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

Completed

• Conditions: HIV Infection

• Registration Number: NCT00107029
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-04-04
• Study First Submitted QC: 2005-04-04
• Study First Posted: 2005-04-05
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2016-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate that few CTL escape mutations occur in HIV-1 specific CD8+ T cell epitopes that are HLA-B*27 and B*57 restricted, when compared to those restricted by HLA-B*35 and B*53.	96 Weeks	Demonstrate that few CTL escape mutations occur in HIV-1 specific CD8+ T cell epitopes that are HLA-B\*27 and B\*57 restricted, when compared to those restricted by HLA-B\*35 and B\*53.

Secondary Outcome Measures

Name	Time	Method
Demonstrate that CD8+ T cells have a high functional avidity to HLA-B*27 and B*57 bound epitopes when compared to those responding to HLA-B*35 and B*53 bound epitopes.	96 Weeks	Demonstrate that CD8+ T cells have a high functional avidity to HLA-B\*27 and B\*57 bound epitopes when compared to those responding to HLA-B\*35 and B\*53 bound epitopes.

Trial Locations

Locations (10)

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Children's Diagnostic and Treatment Center; 🇺🇸 Ft. Lauderdale, Florida, United States

University of Miami-Jackson Memorial Medical Center; 🇺🇸 Miami, Florida, United States

Cook County Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Tulane Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital at Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States