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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00001121
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

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 Timeline

• Study Start: 1999-08
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2003-06
• Last Update Submitted: 2008-09-11
• Last Update Posted: 2008-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

Howard Brown Health Ctr / HIVNET; 🇺🇸 Chicago, Illinois, United States

Fenway Community Health Ctr / HIVNET; 🇺🇸 Boston, Massachusetts, United States

Miriam Hosp; 🇺🇸 Providence, Rhode Island, United States

New York Univ Med Ctr; 🇺🇸 New York, New York, United States

San Francisco Dept of Hlth / AIDS Office; 🇺🇸 San Francisco, California, United States

Mem Hosp of Rhode Island; 🇺🇸 Pawtucket, Rhode Island, United States

Univ of Illinois Chicago / Howard Brown Hlth Ctr; 🇺🇸 Chicago, Illinois, United States

Univ of Washington; 🇺🇸 Seattle, Washington, United States

Denver Dept of Public Health / HIVNET; 🇺🇸 Denver, Colorado, United States

Univ of Pennsylvania / HIVNET; 🇺🇸 Philadelphia, Pennsylvania, United States

New York Blood Ctr; 🇺🇸 Bronx, New York, United States