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

University of North Carolina, Chapel Hill113 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

113

Conditions

HIV Infection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (10)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, United States

Outcomes

Primary Outcomes

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.

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.

Time frame: 96 Weeks

Secondary Outcomes

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.

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.

Time frame: 96 Weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.