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

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What is being collected

Data Collection

Who is being recruted

HIV Infections

From 18 to 45 Years
How is the trial designed

Natural History

Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.
Observational

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleDetection 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 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
350 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Natural History
These studies observe how a disease progresses over time without active treatment. They help researchers understand how conditions typically develop, change, and impact quality of life.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 45 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



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
Suspended
Univ of California / San FranciscoSan Francisco, United StatesSee the location
Suspended
Georgetown Univ Med CtrWashington, United States
Suspended
SUNY / Health Sciences Ctr at BrooklynBrooklyn, United States

Completed3 Study Centers