Skip to main content
OpenTrials
Completed

NCT Number: NCT00197561

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pregnancy Complications RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Muhimibili University College of Health Scienes

Upanga, Dar Es Salaaam, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 Infected women between 12 and 27 weeks of gestation

Exclusion criteria

  • Women with clinical AIDS defined according to WHO Criteria

Treatment and study plan

Placebo

Dietary Supplement

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

Selenium

Dietary Supplement

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

Primary outcomes

  1. 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

  2. Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation

    Time frame: At 36 wks gestation

Secondary outcomes

  1. Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum

    Time frame: 6 weeks postpartum

  2. Fetal death, premature delivery, and low birth weight

    Time frame: Delivery

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Nov 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.