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

Condition(s) targeted: HIV Infections; Pregnancy Complications

Intervention: Placebo (Dietary Supplement); Selenium (Dietary Supplement)

Phase: Phase 3

Status: Completed

Sponsored by: Harvard School of Public Health

Official(s) and/or principal investigator(s):
Wafaie W. Fawzi, MD, DrPH, Principal Investigator, Affiliation: Harvard School of Public Health

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.

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

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women

Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation

Secondary outcome:

Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum

Fetal death, premature delivery, and low birth weight

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Women with clinical AIDS defined according to WHO Criteria

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

Starting date: September 2003
Ending date: August 2006
Last updated: May 19, 2008