Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers
PHPT-5
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
3 other identifiers
interventional
379
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Dec 2011
Longer than P75 for phase_3 hiv-infections
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
January 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedOctober 22, 2021
October 1, 2021
3.5 years
January 10, 2012
October 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of perinatal HIV transmission
HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age
6 months
Secondary Outcomes (2)
Safety for women and neonates
Up to 12 Months
Pregnancy outcomes
Up to 12 Months
Study Arms (1)
Perinatal intensification
EXPERIMENTALPerinatal 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).
Interventions
* 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
You may qualify if:
- Evidence of HIV infection, as documented by two serology tests obtained at two different dates;
- 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
You may not qualify if:
- Evidence of pre-existing fetal anomalies incompatible with life;
- Concurrent participation to any other clinical trial without prior agreement of the two study teams
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Prapokklao Hospital
Chanthaburi, Changwat Chanthaburi, 22000, Thailand
Mae Chan Hospital
Mae Chan, Changwat Chiang Rai, 57110, Thailand
Phan Hospital
Phan, Changwat Chiang Rai, 57120, Thailand
Banglamung Hospital
Bang Lamung, Changwat Chon Buri, 20150, Thailand
Chonburi Hospital
Chon Buri, Changwat Chon Buri, 20000, Thailand
Panasnikom Hospital
Chon Buri, Changwat Chon Buri, 20140, Thailand
Chiang Kham Hospital
Chiang Kham, Changwat Phayao, 56110, Thailand
Buddhachinaraj Hospital
Phitsanulok, Changwat Phitsanulok, 65000, Thailand
Hat Yai Hospital
Hat Yai, Changwat Songkhla, 90110, Thailand
Chomthong Hospital
Chom Thong, Chiang Mai, 50160, Thailand
Fang Hospital
Fang, Chiang Mai, 50110, Thailand
Nakornping Hospital
Mae Rim, Chiang Mai, 50180, Thailand
Sanpatong Hospital
San Pa Tong, Chiang Mai, 50120, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, Chiangrai, 57000, Thailand
Wiangpapao Hospital
Chiang Rai, Chiangrai, 57170, Thailand
Chiang Saen Hospital
Chiang Saen, Chiangrai, 57150, Thailand
Mahasarakam Hospital
Maha Sarakham, Mahasarakam, 44000, Thailand
Nakhonpathom Hospital
Nakhon Pathom, Nakhonpathom, 73000, Thailand
Samutprakarn Hospital
Mueang Samut Prakan, Samutprakarn, 10280, Thailand
Samutsakhon Hospital
Samut Sakhon, Samutsakhon, 74000, Thailand
Bhumibol Adulyadej Hospital
Bangkok, 10220, Thailand
Nopparat Rajathanee Hospital
Bangkok, 10230, Thailand
Bhuddasothorn Hospital
Chachoengsao, 24000, Thailand
Health Promotion Center Region 10, Chiang Mai
Chiang Mai, 50100, Thailand
Kalasin Hospital
Kalasin, 46000, Thailand
Khon Kaen Hospital
Khon Kaen, 40000, Thailand
Regional Health Promotion Centre 6, Khon Kaen
Khon Kaen, 40000, Thailand
Lampang Hospital
Lampang, 52000, Thailand
Lamphun Hospital
Lamphun, 51000, Thailand
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat, 80000, Thailand
Nong Khai Hospital
Nong Khai, 43000, Thailand
Pranangklao Hospital
Nonthaburi, 11000, Thailand
Phayao Provincial Hospital
Phayao, 56000, Thailand
Vachira Phuket Hospital
Phuket, 83000, Thailand
Rayong Hospital
Rayong, 21000, Thailand
Songkhla Hospital
Songkhla, 90100, Thailand
Related Publications (3)
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.
PMID: 28489732BACKGROUNDLallemant 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.
RESULTLallemant 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.
PMID: 32205720RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Lallemant, MD
Institut de Recherche pour le Developpement
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
January 10, 2012
First Posted
January 18, 2012
Study Start
December 1, 2011
Primary Completion
June 1, 2015
Study Completion
March 1, 2017
Last Updated
October 22, 2021
Record last verified: 2021-10