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



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

For Condition: Vitamin A Deficiency,HIV Seronegativity,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - HIV infected Exlusion Criteria: - Pregnant
Total Enrollment: 400

Location and Contact Information:

Overall Study Official:
JoanKreiss,  Principal Investigator,  Universiy of Washington, Seattle, WA


Additional Information:
Study ID Numbers:
  R01-AI343844; 
Study Start Date: 
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053612

Other Hiv Seronegativity Studies:
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2. Using the Drug Thalidomide to Stimulate T Cells in HIV Positive Patients

3. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

4. A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.

5. A Study of MKC-442 in Combination with Other Anti-HIV Drugs

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