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NCT00001121 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001121
Other study ID # HIVNET 014A
Secondary ID
Status Completed
Phase N/A
First received November 2, 1999
Last updated September 11, 2008
Start date August 1999

Study information
Verified date June 2003
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

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States Fenway Community Health Ctr / HIVNET Boston Massachusetts
United States New York Blood Ctr Bronx New York
United States Howard Brown Health Ctr / HIVNET Chicago Illinois
United States Univ of Illinois Chicago / Howard Brown Hlth Ctr Chicago Illinois
United States Denver Dept of Public Health / HIVNET Denver Colorado
United States New York Univ Med Ctr New York New York
United States Mem Hosp of Rhode Island Pawtucket Rhode Island
United States Univ of Pennsylvania / HIVNET Philadelphia Pennsylvania
United States Miriam Hosp Providence Rhode Island
United States San Francisco Dept of Hlth / AIDS Office San Francisco California
United States Univ of Washington Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

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