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

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Nevirapine; Drug: AZT; Drug: NVP; Drug: NVP and AZT; Drug: NVP+AZT

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00115648

PEPI-Malawi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,300 estimated patients

Sex: All

Ages: 18 to 54 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,300 participants in 3 patient groups

A

Active Comparator group

Description:

Single dose NVP + ZDV daily for the first week.

Treatment:

Drug: NVP and AZT

Drug: Nevirapine

Drug: AZT

C

Experimental group

Description:

Arm A plus NVP + ZDV daily to age 14 weeks.

Treatment:

Drug: NVP+AZT

Drug: Nevirapine

Drug: AZT

B

Experimental group

Description:

Arm A plus oral NVP daily to age 14 weeks.

Treatment:

Drug: NVP

Drug: Nevirapine