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Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV

NCT00074399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 775

Last updated 2009-08-07

No results posted yet for this study

Summary

HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.

Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.

Conditions

  • HIV Infections

Interventions

DRUG

Nevirapine

Tablet taken orally daily. Dosage depends on age and body surface area

DRUG

Nevirapine placebo

Placebo tablet taken orally daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • Ethiopia

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 NCT00074399 on ClinicalTrials.gov