Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
This study has been completed.
Sponsor:
Harvard School of Public Health
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Pregnancy Complications |
Dietary Supplement: Placebo Dietary Supplement: Selenium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Selenomethionine
U.S. FDA Resources
Further study details as provided by Harvard School of Public Health:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 915 |
| Study Start Date: | September 2003 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Selenium
Selenium (200 ug as selenomethionine)
|
Dietary Supplement: Selenium
200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery
|
|
Placebo Comparator: Placebo
Placebo
|
Dietary Supplement: Placebo
Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-1 Infected women between 12 and 27 weeks of gestation
Exclusion Criteria:
- Women with clinical AIDS defined according to WHO Criteria
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197561
Locations
| Tanzania | |
| Muhimibili University College of Health Scienes | |
| Upanga, Dar es Salaaam, Tanzania | |
Sponsors and Collaborators
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
| Principal Investigator: | Wafaie W. Fawzi, MD, DrPH | Harvard School of Public Health |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wafaie Fawzi, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00197561 History of Changes |
| Other Study ID Numbers: | HD43555 |
| Study First Received: | September 12, 2005 |
| Last Updated: | November 9, 2010 |
| Health Authority: | United States: Institutional Review Board Tanzania: Institutional Review Board |
Keywords provided by Harvard School of Public Health:
|
HIV Selenium Nutrition Women Pregnancy |
Tanzania Maternal and child health outcomes HIV/AIDS Pregnancy Outcome |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Pregnancy Complications Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Selenium Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013