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Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding

NCT00074412 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2026

Last updated 2023-02-16

Study results available
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Summary

The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.

Conditions

  • HIV Infections

Interventions

DRUG

Nevirapine

10 mg/ml oral suspension taken once daily up to 6 months of age. Dosage will increase throughout study.

DRUG

Nevirapine placebo

Oral suspension taken once daily up to 6 months of age

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

  • Hoosen M. Coovadia, MD, MBBS · Centre for HIV Networking (HIVAN), Nelson Mandela School of Medicine, University of Natal

  • Laura Guay, MD · Johns Hopkins University

  • Wafaie Fawzi, MD, PhD · Department of Nutrition, Harvard School of Public Health

  • Yvonne Maldonado, MD · Stanford University

  • Daya Moodley, MSc, PhD · Department of Obstetrics and Gynaecology, Nelson R Mandela School of Medicine, University of Natal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-09-30
Completion
2011-11-30

Countries

  • South Africa
  • Tanzania
  • Uganda
  • Zimbabwe

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 NCT00074412 on ClinicalTrials.gov