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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107029
• Other study ID #: ATN 026
• Status: Completed
• Phase: N/A
• First received: April 4, 2005
• Last updated: February 27, 2017
• Start date: December 2002
• Est. completion date: September 2005

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Children's Hospital at Montefiore Medical Center	Bronx	New York
United States	Cook County Children's Hospital	Chicago	Illinois
United States	Children's Diagnostic and Treatment Center	Ft. Lauderdale	Florida
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Miami-Jackson Memorial Medical Center	Miami	Florida
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	96 Weeks

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions