Nevirapine Study for the Prevention of Maternal-Infant HIV Transmission in Uganda

April 1, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase III Randomized Clinical Trial of the Standard Two Dose Nevirapine (NVP) Regimen With the Addition of HIV Immune Globulin(HIVIGLOB) or Extended Infant NVP Dosing Compared With the Standard NVP Regimen Alone for the Prevention of Maternal-Infant HIV Transmission in Uganda

The increase in pediatric HIV infection has a substantial impact on childhood mortality in the developing world. A number of recent studies suggest that as many as half or more of mother-to-child HIV transmissions in developing countries occur in late pregnancy or during labor and delivery. Interventions targeted during the perinatal period have shown to be effective and to have a significant impact in reducing transmission. The purpose of this study is to investigate the effectiveness of nevirapine (NVP) plus immunoprophylaxis or extended NVP dosing regimens in HIV-infected pregnant women and their infants during the perinatal period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is an urgent need to find safe, effective means of preventing mother-to-child-transmission (MTCT) of HIV that can be used in developing countries. One of the greatest obstacles to prevention in these areas remains HIV transmission through breast milk. The primary purpose of this trial is to determine if nevirapine (NVP) plus immunoprophylaxis (by intravenous HIV immune globulin [HIVIGLOB]) or extended NVP dosing of the neonate during the perinatal period can safely and effectively reduce the risk of peripartum or early breastfeeding-related HIV MTCT.

This study will last 11-18 weeks for each mother and 18 months for each infant. HIV-infected pregnant women will be randomly assigned to one of three arms. Participants in Arm 1 will receive a single dose of 200 mg NVP orally at the onset of labor. Infants in Arm 1 will receive a single dose of 2 mg/kg NVP orally within the first week after delivery. Arm 2 participants will receive a single dose of 200 mg NVP orally at the onset of labor. Infants in Arm 2 will receive 2 mg/kg NVP orally within the first week after delivery and 5 mg NVP taken orally daily from Day 8 through Week 6. Arm 3 participants will receive a 12 gm intravenous dose of HIVIGLOB at 36-37 weeks gestation and 200 mg NVP orally at the onset of labor. Infants in Arm 3 will receive a single 1.2 gm intravenous dose HIVIGLOB within 18 hours of birth and 2 mg/kg NVP orally within the first week after delivery.

There will be five or six study visits for pregnant participants. A targeted medical history, physical examination, and blood collection will occur at all visits. After birth, there will be 11 study visits for infants in Arms 1 and 2 and 12 study visits for infants in Arm 3. Medical history and a targeted physical exam will occur at all visits. Blood collection will occur at some visits.

Study Type

Interventional

Enrollment (Actual)

722

Phase

  • Phase 3

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:

  • Pregnant between 32-36 weeks estimated gestation
  • HIV Infected
  • Intent to breastfeed infant
  • Certain laboratory criteria. More information on this criterion can be found in the protocol.

Exclusion Criteria:

  • Sensitivity to immune globulin preparations or any benzodiazepine
  • Clinically significant disease, as determined by the investigator, that would compromise the ability of the participant to complete the study requirements
  • Currently receiving antiretroviral therapy (other than the intrapartum NVP or other peripartum regimens)
  • Participation in any HIV vaccine trials
  • History of cytotoxic chemotherapy within one month of study entry
  • Uncontrolled hypertension
  • Chronic alcohol or illicit drug use
  • History of non-compliance with visits or medication
  • Women who become pregnant again during study follow-up will not be eligible for re-enrollment in the trial

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1

Mother dosing regimen: Single dose of 200 mg NVP taken orally at onset of labor

Infant dosing regimen: Single dose of 2 mg/kg NVP taken orally within the first week after delivery
Drug: Nevirapine
200 mg Nevirapine tablet
Other Names:
  • NVP Viramune
Experimental: 2

Mother dosing regimen: Single dose of 200 mg NVP taken orally at onset of labor

Infant dosing regimen: 2 mg/kg NVP taken orally within the first week after delivery and 5 mg NVP taken orally daily from Day 8 through Week 6
Drug: Nevirapine
200 mg Nevirapine tablet
Other Names:
  • NVP Viramune
Experimental: 3

Mother dosing regimen: Single 12 gm intravenous dose of HIVIGLOB at 36 - 37 weeks gestation and 200 mg NVP taken orally at onset of labor

Infant dosing regimen: Single 1.2 gm intravenous dose HIVIGLOB within 18 hours of birth and 2 mg/kg NVP taken orally within the first week after delivery
Drug: Nevirapine
200 mg Nevirapine tablet
Other Names:
  • NVP Viramune
Drug: HIV immune globulin solution
5% intravenous HIV immune globulin solution
Other Names:
  • HIVIGLOB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of HIV infection in infants born to study participants in each arm of the study
Time Frame: At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18
At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18
Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of immunologic progression in HIV-infected infants in each arm
Time Frame: Throughout study
Throughout study
Infant mortality
Time Frame: Throughout study
Throughout study
Maternal plasma HIV RNA levels at delivery
Time Frame: At Birth
At Birth
Immunologic, virologic, and pharmacologic factors
Time Frame: Throughout study
Throughout study

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: Brooks Jackson, MD, Johns Hopkins School of Medicine

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

July 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

April 2, 2008

Last Update Submitted That Met QC Criteria

April 1, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AI034235 (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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