Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
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|ClinicalTrials.gov Identifier: NCT00053612|
Recruitment Status : Completed
First Posted : February 5, 2003
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Vitamin A Deficiency HIV Seronegativity||Drug: Vitamin A||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of HIV Shedding in Women - Trial of Vitamin A|
|Primary Completion Date :||June 2006|
|Study Completion Date :||June 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053612
|Principal Investigator:||Joan Kreiss, MD, MPH||Universiy of Washington, Seattle, WA|