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

Johns Hopkins Bloomberg School of Public Health3,300 enrolled

Overview

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.

This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT given twice daily for 1 week (comparison regimen). All infants receive the comparison regimen at birth and then randomized at birth to start either one of the two extended regimens after the first week. The extended regimens are nevirapine daily and nevirapine plus AZT daily - both regimens are given up to age 14 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

3,300

Conditions

HIV Infections

Interventions

NevirapineDRUG

Oral NVP daily dosage

AZTDRUG

Oral AZT daily

NVP and AZTDRUG

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

NVP

Eligibility

Sex: ALLMin age: 18 YearsMax age: 54 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Had given birth within the last 24 hours * Ability and willingness to give informed consent for HIV testing and enrollment into the study * Willing to receive HIV results * HIV infected * Planning to deliver or had given birth at the study clinics * Willing to come back for follow-up visits for 2 years postnatally * Resident of Blantyre city or its suburbs Exclusion Criteria: * HIV negative * Women with discordant HIV results * Women who indicate that they will not breastfeed at time of delivery * Inability or unwillingness to follow any of the inclusion requirements * Newborn with life-threatening condition * Women who previously enrolled in this study and have a second pregnancy cannot reenroll

Locations (1)

College of Medicine

Blantyre, Malawi

Outcomes

Primary Outcomes

A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.

Time frame: 9 months

Secondary Outcomes

To determine overall infant survival rates at 6, 12, 18 and 24 months.

Time frame: 6,12,18 & 24 months

Data from ClinicalTrials.gov

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