Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers
NCT ID: NCT01511237
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
379 participants
INTERVENTIONAL
2011-12-31
2017-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Perinatal intensification
Perinatal antiretroviral intensification (study treatment):
* 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
The standard of care in Thailand is defined as:
* Maternal: 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
* Newborn: ZDV 4 mg/kg every 12 hours for 4 weeks (ZDV dosing adjusted for premature infants).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* All HIV infected pregnant women will be enrolled, either in the intervention arm or an observational study group.
* Women more than 30 weeks gestational age at start of antiretroviral treatment will be eligible for the intervention. They will actually receive the study intervention if they present in labor after less than 8 weeks of treatment duration;
* Women with no ANC will receive standard care and will be enrolled in an observational study group(and their infant will receive standard of care perinatal antiretroviral intensification)
* Women with less than 30 weeks gestational age at start of treatment will receive standard care and will also be enrolled in the Observational Reference group;
* Agreement not to breastfeed;
* Consent to participate and to be followed for the duration of the study
Exclusion Criteria
* Concurrent participation to any other clinical trial without prior agreement of the two study teams
18 Years
FEMALE
No
Sponsors
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Harvard School of Public Health (HSPH)
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Institut de Recherche pour le Developpement
OTHER_GOV
Responsible Party
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Marc Lallemant
Senior Researcher
Principal Investigators
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Marc Lallemant, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherche pour le Developpement
Locations
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Prapokklao Hospital
Chanthaburi, Changwat Chanthaburi, Thailand
Mae Chan Hospital
Mae Chan, Changwat Chiang Rai, Thailand
Phan Hospital
Phan, Changwat Chiang Rai, Thailand
Banglamung Hospital
Bang Lamung, Changwat Chon Buri, Thailand
Chonburi Hospital
Chon Buri, Changwat Chon Buri, Thailand
Panasnikom Hospital
Chon Buri, Changwat Chon Buri, Thailand
Chiang Kham Hospital
Chiang Kham, Changwat Phayao, Thailand
Buddhachinaraj Hospital
Phitsanulok, Changwat Phitsanulok, Thailand
Hat Yai Hospital
Hat Yai, Changwat Songkhla, Thailand
Chomthong Hospital
Chom Thong, Chiang Mai, Thailand
Fang Hospital
Fang, Chiang Mai, Thailand
Nakornping Hospital
Mae Rim, Chiang Mai, Thailand
Sanpatong Hospital
San Pa Tong, Chiang Mai, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, Chiangrai, Thailand
Wiangpapao Hospital
Chiang Rai, Chiangrai, Thailand
Chiang Saen Hospital
Chiang Saen, Chiangrai, Thailand
Mahasarakam Hospital
Maha Sarakham, Mahasarakam, Thailand
Nakhonpathom Hospital
Nakhon Pathom, Nakhonpathom, Thailand
Samutprakarn Hospital
Mueang Samut Prakan, Samutprakarn, Thailand
Samutsakhon Hospital
Samut Sakhon, Samutsakhon, Thailand
Bhumibol Adulyadej Hospital
Bangkok, , Thailand
Nopparat Rajathanee Hospital
Bangkok, , Thailand
Bhuddasothorn Hospital
Chachoengsao, , Thailand
Health Promotion Center Region 10, Chiang Mai
Chiang Mai, , Thailand
Kalasin Hospital
Kalasin, , Thailand
Khon Kaen Hospital
Khon Kaen, , Thailand
Regional Health Promotion Centre 6, Khon Kaen
Khon Kaen, , Thailand
Lampang Hospital
Lampang, , Thailand
Lamphun Hospital
Lamphun, , Thailand
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat, , Thailand
Nong Khai Hospital
Nong Khai, , Thailand
Pranangklao Hospital
Nonthaburi, , Thailand
Phayao Provincial Hospital
Phayao, , Thailand
Vachira Phuket Hospital
Phuket, , Thailand
Rayong Hospital
Rayong, , Thailand
Songkhla Hospital
Songkhla, , Thailand
Countries
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References
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Cressey TR, Punyawudho B, Le Coeur S, Jourdain G, Saenjum C, Capparelli EV, Jittayanun K, Phanomcheong S, Luvira A, Borkird T, Puangsombat A, Aarons L, Sukrakanchana PO, Urien S, Lallemant M; PHPT-5 study team. Assessment of Nevirapine Prophylactic and Therapeutic Dosing Regimens for Neonates. J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):554-560. doi: 10.1097/QAI.0000000000001447.
Lallemant Marc, Amzal Billy, Urien Saik, Sripan Patumrat, Cressey Tim R, Ngo-Giang-Huong Nicole, Rawangban Boonsong, Sabsanong Prapan, Siriwachirachai Thitiporn, Jarupanich Tapnarong, Kanjanavikai Prateep, Wanasiri Phaiboon, Koetsawang Suporn, Jourdain Gonzague, Le Cœur Sophie, for the PHPT-5 team. 2015. -"Antiretroviral Intensification to Prevent Intrapartum HIV Transmission in Late Comers". 8th IAS Conference on HIV Pathogenesis Treatment & Prevention, Vancouver, Canada, 19-22 July 2015.
Lallemant M, Amzal B, Sripan P, Urien S, Cressey TR, Ngo-Giang-Huong N, Klinbuayaem V, Rawangban B, Sabsanong P, Siriwachirachai T, Jarupanich T, Kanjanavikai P, Wanasiri P, Koetsawang S, Jourdain G, Le Coeur S; PHPT-5 site investigators. Perinatal Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):313-322. doi: 10.1097/QAI.0000000000002350.
Related Links
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PHPT-5 First Phase
Other Identifiers
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