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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00053612
Enrollment
400
Registered
2003-02-05
Start date
Unknown
Completion date
2006-06-30
Last updated
2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, HIV Seronegativity, Vitamin A Deficiency

Keywords

HIV-1, Women, Vitamin A, Shedding

Brief 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.

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.

Interventions

DRUGVitamin A

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* HIV infected Exlusion Criteria: * Pregnant

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026