HLA-B35 Alleles and AIDS

NCT ID: NCT00340223

Last Updated: 2012-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

Brief Summary

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This study will identify variations in the genome of the human immunodeficiency virus (HIV) early after infection and following the development of AIDS. It will analyze genetic material and clinical data from HIV-positive individuals to assess differences in viral epitopes between patients with two different gene alleles (alternative forms of a gene)-B\*3501 and B\*3503. (An epitope is a molecular region on the surface of an antigen capable of eliciting an immune response and of combining with the specific antibody produced by such a response.)

HIV disease in people with the B\*3503 allele progresses significantly faster than it does in people with the B\*3501 allele. This study might provide information that is potentially useful in developing a successful HIV vaccine.

Blood samples and clinical data for analysis will be obtained from the Johns Hopkins Bloomberg School of Public Health; the University of Pittsburgh; the John H. Stroger, Jr. Hospital of Cook County; the Howard Brown Health Center; Northwestern University; and the University of California at Los Angeles.

Detailed Description

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The purpose of this study is to identify variations in the genome of HIV early after infection and following the development of AIDS to determine the location of escape mutations that might provide information about potential B\*35 epitopes. These data will be useful in explaining the difference in disease progression between individuals possessing B\*35 Px alleles and those with B\*35 PY alleles. We have previously shown that individuals with B\*35 Px alleles progress at a significantly faster rate compared to those with B\*35 PY alleles. This study might provide information which is potentially useful in the development of a successful HIV vaccine.

Conditions

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HIV-1 AIDS

Eligibility Criteria

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Exclusion Criteria

Sera and relevant clinical data from properly consented HIV positive seroconverters will be provided to the LGD for analysis. No available subjects will be excluded to maximize power. We will request an accrual ceiling of 100 participants.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Howard Brown Health Center

Chicago, Illinois, United States

Site Status

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

John Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Site Status

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Kiepiela P, Leslie AJ, Honeyborne I, Ramduth D, Thobakgale C, Chetty S, Rathnavalu P, Moore C, Pfafferott KJ, Hilton L, Zimbwa P, Moore S, Allen T, Brander C, Addo MM, Altfeld M, James I, Mallal S, Bunce M, Barber LD, Szinger J, Day C, Klenerman P, Mullins J, Korber B, Coovadia HM, Walker BD, Goulder PJ. Dominant influence of HLA-B in mediating the potential co-evolution of HIV and HLA. Nature. 2004 Dec 9;432(7018):769-75. doi: 10.1038/nature03113.

Reference Type BACKGROUND
PMID: 15592417 (View on PubMed)

Other Identifiers

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05-C-N237

Identifier Type: -

Identifier Source: secondary_id

999905237

Identifier Type: -

Identifier Source: org_study_id

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