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

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.

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.

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.