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Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

NCT00115648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3300

Last updated 2014-03-07

No results posted yet for this study

Summary

The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.

Conditions

  • HIV Infections

Interventions

DRUG

Nevirapine

Oral NVP daily dosage

DRUG

AZT

Oral AZT daily

DRUG

NVP and AZT

Oral single dose NVP plus oral daily AZT during the first weeks

DRUG

NVP

Oral NVP daily to age 14 weeks

DRUG

NVP+AZT

Oral NVP daily plus oral AZT daly to age 14 weeks

Sponsors & Collaborators

  • Centers for Disease Control and Prevention

    collaborator FED

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

    collaborator NIH

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Taha E Taha, MD PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-08-31
Completion
2009-10-31

Countries

  • Malawi

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 NCT00115648 on ClinicalTrials.gov