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

October 26, 2012 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Carlton VID, Australia, 3053
        • Carlton Clinic
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • University of New South Wales
    • Victoria
      • St. Kilda, Victoria, Australia, 3182
        • Prahran Market Clinic
      • St. Kilda, Victoria, Australia, 3182
        • The Centre Clinic
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40110-160
        • Centro de Referencia Estadual de AIDS (CREAIDS)
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • University of British Columbia, Vancouver, BC
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T7
        • Montreal Chest Institute of the McGill University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama - Birmingham
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai
      • San Diego, California, United States, 92103
        • University of California, San Diego
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Fenway Community Health
      • Springfield, Massachusetts, United States, 01107
        • Community Research Initiative of New England-Sprin
    • Missouri
      • St. Louis, Missouri, United States, 63108-2138
        • Washington University (St. Louis)
    • New York
      • Brooklyn, New York, United States, 11203
        • State University of NY Downstate
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10027
        • Columbia University
      • New York, New York, United States, 10016
        • Aaron Diamond AIDS Research Center
      • Rochester, New York, United States, 14642-0001
        • Community Health Network, Inc.
      • Rochester, New York, United States, 14642-0001
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7215
        • University of North Carolina, Chapel Hill
      • Durham, North Carolina, United States, 27701
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • Presbyterian Medical Center - Univ. of PA
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University
  • Zimbabwe
      • Harare, Zimbabwe
        • University of Zimbabwe Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

AIDS Clinical Trials Group
Acute Infection and Early Disease Research Program

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 30, 2004

First Submitted That Met QC Criteria

June 30, 2004

First Posted (Estimate)

July 1, 2004

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIEDRP CORE01
  • ACTG A5228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe