Evaluation of Genetic Markers as Explanations for the Observed Differences in Disease Progression in HIV+ Youth
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
HIV Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| 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 |
- 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 ] [ Designated as safety issue: No ]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 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 ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
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.
| Enrollment: | 113 |
| Study Start Date: | December 2002 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| United States, California | |
| Children's Hospital of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Children's Diagnostic and Treatment Center | |
| Ft. Lauderdale, Florida, United States, 33101 | |
| University of Miami-Jackson Memorial Medical Center | |
| Miami, Florida, United States, 33101 | |
| United States, Illinois | |
| Cook County Children's Hospital | |
| Chicago, Illinois, United States, 60612 | |
| United States, Louisiana | |
| Tulane Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, New York | |
| Children's Hospital at Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10128 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Chair: | Paul Goepfert, MD | University of Alabama at Birmingham |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00107029 History of Changes |
| Other Study ID Numbers: | ATN 026 |
| Study First Received: | April 4, 2005 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
HIV infection CD8+ T-cells HIV-1 genotype |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Disease Progression Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013