HIV Infections Clinical Trial
Official title:
Prevention of HIV Shedding in Women - Trial of Vitamin A
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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