Daily Nevirapine to Prevent Mother to Infant Transmission of HIV (SWEN)

July 30, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Prevention of Maternal to Infant HIV Transmission in India

Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the safety and effectiveness of adding daily infant NVP to standard prevention measures to decrease vertical transmission of HIV.

According to current statistics from the study site, approximately 70% of the pregnant HIV infected women in this study will have begun antenatal ZDV prior to the initiation of NVP at labor. The remaining 30% of the HIV infected women enrolled in this trial will have been previously undiagnosed. These women will be diagnosed with HIV infection either at the time they present to the delivery room in stage 1 of labor or immediately postpartum if they present for delivery late in labor and cannot provide informed consent for HIV screening prior to delivery.

All infants will receive the standard does of NVP at 72 hours postpartum. Infants will then be randomized to receive either daily NVP and a daily multivitamin (MVI) or a daily MVI alone. Infants will take NVP/MVI or MVI alone during Weeks 2 to 6 postpartum. The primary outcome measure is infant HIV infection rates at 6 months.

Two additional related cohorts of women will be followed for comparison: 1) an equal number of HIV uninfected women and their children will be enrolled for comparison of postpartum morbidity and mortality; and 2) consenting HIV infected women and their children who choose not to enroll in the clinical trial or are ineligible because they are not breastfeeding will be enrolled in an ancillary cohort.

Study Type

Interventional

Enrollment (Actual)

770

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

  • India
      • Pune, India
        • BJ Medical College

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria for Pregnant or Postpartum Mothers

  • HIV infected
  • Planning to breastfeed
  • Able to tolerate oral drugs and available for 12 months of postpartum follow-up

Exclusion Criteria

  • Significant physical or emotional distress
  • Infant with serious or life threatening disease or severe fetal abnormality
  • Obstetrical complications affecting maternal health
  • Prior antiretroviral drugs (except antenatal ZDV or intrapartum (NVP)

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum
Drug: Nevirapine and mulitvitamins
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
Other Names:
  • Viramune® (Boehringer Ingelheim)
Experimental: 2
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day)by mouth, from week 1 through week 6 post-partum Infants: Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
Drug: Nevirapine and mulitvitamins
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
Other Names:
  • Viramune® (Boehringer Ingelheim)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV infection rate of infants
Time Frame: 6 months of age
6 months of age
Safety of the regimens for HIV-infected mothers and their breast-fed infants
Time Frame: Through 12 months post-partum
Through 12 months post-partum

Secondary Outcome Measures

Outcome Measure
Time Frame
Acceptability and compliance of intervention regimens
Time Frame: Until 6 weeks of age
Until 6 weeks of age
Time to HIV infection by treatment regimen
Time Frame: over 12 months of age
over 12 months of age
Time to infection by infant feeding practice and time to weaning
Time Frame: Until 12 months post-partum
Until 12 months post-partum
Maternal ZDV and NVP resistance
Time Frame: Baseline and post-partum
Baseline and post-partum
Infant morbidity and mortality by treatment arm
Time Frame: Until 12 months post partum
Until 12 months post partum
Infant NVP resistance by treatment arm
Time Frame: Up to 12 months post partum
Up to 12 months post partum
Maternal NVP pharmacokinetics
Time Frame: Up to 12 months post-partum
Up to 12 months post-partum
Infant NVP pharmacokinetics
Time Frame: Up to 12 months post-partum
Up to 12 months post-partum

Collaborators and Investigators

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Robert C. Bollinger, MD, MPH, Johns Hopkins University

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

August 1, 2002

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 23, 2003

First Submitted That Met QC Criteria

May 27, 2003

First Posted (Estimate)

May 28, 2003

Study Record Updates

Last Update Posted (Estimate)

July 31, 2008

Last Update Submitted That Met QC Criteria

July 30, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01AI045462-04 (U.S. NIH Grant/Contract)

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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