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

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: Pregnancy Complications; HIV Infections

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Selenium

Study type: Interventional

Funder types: Other

Identifiers

NCT00197561

HD43555

Details and patient eligibility

About

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.

Full 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.

Enrollment: 915 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Women with clinical AIDS defined according to WHO Criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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915 participants in 2 patient groups, including a placebo group

Selenium

Active Comparator group

Description:

Selenium (200 ug as selenomethionine)

Treatment:

Dietary Supplement: Selenium

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo