Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Vitamin A Deficiency; HIV Seronegativity
Intervention: Vitamin A (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Joan Kreiss, MD, MPH, Principal Investigator, Affiliation: Universiy of Washington, Seattle, WA
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.
Clinical Details
Official title: Prevention of HIV Shedding in Women - Trial of Vitamin A
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- HIV infected
Exlusion Criteria:
- Pregnant
Locations and Contacts
Additional Information
Last updated: September 17, 2007
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