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

Tracking Information
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; (submitted: September 5, 2011)	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.
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; (submitted: September 5, 2011)	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.
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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Other
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.
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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: June 23, 2005)	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: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
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	National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH); National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators	Study Chair: Paul Goepfert, MD University of Alabama at Birmingham
PRS Account	University of North Carolina, Chapel Hill
Verification Date	February 2016