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Daily Nevirapine to Prevent Mother to Infant Transmission of HIV

NCT00061321 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2008-07-31

No results posted yet for this study

Summary

Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.

Conditions

  • HIV Infections

Interventions

DRUG

Nevirapine and mulitvitamins

Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Robert C. Bollinger, MD, MPH · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2007-04-30
Completion
2007-09-30

Countries

  • India

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 NCT00061321 on ClinicalTrials.gov