Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection - Full Text View

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:	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

MedlinePlus related topics: Breast Diseases HIV/AIDS HIV/AIDS and Pregnancy Postpartum Care

Drug Information available for: Selenomethionine Selenium

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:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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 February 13, 2012