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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000858
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Natural History
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 350
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000858

Locations
United States, California
Univ of California / San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, New York
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Sponsors and Collaborators
Investigators
Study Chair: Reichelderfer P
Study Chair: Kovacs A
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000858     History of Changes
Other Study ID Numbers: DATRI 009
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-1
Vagina

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014