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
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
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...
Gender
FEMALE
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
Brooklyn, New York, United States
San Francisco, California, United States
Patients applied
Trial Officials
Reichelderfer P
Study Chair
Kovacs A
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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