Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000858
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
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
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
1998-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 Womens Interagency HIV Study WIHS which is designed to elucidate the natural history of infection with HIV-1 in US women Participation in DATRI 009 will require additional blood at the patients 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
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 Womens Interagency HIV Study WIHS which is designed to elucidate the natural history of infection with HIV-1 in US women Participation in DATRI 009 will require additional blood at the patients 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: