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

March 6, 2014 updated by: Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi, 1331
        • College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Single dose NVP + ZDV daily for the first week.
Drug: Nevirapine
Oral NVP daily dosage
Drug: AZT
Oral AZT daily
Other Names:
  • Zidovuidne (ZDV)
Drug: NVP and AZT
Oral single dose NVP plus oral daily AZT during the first weeks
Other Names:
  • Nevirapine and zidovudine
Experimental: C
Arm A plus NVP + ZDV daily to age 14 weeks.
Drug: Nevirapine
Oral NVP daily dosage
Drug: AZT
Oral AZT daily
Other Names:
  • Zidovuidne (ZDV)
Drug: NVP+AZT
Oral NVP daily plus oral AZT daly to age 14 weeks
Other Names:
  • Nevirapine plus zidovudine
Experimental: B
Arm A plus oral NVP daily to age 14 weeks.
Drug: Nevirapine
Oral NVP daily dosage
Drug: NVP
Oral NVP daily to age 14 weeks
Other Names:
  • Nevirapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine overall infant survival rates at 6, 12, 18 and 24 months.
Time Frame: 6,12,18 & 24 months
6,12,18 & 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Taha E Taha, MD PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 23, 2005

First Submitted That Met QC Criteria

June 23, 2005

First Posted (Estimate)

June 24, 2005

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEPI-Malawi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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