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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197561
• Other study ID #: HD43555
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 9, 2010
• Start date: September 2003
• Est. completion date: August 2006

Study information

• Verified date: November 2010
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 915
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women with clinical AIDS defined according to WHO Criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection
• Pregnancy Complications

Intervention

Dietary Supplement:
• Placebo
Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
• Selenium
200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery

Locations

Country	Name	City	State
Tanzania	Muhimibili University College of Health Scienes	Upanga	Dar es Salaaam

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation		At 36 wks gestation	Yes
Secondary	Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum		6 weeks postpartum	Yes
Secondary	Fetal death, premature delivery, and low birth weight		Delivery	Yes