Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053612
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2003-02-03
Brief Title:
Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Prevention of HIV Shedding in Women - Trial of Vitamin A
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10000 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
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 10000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01-AI343844 | None | None | None |