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| 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 |
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 III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection |
| 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 |
|---|---|
|
Selenium: Active Comparator
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: Placebo Comparator
Placebo
|
Dietary Supplement: Placebo
Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Tanzania, Dar es Salaaam | |
| Muhimibili University College of Health Scienes | |
| Upanga, Dar es Salaaam, Tanzania | |
| Principal Investigator: | Wafaie W. Fawzi, MD, DrPH | Harvard School of Public Health |
More Information
| Responsible Party: | Harvard School of Public Health ( Wafaie Fawzi ) |
| Study ID Numbers: | HD43555 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00197561 History of Changes |
| Health Authority: | United States: Institutional Review Board; Tanzania: Institutional Review Board |
|
HIV Selenium Nutrition Women Pregnancy |
Tanzania Maternal and child health outcomes HIV/AIDS Pregnancy Outcome |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Antioxidants Slow Virus Diseases Pregnancy Complications Molecular Mechanisms of Pharmacological Action Immune System Diseases Growth Substances Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Trace Elements |
Infection Protective Agents Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Selenium HIV Infections Sexually Transmitted Diseases Lentivirus Infections Micronutrients Retroviridae Infections |