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| Descriptive Information Fields | |||||||||
| Brief 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 | ||||||||
| 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 | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Natural History | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections | ||||||||
| Intervention † | |||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 350 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria Patients must have:
Required:
Exclusion Criteria Concurrent Medication: Excluded:
Prior Medication: Excluded:
Coital interaction during the 48 hours prior to study visit, as reported by subject and confirmed by a negative seminal fluid assay result. |
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| Gender | Female | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00000858 | ||||||||
| Organization ID | DATRI 009 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | November 1998 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | June 23, 2005 | ||||||||
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