NCT01511237

Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers

PHPT-5 Second Phase: Perinatal Antiretroviral Intensification for the Prevention of Mother-to-child Transmission of HIV in Thai Women Having Received Less Than 8 Weeks of HAART During Pregnancy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 379 (actual)
• Sponsor: Institut de Recherche pour le Developpement · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Design: a multicenter, phase III, single-arm trial. Perinatal antiretroviral intensification (study treatment) is defined as the addition to the standard of care\* for mothers and infants of: * 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. * The standard of care in Thailand is defined as: * Maternal antiretroviral treatment: ZDV 300 mg, 3TC 150mg and LPV/r 400/100 twice a day starting as soon possible after 14 weeks of pregnancy + ZDV 300 mg every 3 hours during labor; this treatment may be continued, stopped or modified after delivery upon the recommendation of the internist. * Newborn: ZDV 4 mg/kg every 12 hours for 4 weeks (ZDV dosing adjusted for premature infants).

Conditions

• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-06-01
• Completion: 2017-03-01
• First posted: 2012-01-18
• Last updated: 2021-10-22

Locations

36 sites across 1 country: Thailand