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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 Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including 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. 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 Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Participants oftentimes recieve the finest healthcare available for their 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 condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > 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 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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Female
Protocol Entry 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.
Total Enrollment: 350
Location and Contact Information:
Overall Study Official:
ReichelderferP, Study Chair,
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of California / San Francisco
San Francisco, California, 94143
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
United States
Additional Information:
Study ID Numbers: DATRI 009;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000858
Other Hiv Infections Studies:
1. A Double-Blind, Randomized Parallel Group Study Comparing Procysteine to Placebo in HIV-Infected Patients Who Are Taking Antiretroviral Nucleosides
2. Viracept Expanded Access Program
3. Pharmacokinetics of Intermittent Isoniazid
4. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
5. A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients with PGL and/or Constitutional Disease
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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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