| September 12, 2005 |
| September 8, 2009 |
| 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 |
| |
| 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. |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- HIV Infections
- Pregnancy Complications
|
- Dietary Supplement: Placebo
- Dietary Supplement: Selenium
|
- Active Comparator: Selenium (200 ug as selenomethionine)
- Placebo Comparator: Placebo
|
- 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.
- Kupka R, Mugusi F, Aboud S, Msamanga GI, Finkelstein JL, Spiegelman D, Fawzi WW. Randomized, double-blind, placebo-controlled trial of selenium supplements among HIV-infected pregnant women in Tanzania: effects on maternal and child outcomes. Am J Clin Nutr. 2008 Jun;87(6):1802-8.
|
| |
| 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 |
| Wafaie Fawzi, Harvard School of Public Health |
| HD43555 |
| 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 |
| September 2009 |