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

NCT ID: NCT00001121

Last Updated: 2008-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1999-08-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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Placebos AIDS Vaccines Follow-Up Studies HIV Therapeutic Vaccine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Connie Celum

Role: STUDY_CHAIR

Susan Buchbinder

Role: STUDY_CHAIR

Haynes Sheppard

Role: STUDY_CHAIR

Locations

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San Francisco Dept of Hlth / AIDS Office

San Francisco, California, United States

Site Status

Denver Dept of Public Health / HIVNET

Denver, Colorado, United States

Site Status

Univ of Illinois Chicago / Howard Brown Hlth Ctr

Chicago, Illinois, United States

Site Status

Howard Brown Health Ctr / HIVNET

Chicago, Illinois, United States

Site Status

Fenway Community Health Ctr / HIVNET

Boston, Massachusetts, United States

Site Status

New York Univ Med Ctr

New York, New York, United States

Site Status

New York Blood Ctr

The Bronx, New York, United States

Site Status

Univ of Pennsylvania / HIVNET

Philadelphia, Pennsylvania, United States

Site Status

Mem Hosp of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

Miriam Hosp

Providence, Rhode Island, United States

Site Status

Univ of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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HIVNET 014A

Identifier Type: -

Identifier Source: org_study_id