Detection of Human Immunodeficiency Virus Type 1 (HIV-1) in Vaginocervical Secretions: Correlation With Clinical Status, Virologic and Immunologic Parameters, and the Presence of Other Infections

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000858

Collaborator

(none)

350

Enrollment

Locations

116.7

Patients Per Site

Study Details

Study Description

Brief Summary

To correlate HIV-1 viral load in vaginocervical secretions (VCS), as measured by culture and nucleic acid detection, with that found in peripheral blood and HIV clinical status. To determine whether systemic and local HIV specific antibody influences the quality and type of virus isolated from VCS. To ascertain whether the presence of specific infectious agents (e.g., HPV, HSV, CMV, etc.) influences the amount and type of virus isolated from VCS.

Predictors for the development of the acquired immunodeficiency syndrome (AIDS) in HIV infected individuals have been studied primarily among adult males and in selected small populations. Although many of these predictors may be relevant to women, HIV infection does manifest itself differently between the sexes. Therefore, it is important to study the spectrum of HIV disease in women and to identify unique and common markers, cofactors, and predictors of disease progression.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections

Detailed Description

Part 009: HIV-infected female adults, independent of CD4+ cell count, will provide blood and VCS specimens obtained at a single study visit, regardless of ovulatory phase.

NOTE: Subjects in this study will be patients who are currently enrolled in a multisite longitudinal study, Women's Interagency HIV Study (WIHS), which is designed to elucidate the natural history of infection with HIV-1 in U.S. women. Participation in DATRI 009 will require additional blood at the patient's scheduled WIHS visit.

Part 009a: Consent will be obtained from 65 women to allow additional evaluations to be completed on their reserve VCS specimen and on an additional peripheral blood specimen, specifically obtained for DATRI 009a during their 009 visit. An additional 8 ml CPT tube will be collected from these patients, bringing their total blood volume to 32 ml at their scheduled WIHS visit.

Study Design

Study Type:

Observational

Observational Model:

Natural History

Official Title:

Detection of Human Immunodeficiency Virus Type 1 (HIV-1) in Vaginocervical Secretions: Correlation With Clinical Status, Virologic and Immunologic Parameters, and the Presence of Other Infections

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have:

Premenopausal status.
Intact uterus and cervix.
Documented HIV infection.
Current enrollment in a multisite longitudinal study, Women's Interagency HIV Study (WIHS).

Required:

Stable or no antiretroviral therapy within 1 month prior to study entry.

Exclusion Criteria

Concurrent Medication:

Excluded:

Antifungal or antimicrobial medication in the vagina.

Prior Medication:

Excluded:

Antimicrobial or antifungal medications during the 48 hours prior to study entry.
Use of spermicide or douche in the 48 hours prior to entry.

Coital interaction during the 48 hours prior to study visit, as reported by subject and confirmed by a negative seminal fluid assay result.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of California / San Francisco	San Francisco	California	United States	94143
2	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
3	SUNY / Health Sciences Ctr at Brooklyn	Brooklyn	New York	United States	11203