drugset / Trial / NCT01511237
Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers
Phase 3
Completed
379 enrolled
Research Institute for Development
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabHarvard School of Public Health (HSPH) · collab
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2011-12
- Primary completion
- 2015-06
- Completion
- 2017-03
Publications
- Background 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | 2 mg/kg | — |
| Subject | Lamivudine | Other / unclassified | 150 mg | — |
| Subject | Nevirapine | Small molecule | 2 mg/kg | — |
| Subject | Nevirapine | Small molecule | 4 mg/kg | — |
| Subject | Nevirapine | Small molecule | 200 mg | — |
| Subject | Zidovudine | Small molecule | 2 mg/kg | — |
| Subject | Zidovudine | Small molecule | 3 mg/kg | — |
| Subject | Zidovudine | Small molecule | 4 mg/kg | — |
| Subject | Zidovudine | Small molecule | 300 mg | — |