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

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: Nevirapine; Drug: AZT; Drug: NVP; Drug: NVP and AZT; Drug: NVP+AZT

• Registration Number: NCT00115648
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-06-23
• Study First Submitted QC: 2005-06-23
• Study First Posted: 2005-06-24
• Primary Completion: 2007-08
• Study Completion: 2009-10
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Nevirapine	Single dose NVP + ZDV daily for the first week.
A	AZT	Single dose NVP + ZDV daily for the first week.
A	NVP and AZT	Single dose NVP + ZDV daily for the first week.
C	Nevirapine	Arm A plus NVP + ZDV daily to age 14 weeks.
C	NVP+AZT	Arm A plus NVP + ZDV daily to age 14 weeks.
B	Nevirapine	Arm A plus oral NVP daily to age 14 weeks.
B	NVP	Arm A plus oral NVP daily to age 14 weeks.
C	AZT	Arm A plus NVP + ZDV daily to age 14 weeks.

Primary Outcome Measures

Name	Time	Method
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.	9 months

Secondary Outcome Measures

Name	Time	Method
To determine overall infant survival rates at 6, 12, 18 and 24 months.	6,12,18 & 24 months

Trial Locations

Locations (1)

College of Medicine; 🇲🇼 Blantyre, Malawi