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Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection

NCT00197561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 915

Last updated 2010-11-11

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections
  • Pregnancy Complications

Interventions

DIETARY_SUPPLEMENT

Placebo

Taken orally once per day from randomization through delivery and through the first 6 months after delivery.

DIETARY_SUPPLEMENT

Selenium

200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery

Sponsors & Collaborators

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Wafaie W. Fawzi, MD, DrPH · Harvard School of Public Health (HSPH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • Tanzania

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00197561 on ClinicalTrials.gov