NCT00339430

Brief Summary

Since the beginning of the HIV/AIDS epidemic, the number of women infected with HIV has rapidly increased and is continuing to climb. The Women's Interagency HIV Study is being conducted in several cities in the United States to learn more about how HIV affects women's 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 3,700 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2010

Completed
Last Updated

July 2, 2017

Status Verified

August 18, 2010

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

HIV

Keywords

GenotypingHIVHPVHCVHBV

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • DNA and relevant clinical data from properly consented WIHS subjects (maximum estimated at 3500) will be provided to our lab for genotyping and analysis.

You may not qualify if:

  • No available subjects will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Parham P, Ohta T. Population biology of antigen presentation by MHC class I molecules. Science. 1996 Apr 5;272(5258):67-74. doi: 10.1126/science.272.5258.67.

    PMID: 8600539BACKGROUND

  • Hughes AL, Yeager M. Natural selection at major histocompatibility complex loci of vertebrates. Annu Rev Genet. 1998;32:415-35. doi: 10.1146/annurev.genet.32.1.415.

    PMID: 9928486BACKGROUND

  • Carrington M, Nelson GW, Martin MP, Kissner T, Vlahov D, Goedert JJ, Kaslow R, Buchbinder S, Hoots K, O'Brien SJ. HLA and HIV-1: heterozygote advantage and B*35-Cw*04 disadvantage. Science. 1999 Mar 12;283(5408):1748-52. doi: 10.1126/science.283.5408.1748.

    PMID: 10073943BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

July 15, 2002

Study Completion

August 18, 2010

Last Updated

July 2, 2017

Record last verified: 2010-08-18

Locations

US(1)