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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00197561
Other study ID # HD43555
Secondary ID
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


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
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