NCT00197561

Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 915 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Pregnancy Complications

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
DIETARY_SUPPLEMENT	Selenium	200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery

Timeline

• Start date: 2003-09-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2005-09-20
• Last updated: 2010-11-11

Locations

1 site across 1 country: Tanzania