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

• Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women [ Time Frame: Enrollment (12-27 wks gestation) to 6 months postpartum ] [ Designated as safety issue: Yes ]
• Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation [ Time Frame: At 36 wks gestation ] [ Designated as safety issue: Yes ]

• • Immune status and Viral load at 6 months post partum in HIV-1 positive women
• • Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation

• Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: Yes ]
• Fetal death, premature delivery, and low birth weight [ Time Frame: Delivery ] [ Designated as safety issue: Yes ]

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.

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.

• HIV Infections
• Pregnancy Complications

• 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

• Active Comparator: Selenium
  Selenium (200 ug as selenomethionine)
  Intervention: Dietary Supplement: Selenium
• Placebo Comparator: Placebo
  Placebo
  Intervention: Dietary Supplement: Placebo

• Kupka R, Mugusi F, Aboud S, Hertzmark E, Spiegelman D, Fawzi WW. Effect of selenium supplements on hemoglobin concentration and morbidity among HIV-1-infected Tanzanian women. Clin Infect Dis. 2009 May 15;48(10):1475-8.
• Kupka R, Mugusi F, Aboud S, Msamanga GI, Finkelstein JL, Spiegelman D, Fawzi WW. Randomized, double-blind, placebo-controlled trial of selenium supplements among HIV-infected pregnant women in Tanzania: effects on maternal and child outcomes. Am J Clin Nutr. 2008 Jun;87(6):1802-8.

Inclusion Criteria:

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

Exclusion Criteria:

• Women with clinical AIDS defined according to WHO Criteria