Evaluation of Genetic Markers as Explanations for the Observed Differences in Disease Progression in HIV+ Youth

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

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-09-30

Brief Summary

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This protocol is a study of HIV+ young people who were identified as having certain HIV-1 specific T-cell responses and genetic markers while previously enrolled in the 5-year longitudinal adolescent study, "REACH." Blood samples will be collected, a medical and medication history and physical examination will be performed every 6 months for a total of 2 years.

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Detailed Description

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Numerous studies have demonstrated an association between HLA class I genotypes with differing progression to AIDS in individuals who are followed after being off antiretroviral therapy. These studies do not always associate the same HLA class I alleles with the risks of HIV-1 disease progression; however they consistently demonstrated that HLA-B\*35 and B\*53 portend a bad outcome compared to the better outcome observed in HLA-B\*27 and B\*57 carriers. Despite this information, very little data exists to explain the mechanism of this association.

This longitudinal study will look at the HIV-1 specific CD8+ T-cell responses and the dominant HIV-1 genotype among individuals identified as HLA-B\*27, B\*35, B\*53 and B\*57 positive through studies done in collaboration with the REACH project.

Conditions

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HIV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* HLA-Class I HLA-B\*27, B\*35, B\*53 and/or B\*57 positive identified through the REACH study
* Subject's ability and willingness to provide written informed consent
* Subject's ability and willingness to be followed at least one year on this ATN 026 study

Exclusion Criteria

* On chronic immunosuppressive therapy, not including topical or inhaled steroid use.
* Any prohibited medication listed in protocol within 2 weeks prior to the Entry visit labs

Eligible Sex

ALL

Accepts Healthy Volunteers

No