Trial record 1 of 1 for:    NCT00061321
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Daily Nevirapine to Prevent Mother to Infant Transmission of HIV (SWEN)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00061321
First received: May 23, 2003
Last updated: July 30, 2008
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nevirapine and mulitvitamins
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Maternal to Infant HIV Transmission in India

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • HIV infection rate of infants [ Time Frame: 6 months of age ] [ Designated as safety issue: No ]
  • Safety of the regimens for HIV-infected mothers and their breast-fed infants [ Time Frame: Through 12 months post-partum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acceptability and compliance of intervention regimens [ Time Frame: Until 6 weeks of age ] [ Designated as safety issue: No ]
  • Time to HIV infection by treatment regimen [ Time Frame: over 12 months of age ] [ Designated as safety issue: No ]
  • Time to infection by infant feeding practice and time to weaning [ Time Frame: Until 12 months post-partum ] [ Designated as safety issue: No ]
  • Maternal ZDV and NVP resistance [ Time Frame: Baseline and post-partum ] [ Designated as safety issue: No ]
  • Infant morbidity and mortality by treatment arm [ Time Frame: Until 12 months post partum ] [ Designated as safety issue: Yes ]
  • Infant NVP resistance by treatment arm [ Time Frame: Up to 12 months post partum ] [ Designated as safety issue: Yes ]
  • Maternal NVP pharmacokinetics [ Time Frame: Up to 12 months post-partum ] [ Designated as safety issue: No ]
  • Infant NVP pharmacokinetics [ Time Frame: Up to 12 months post-partum ] [ Designated as safety issue: No ]

Enrollment: 770
Study Start Date: August 2002
Study Completion Date: September 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Viramune® (Boehringer Ingelheim)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061321

Locations
India
BJ Medical College
Pune, India
Sponsors and Collaborators
Investigators
Principal Investigator: Robert C. Bollinger, MD, MPH Johns Hopkins University
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert C. Bollinger MD, MPH, Johns Hopkins School of Medicine
ClinicalTrials.gov Identifier: NCT00061321     History of Changes
Other Study ID Numbers: 5R01AI045462-04
Study First Received: May 23, 2003
Last Updated: July 30, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Nevirapine
Pregnancy
Maternal to Infant transmission
Infant
Breastfeeding
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014