NCT00115648

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,300 (estimated)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-08-01
• Completion: 2009-10-01
• First posted: 2005-06-24
• Last updated: 2014-03-07

Locations

1 site across 1 country: Malawi