HIV Infections, Pregnancy Complications
Conditions
Keywords
HIV, Selenium, Nutrition, Women, Pregnancy, Tanzania, Maternal and child health outcomes, HIV/AIDS, Pregnancy Outcome
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
DIETARY_SUPPLEMENTSelenium
200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery
Sponsors
Muhimbili University of Health and Allied Sciences
Harvard School of Public Health (HSPH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 Infected women between 12 and 27 weeks of gestation
Exclusion criteria
* Women with clinical AIDS defined according to WHO Criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women | Enrollment (12-27 wks gestation) to 6 months postpartum |
| Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation | At 36 wks gestation |
Secondary
| Measure | Time frame |
|---|---|
| Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum | 6 weeks postpartum |
| Fetal death, premature delivery, and low birth weight | Delivery |
Countries
Tanzania
Outcome results
None listed