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

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00107029

ATN 026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Volunteers: No Healthy Volunteers

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