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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00340223
Other study ID # 999905237
Secondary ID 05-C-N237
Status Withdrawn
Phase N/A
First received June 19, 2006
Last updated May 9, 2012
Start date September 2005
Est. completion date September 2007

Study information

Verified date May 2012
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility - INCLUSION AND 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.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States John Hopkins Bloomberg School of Public Health Baltimore Maryland
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland
United States Howard Brown Health Center Chicago Illinois
United States John H. Stroger, Jr. Hospital of Cook County Chicago Illinois
United States Northwestern University Chicago Illinois
United States University of California, Los Angeles Los Angeles California
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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