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A Study of Zidovudine/Lamivudine and Either Nevirapine or Nelfinavir for Reduction of Mother-to-child HIV Transmission During Breastfeeding

NCT00146380 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2025-04-15

No results posted yet for this study

Summary

The purpose of the study is to demonstrate that a regimen using highly active antiretroviral therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and during the first six months of lactation is safe, effective and can be implemented in resource poor settings in order to reduce the risk of HIV transmission to the infant.

Conditions

  • HIV Infections

Interventions

DRUG

Zidovudine/Lamivudine and either Nevirapine or Nelfinavir

Zidovudine 300mg po bid from 34 weeks gestation to 6 months postpartum Lamivudine 150mg po bid from 34 weeks gestation to 6 months postpartum AND EITHER Nevirapine 200mg po qd for 2 weeks as lead in then bid from 34 weeks gestation to 6 months postpartum OR Nelfinavir 1250mg po bid from 34 weeks gestation to 6 months postpartum ARVs continued for those that meet WHO treatment criteria

BEHAVIORAL

Breastfeeding for 6 months postpartum

Exclusive breastfeeding till five and one half months with rapid weaning over 2 weeks and cessation of breastfeeding at 6 months when ARVs are discontinued

Sponsors & Collaborators

Principal Investigators

  • Timothy K Thomas, MD · Centers for Disease Control and Prevention

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2009-01-31
Completion
2013-01-31

Countries

  • Kenya

Study Locations

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Entities

Companies

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 NCT00146380 on ClinicalTrials.gov