Correlation of HIV-1 in Vaginocervical Secretions with Clinical, Virologic, Immunologic Parameters and Other Infections in Women
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Natural History
Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.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 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.350 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Natural History
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Univ of California / San Francisco
San Francisco, United StatesOpen Univ of California / San Francisco in Google MapsGeorgetown Univ Med Ctr
Washington D.C., United StatesSUNY / Health Sciences Ctr at Brooklyn
Brooklyn, United States