Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers

PHASE3CompletedINTERVENTIONAL
Enrollment

379

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

June 30, 2015

Study Completion Date

March 31, 2017

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."

Trial Locations (36)

10220

Bhumibol Adulyadej Hospital, Bangkok

10230

Nopparat Rajathanee Hospital, Bangkok

10280

Samutprakarn Hospital, Mueang Samut Prakan

11000

Pranangklao Hospital, Nonthaburi

20000

Chonburi Hospital, Chon Buri

20140

Panasnikom Hospital, Chon Buri

20150

Banglamung Hospital, Bang Lamung

21000

Rayong Hospital, Rayong

22000

Prapokklao Hospital, Chanthaburi

24000

Bhuddasothorn Hospital, Chachoengsao

40000

Khon Kaen Hospital, Khon Kaen

Regional Health Promotion Centre 6, Khon Kaen, Khon Kaen

43000

Nong Khai Hospital, Nong Khai

44000

Mahasarakam Hospital, Maha Sarakham

46000

Kalasin Hospital, Kalasin

50100

Health Promotion Center Region 10, Chiang Mai, Chiang Mai

50110

Fang Hospital, Fang

50120

Sanpatong Hospital, San Pa Tong

50160

Chomthong Hospital, Chom Thong

50180

Nakornping Hospital, Mae Rim

51000

Lamphun Hospital, Lamphun

52000

Lampang Hospital, Lampang

56000

Phayao Provincial Hospital, Phayao

56110

Chiang Kham Hospital, Chiang Kham

57000

Chiangrai Prachanukroh Hospital, Chiang Rai

57110

Mae Chan Hospital, Mae Chan

57120

Phan Hospital, Phan

57150

Chiang Saen Hospital, Chiang Saen

57170

Wiangpapao Hospital, Chiang Rai

65000

Buddhachinaraj Hospital, Phitsanulok

73000

Nakhonpathom Hospital, Nakhon Pathom

74000

Samutsakhon Hospital, Samut Sakhon

80000

Maharaj Nakhon Si Thammarat Hospital, Nakhon Si Thammarat

83000

Vachira Phuket Hospital, Phuket

90100

Songkhla Hospital, Songkhla

90110

Hat Yai Hospital, Hat Yai

All Listed Sponsors
collaborator

Harvard School of Public Health (HSPH)

OTHER

collaborator

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

NIH

lead

Institut de Recherche pour le Developpement

OTHER_GOV

NCT01511237 - Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers | Biotech Hunter | Biotech Hunter