Evaluation of Genetic Markers as Explanations for the Observed Differences in Disease Progression in HIV+ Youth
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
1 other identifier
observational
113
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2002
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 4, 2005
CompletedFirst Posted
Study publicly available on registry
April 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFebruary 28, 2017
February 1, 2016
2.8 years
April 4, 2005
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
96 Weeks
Secondary Outcomes (1)
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.
96 Weeks
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33101, United States
University of Miami-Jackson Memorial Medical Center
Miami, Florida, 33101, United States
Cook County Children's Hospital
Chicago, Illinois, 60612, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Mount Sinai Medical Center
New York, New York, 10128, United States
Children's Hospital at Montefiore Medical Center
The Bronx, New York, 10467, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Links
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul Goepfert, MD
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2005
First Posted
April 5, 2005
Study Start
December 1, 2002
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
February 28, 2017
Record last verified: 2016-02