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Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers

NCT01511237 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2021-10-22

No results posted yet for this study

Summary

The purpose is to evaluate the efficacy of maternal and infant perinatal antiretroviral prophylaxis intensification for the prevention of mother-to-child intrapartum transmission of HIV-1 in women receiving less than 8 weeks of antiretroviral prophylaxis during pregnancy.

Conditions

  • HIV Infections

Interventions

DRUG

Nevirapine, zidovudine, lamivudine

* Mothers: One NVP 200 mg tablet at onset of labor with continuation of HAART for four weeks postpartum * Newborn: AZT+3TC+ NVP for 2 weeks, followed by AZT+3TC for 2 weeks: * NVP syrup 2 mg/kg every 24 hours for seven days, followed by NVP syrup 4 mg/kg every 24 hours for seven days. Newborns less than 2500 g will be administered 2mg/kg NVP syrup at each intake * AZT syrup 4 mg/ kg will be given every 12 hours for four weeks (preterm infants less than 30 weeks will be administered 2 mg/kg every 12 hours; preterm 30-35 weeks will receive 2 mg/kg every 12 hours for the first 2 weeks, increased to 3 mg/kg for the next 2 weeks). * 3TC syrup 2 mg/kg every 12 hours for four weeks.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Marc Lallemant, MD · Institut de Recherche pour le Developpement

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-06-30
Completion
2017-03-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511237 on ClinicalTrials.gov