Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT00197561
Status:
COMPLETED
Last Update Posted:
2010-11-11
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Sponsor:
Harvard School of Public Health (HSPH)
Organization:
Study Overview
Official Title:
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Status:
COMPLETED
Status Verified Date:
2010-11
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:
The purpose of this study is to determine whether the oral administration of daily selenium supplements to HIV-1 positive pregnant women: enhances immune status and reduces the HIV-1 viral load at six months postpartum, reduces the risk of lower genital shedding of HIV-1 infected cells at 36 weeks of gestation, and reduces the risk of mastitis at six weeks postpartum, compared to placebo.
Detailed Description:
We are recruiting pregnant women who are infected with HIV and assign them to receive selenium or placebo. All women will be given standard prenatal care, including nevirapine for the prevention of mother-to-child transmission and prenatal multivitamin supplements. We will examine the effect of the selenium supplements on intermediate outcomes predictive of the risks of transmission of HIV and to disease progression.
Study Oversight
Has Oversight DMC:
True
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?: