Clinical trial NCT00197561: Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Official title: Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Pregnancy Complications
Keywords: HIV
Selenium
Nutrition
Women
Pregnancy
Tanzania
Maternal and child health outcomes
HIV/AIDS
Pregnancy Outcome
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2005-09-20
Enrollment: 915
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women
timeFrame: Enrollment (12-27 wks gestation) to 6 months postpartum
measure: Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation
timeFrame: At 36 wks gestation
Secondary outcomes:
measure: Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum
timeFrame: 6 weeks postpartum
measure: Fetal death, premature delivery, and low birth weight
timeFrame: Delivery
Other outcomes:
Locations:
city: Upanga
country: Tanzania
facility: Muhimibili University College of Health Scienes
state: Dar es Salaaam
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W. Fawzi, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1086/598334.
citation: 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. doi: 10.1093/ajcn/87.6.1802.