Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339430
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
HLA and KIR Associations With Infectious Viral Agents in an HIV Cohort of Women WIHS
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
HLA and KIR Associations With Infectious Viral Agents in an HIV Cohort of Women WIHS
Status:
COMPLETED
Status Verified Date:
2010-08-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Since the beginning of the HIVAIDS epidemic the number of women infected with HIV has rapidly increased and is continuing to climb The Womens Interagency HIV Study is being conducted in several cities in the United States to learn more about how HIV affects womens lives and bodies It will examine the role of HLA and killer immunoglobulin-like receptors KIR in HIV and related infections in HIV-positive and HIV-negative women The study will determine the relationship between KIR and HLA genes and the following the risk of HIV infection HIV levels in the blood incidence of AIDS response to highly active antiretroviral therapy HAART and response to immunotherapy
Approximately 3700 women will participate Participants will visit the clinic every 6 months for 4 years An HIV test will be given each time to HIV-negative women A questionnaire will also be administered A physical examination and gynecological examination will be given Blood vaginal swabs and urine will be collected for testing A biological impedance test will determine any changes in weight waist-to-hip ratios and breast and total body fat Low CD4 counts and hospitalizations for HIV are to be self-reported to study staff
Approximately 3700 women will participate Participants will visit the clinic every 6 months for 4 years An HIV test will be given each time to HIV-negative women A questionnaire will also be administered A physical examination and gynecological examination will be given Blood vaginal swabs and urine will be collected for testing A biological impedance test will determine any changes in weight waist-to-hip ratios and breast and total body fat Low CD4 counts and hospitalizations for HIV are to be self-reported to study staff
Detailed Description:
The aim of the study is to examine the role of HLA and killer immunolobulin-like receptors KIR in the natural history of HPV HCV and HBV in HIV-positive and HIV-negative women The immune response to viral infection mediated by T lymphocytes is HLA restricted suggesting that HLA class I and class II might be associated with risk of viral infection persistence and disease progression Natural killer NK cells are a unique group of lymphocytes involved in surveillance and killing of foreign or infected cells through a mechanism involving recognition of HLA molecules by an extremely diverse set of receptors on the NK cell surface A major group of these receptors are the KIRs Thus a relationship between KIR genotype and HIV infection is biologically plausible and requires further investigation in observational studies
The WIHS study is a prospective study which may allow us to answer questions relating to the role of host HLA and KIR genotype on duration of infection and the development of virus-associated diseases such as cervical cancer related to HPV infection and liver cancer HBV and HCV WIHS is a large racially and geographically diverse cohort of HIV positive n 2761 and risk-matched HIV-negative women n 942 The large size of the cohort will provide substantial statistical power which is of major importance in any HLA association study
The WIHS study is a prospective study which may allow us to answer questions relating to the role of host HLA and KIR genotype on duration of infection and the development of virus-associated diseases such as cervical cancer related to HPV infection and liver cancer HBV and HCV WIHS is a large racially and geographically diverse cohort of HIV positive n 2761 and risk-matched HIV-negative women n 942 The large size of the cohort will provide substantial statistical power which is of major importance in any HLA association study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-N253 | None | None | None |