An observational study in HIV Infection, sponsored by University of North Carolina, Chapel Hill. Completed at 10 sites in United States. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by University of North Carolina, Chapel Hill · Observational
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.
4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 113 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who were identified as HLA Class I HLA-B*27, B*35, B*53, and/or B*57 positive from the REACH study will be contacted for their interest in participating in this study. Only former REACH sites in the ATN will be eligible to enroll subjects into this study.
Exclusion Criteria:
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
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
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill