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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Infection
Communicable Diseases
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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on October 01, 2014