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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections, Pregnancy Complications

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Selenium


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Selenium<br>Selenium (200 ug as selenomethionine) | Dietary Supplement: Selenium<br>* 200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Taken orally once per day from randomization through delivery and through the first 6 months after delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, HIV, Selenium, Nutrition, Women, Tanzania, Maternal and child health outcomes, HIV/AIDS, Pregnancy Outcome