HLA-B35 Alleles and AIDS
| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 19, 2006 |
| Last Updated Date | May 9, 2012 |
| Start Date ICMJE | September 2005 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00340223 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | HLA-B35 Alleles and AIDS |
| Official Title ICMJE | Comparison of HIV-1 Epitopes That May be Recognized by HLA-B*3501 (PY) and -B*3503 (Px) Early After Seroconversion and After Development of AIDS |
| Brief 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. |
| Detailed 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Not Provided |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | 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. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Withdrawn |
| Enrollment ICMJE | 0 |
| Completion Date | September 2007 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE |
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. |
| Gender | Both |
| Ages | 21 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00340223 |
| Other Study ID Numbers ICMJE | 999905237, 05-C-N237 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Cancer Institute (NCI) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | May 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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