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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

May 23, 2003
July 30, 2008
August 2002
April 2007   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00061321 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Daily Nevirapine to Prevent Mother to Infant Transmission of HIV
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
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)
  • 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
    Intervention: Drug: Nevirapine and mulitvitamins
  • 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
    Intervention: Drug: Nevirapine and mulitvitamins

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
770
September 2007
April 2007   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00061321
5R01AI045462-04
Yes
Robert C. Bollinger MD, MPH, Johns Hopkins School of Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Robert C. Bollinger, MD, MPH Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP