Evaluation of Genetic Markers as Explanations for the Observed Differences in Disease Progression in HIV+ Youth
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ClinicalTrials.gov Identifier: NCT00107029 |
Recruitment Status
:
Completed
First Posted
: April 5, 2005
Last Update Posted
: February 28, 2017
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Tracking Information | ||||
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First Submitted Date | April 4, 2005 | |||
First Posted Date | April 5, 2005 | |||
Last Update Posted Date | February 28, 2017 | |||
Study Start Date | December 2002 | |||
Actual Primary Completion Date | September 2005 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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 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.
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Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00107029 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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 ] 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.
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Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Evaluation of Genetic Markers as Explanations for the Observed Differences in Disease Progression in HIV+ Youth | |||
Official Title | Evaluation of HIV-Specific CD8+ T-Cell Responses and Escape Mutations as Explanations for the Observed Differences in Disease Progression Conferred by HLA Class I Alleles | |||
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. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Other |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Biomedical HIV-1 related data and samples are available for the time the subjects were enrolled in REACH. HIV-1 genotyping will certainly be possible from these retrospective samples and the stored PBMCs will be evaluated for usefulness in the HIV-1 specific assays. Prospectively, samples will be collected every six months over a two-year period to evaluate both HIV-1 specific CD8+ T cell responses and the dominant HIV-1 genotype longitudinally. |
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Sampling Method | Non-Probability Sample | |||
Study Population | 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. | |||
Condition | HIV Infection | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
113 | |||
Original Enrollment | Same as current | |||
Actual Study Completion Date | September 2005 | |||
Actual Primary Completion Date | September 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00107029 | |||
Other Study ID Numbers | ATN 026 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of North Carolina, Chapel Hill | |||
Study Sponsor | University of North Carolina, Chapel Hill | |||
Collaborators |
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Investigators |
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PRS Account | University of North Carolina, Chapel Hill | |||
Verification Date | February 2016 |