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Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00053612
First received: February 3, 2003
Last updated: September 17, 2007
Last verified: August 2007

February 3, 2003
September 17, 2007
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Complete list of historical versions of study NCT00053612 on ClinicalTrials.gov Archive Site
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Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • Vitamin A Deficiency
  • HIV Seronegativity
Drug: Vitamin A
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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Inclusion Criteria:

  • HIV infected

Exlusion Criteria:

  • Pregnant
Female
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Contact information is only displayed when the study is recruiting subjects
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NCT00053612
R01AI343844, R01-AI343844
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Joan Kreiss, MD, MPH Universiy of Washington, Seattle, WA
National Institute of Allergy and Infectious Diseases (NIAID)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP