Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

FEMALE

18-45 years

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 s...

Detailed Description

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 ma...

Eligibility Criteria

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.

Key Trial Info

Start Date :

Trial Type :

OBSERVATIONAL

End Date :

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT00000858

Last Update

June 24 2005

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Univ of California / San Francisco

San Francisco, California, United States, 94143

2

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States, 20007

3

SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, New York, United States, 11203