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

Phase 3

Completed

• Conditions: HIV Infections; Pregnancy Complications
• Interventions: Dietary Supplement: Selenium; Dietary Supplement: Placebo

• Registration Number: NCT00197561
• Lead Sponsor: Harvard School of Public Health (HSPH)

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 Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 915

Inclusion Criteria

• HIV-1 Infected women between 12 and 27 weeks of gestation

Exclusion Criteria

• Women with clinical AIDS defined according to WHO Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selenium	Selenium	Selenium (200 ug as selenomethionine)
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women	Enrollment (12-27 wks gestation) to 6 months postpartum
Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation	At 36 wks gestation

Secondary Outcome Measures

Name	Time	Method
Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum	6 weeks postpartum
Fetal death, premature delivery, and low birth weight	Delivery

Trial Locations

Locations (1)

Muhimibili University College of Health Scienes; 🇹🇿 Upanga, Dar es Salaaam, Tanzania