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

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197561
First received: September 12, 2005
Last updated: November 9, 2010
Last verified: November 2010

September 12, 2005
November 9, 2010
September 2003
August 2006   (final data collection date for primary outcome measure)
  • Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women [ Time Frame: Enrollment (12-27 wks gestation) to 6 months postpartum ] [ Designated as safety issue: Yes ]
  • Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation [ Time Frame: At 36 wks gestation ] [ Designated as safety issue: Yes ]
  • • Immune status and Viral load at 6 months post partum in HIV-1 positive women
  • • Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation
Complete list of historical versions of study NCT00197561 on ClinicalTrials.gov Archive Site
  • Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: Yes ]
  • Fetal death, premature delivery, and low birth weight [ Time Frame: Delivery ] [ Designated as safety issue: Yes ]
Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 wks post partum
Not Provided
Not Provided
 
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Pregnancy Complications
  • Dietary Supplement: Placebo
    Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
  • Dietary Supplement: Selenium
    200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery
  • Active Comparator: Selenium
    Selenium (200 ug as selenomethionine)
    Intervention: Dietary Supplement: Selenium
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
915
August 2006
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Women with clinical AIDS defined according to WHO Criteria
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00197561
HD43555
Yes
Wafaie Fawzi, Harvard School of Public Health
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Principal Investigator: Wafaie W. Fawzi, MD, DrPH Harvard School of Public Health
Harvard School of Public Health
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP