A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected With HIV-1

September 11, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Evaluation of Virologic, Immunologic, and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1

The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.

Patients who receive HIV vaccines are sometimes protected from HIV infection. More often, these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.

Study Overview

Status

Completed

Conditions

Detailed Description

There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing immunity). However, current viral vaccines are thought to limit, but not prevent, virus replication after infection. In the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection.

Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study. Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. Study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.

Study Type

Observational

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

  • United States
    • California
      • San Francisco, California, United States, 94102
        • San Francisco Dept of Hlth / AIDS Office
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Dept of Public Health / HIVNET
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois Chicago / Howard Brown Hlth Ctr
      • Chicago, Illinois, United States, 60657
        • Howard Brown Health Ctr / HIVNET
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Fenway Community Health Ctr / HIVNET
    • New York
      • Bronx, New York, United States, 10456
        • New York Blood Ctr
      • New York, New York, United States, 10016
        • New York Univ Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania / HIVNET
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Mem Hosp of Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Become infected with HIV while participating in HIVNET 014, or if they are an HIV-positive partner (sexual or needle-sharing) of a HIVNET 014A participant.
  • Are able and willing to provide written informed consent.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have a serious psychiatric or psychological disorder that would prevent them from completing the study.

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)

Investigators

  • Study Chair: Connie Celum
  • Study Chair: Susan Buchbinder
  • Study Chair: Haynes Sheppard

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

August 1, 1999

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

September 12, 2008

Last Update Submitted That Met QC Criteria

September 11, 2008

Last Verified

June 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIVNET 014A

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.

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