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

Phase 3CompletedNCT00197561

Harvard School of Public Health (HSPH)915 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

915

Conditions

HIV Infections Pregnancy Complications

Interventions

PlaceboDIETARY_SUPPLEMENT

Taken orally once per day from randomization through delivery and through the first 6 months after delivery.

SeleniumDIETARY_SUPPLEMENT

200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV-1 Infected women between 12 and 27 weeks of gestation Exclusion Criteria: * Women with clinical AIDS defined according to WHO Criteria

Locations (1)

Muhimibili University College of Health Scienes

Upanga, Dar Es Salaaam, Tanzania

Outcomes

Primary Outcomes

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

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

Time frame: At 36 wks gestation

Secondary Outcomes

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

Time frame: 6 weeks postpartum

Fetal death, premature delivery, and low birth weight

Time frame: Delivery

Data from ClinicalTrials.gov

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