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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115648
• Other study ID #: PEPI-Malawi
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2005
• Last updated: March 6, 2014
• Start date: April 2004
• Est. completion date: October 2009

Study information

• Verified date: March 2014
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3300
• Est. completion date: October 2009
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 54 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nevirapine
Oral NVP daily dosage
• AZT
Oral AZT daily
• NVP and AZT
Oral single dose NVP plus oral daily AZT during the first weeks
• NVP
Oral NVP daily to age 14 weeks
• NVP+AZT
Oral NVP daily plus oral AZT daly to age 14 weeks

Locations

Country	Name	City	State
Malawi	College of Medicine	Blantyre

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To determine overall infant survival rates at 6, 12, 18 and 24 months.		6,12,18 & 24 months	No