enrollment : 157 participants
Official Title: Acute HIV Infection and Early Disease Research Program (AIEDRP) CORE01 Database
Study Start Date : July 2003
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086372

  Show 30 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
AIDS Clinical Trials Group
Acute Infection and Early Disease Research Program
Study Chair: Martin Markowitz, MD Aaron Diamond AIDS Research Center, Rockefeller University
Study Chair: Susan Little, MD University of California, San Diego
More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00086372     History of Changes
Other Study ID Numbers: AIEDRP CORE01
ACTG A5228
First Posted: July 1, 2004    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acute Infection
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases