Daily Nevirapine to Prevent Mother to Infant Transmission of HIV (SWEN)
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ClinicalTrials.gov Identifier: NCT00061321 |
Recruitment Status
:
Completed
First Posted
: May 28, 2003
Last Update Posted
: July 31, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Nevirapine and mulitvitamins | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 770 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prevention of Maternal to Infant HIV Transmission in India |
Study Start Date : | August 2002 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | September 2007 |

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
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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)
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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)
|
- HIV infection rate of infants [ Time Frame: 6 months of age ]
- Safety of the regimens for HIV-infected mothers and their breast-fed infants [ Time Frame: Through 12 months post-partum ]
- Acceptability and compliance of intervention regimens [ Time Frame: Until 6 weeks of age ]
- Time to HIV infection by treatment regimen [ Time Frame: over 12 months of age ]
- Time to infection by infant feeding practice and time to weaning [ Time Frame: Until 12 months post-partum ]
- Maternal ZDV and NVP resistance [ Time Frame: Baseline and post-partum ]
- Infant morbidity and mortality by treatment arm [ Time Frame: Until 12 months post partum ]
- Infant NVP resistance by treatment arm [ Time Frame: Up to 12 months post partum ]
- Maternal NVP pharmacokinetics [ Time Frame: Up to 12 months post-partum ]
- Infant NVP pharmacokinetics [ Time Frame: Up to 12 months post-partum ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061321
India | |
BJ Medical College | |
Pune, India |
Principal Investigator: | Robert C. Bollinger, MD, MPH | Johns Hopkins University |
Publications of Results:
Other Publications:
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 ( U.S. NIH Grant/Contract ) |
First Posted: | May 28, 2003 Key Record Dates |
Last Update Posted: | July 31, 2008 |
Last Verified: | August 2007 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Nevirapine |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |