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

This study has been completed.

Sponsors and Collaborators: National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00107029
  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

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
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

Further study details as provided by National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:   113
Study Start Date:   December 2002
Estimated Study Completion Date:   September 2005

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107029

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

Sponsors and Collaborators

Investigators
Study Chair:     Paul Goepfert, MD     University of Alabama at Birmingham    
  More Information


Website for the Adolescent Trials Network for HIV/AIDS Interventions  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   ATN 026
First Received:   April 4, 2005
Last Updated:   April 2, 2007
ClinicalTrials.gov Identifier:   NCT00107029
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Child Health and Human Development (NICHD):
HIV infection  
CD8+ T-cells  
HIV-1 genotype  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Disease Progression
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Disease Attributes
RNA Virus Infections
Pathologic Processes
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on September 23, 2008




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