Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
Primary Purpose
HIV Infections, Vitamin A Deficiency, HIV Seronegativity
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vitamin A
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV-1, Women, Vitamin A, Shedding
Eligibility Criteria
Inclusion Criteria: HIV infected Exlusion Criteria: Pregnant
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00053612
First Posted
February 3, 2003
Last Updated
December 13, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00053612
Brief Title
Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
Official Title
Prevention of HIV Shedding in Women - Trial of Vitamin A
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
HIV infected individuals with vitamin A deficiency may be more likely to transmit the virus to others than HIV infected individuals who have normal levels of vitamin A. The presence of HIV DNA in vaginal secretions may indicate a greater risk for transmission of HIV to others. The purpose of this study is to determine if taking vitamin A decreases the level of HIV DNA in vaginal secretions.
Detailed Description
Vitamin A deficiency leads to pathological changes in mucosal epithelium, including the vagina, and is correlated with immune dysfunction in both HIV-1 infected and uninfected individuals. Recent studies of genital tract shedding of HIV-1 DNA in infected women have found that lower serum concentrations of vitamin A were strongly associated with detection of HIV-1 in vaginal secretions. In addition, maternal vitamin A deficiency has been associated with significantly increased risk of vertical HIV-1 transmission. This study will assess the effect of vitamin A supplementation on the prevalence and quantity of HIV-1 DNA and RNA in cervical and vaginal secretions.
Participants in this study will be HIV infected nonpregnant women in Mombasa, Kenya. Participants will be randomized to receive 6 weeks of daily dosage of either 10,000 IU vitamin A or placebo. Cervical and vaginal swabs will be obtained at enrollment and at Week 6 for detection and quantification of HIV-1 DNA and RNA. In addition, venous blood will be obtained at the two time points for quantification of plasma HIV-1 RNA, CD4 lymphocyte count, and serum vitamin A levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Vitamin A Deficiency, HIV Seronegativity
Keywords
HIV-1, Women, Vitamin A, Shedding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vitamin A
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV infected
Exlusion Criteria:
Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Kreiss, MD, MPH
Organizational Affiliation
Universiy of Washington, Seattle, WA
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
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