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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2005-06-24
350
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 3 locations
1
Univ of California / San Francisco
San Francisco, California, United States, 94143
Status Unknown
2
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States, 20007
Status Unknown
3
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Status Unknown
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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