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Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies

NCT00120471 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-11-01

No results posted yet for this study

Summary

To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV drug approved for use in the United States for the treatment of HIV infected adults. The purpose of this study is to determine the safety, tolerability, and blood levels of TDF in HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi and Brazil.

Conditions

  • HIV Infections

Interventions

DRUG

Tenofovir disoproxil fumarate

600-mg tablet taken orally once daily

DRUG

Tenofovir disoproxil fumarate

4-mg/kg oral suspension taken at birth and on Days 3 and 5 after birth

DRUG

Tenofovir disoproxil fumarate

6-mg/kg oral suspension taken at birth and daily for 7 days after birth

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Mark Mirochnick, MD · Boston Medical Center

  • Taha Taha, MD, PhD · Johns Hopkins University

  • Regis Kreitchmann, MD · Centro Municipal de DST/AIDS, Irmandade Santa Casa de Misericordia de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • Brazil
  • Malawi

Study Locations

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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 NCT00120471 on ClinicalTrials.gov