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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00053612 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Vitamin A Deficiency HIV Seronegativity |
Drug: Vitamin A |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of HIV Shedding in Women - Trial of Vitamin A |
| Estimated Enrollment: | 400 |
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exlusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | R01AI343844, R01-AI343844 |
| Study First Received: | February 3, 2003 |
| Last Updated: | September 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00053612 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV-1 Women Vitamin A Shedding |
|
Anticarcinogenic Agents Sexually Transmitted Diseases, Viral Vision Disorders Antioxidants Keratomalacia Avitaminosis Malnutrition Retinol palmitate Vitamins Nutrition Disorders Micronutrients Retroviridae Infections Deficiency Diseases |
Vitamin A Deficiency Retinol Night Blindness Eye Diseases Acquired Immunodeficiency Syndrome Trace Elements Blindness Immunologic Deficiency Syndromes Virus Diseases HIV Infections Vitamin A Sexually Transmitted Diseases |
|
Anticarcinogenic Agents Sexually Transmitted Diseases, Viral Antioxidants Slow Virus Diseases Vision Disorders Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Avitaminosis Physiological Effects of Drugs Infection Malnutrition Retinol palmitate Therapeutic Uses Vitamins Nutrition Disorders |
Micronutrients Retroviridae Infections Deficiency Diseases Vitamin A Deficiency Night Blindness RNA Virus Infections Immune System Diseases Eye Diseases Growth Substances Acquired Immunodeficiency Syndrome Protective Agents Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV Infections |
