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Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers (PHPT-5)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Nevirapine, zidovudine, lamivudine
Sponsored by
Institut de Recherche pour le Developpement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV-1 infection, Prophylaxis, Mother-to-child transmission HIV-1, Thailand, Developing Countries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Eligibility. Pregnant women presenting at the prenatal clinics will be eligible if they are confirmed HIV-infected, intend to deliver and bring their infant to a study site for postnatal care for at least 6 months; at least 18 years old; and have given written informed consent to participate in the study, regardless of their CD4 cell count.

Maternal inclusion criteria:

  • 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

Exclusion Criteria:

  • Evidence of pre-existing fetal anomalies incompatible with life;
  • Concurrent participation to any other clinical trial without prior agreement of the two study teams

Sites / Locations

  • Prapokklao Hospital
  • Chomthong Hospital
  • Fang Hospital
  • Nakornping Hospital
  • Sanpatong Hospital
  • Mae Chan Hospital
  • Phan Hospital
  • Chiangrai Prachanukroh Hospital
  • Wiangpapao Hospital
  • Chiang Saen Hospital
  • Banglamung Hospital
  • Chonburi Hospital
  • Panasnikom Hospital
  • Mahasarakam Hospital
  • Nakhonpathom Hospital
  • Chiang Kham Hospital
  • Buddhachinaraj Hospital
  • Samutprakarn Hospital
  • Samutsakhon Hospital
  • Hat Yai Hospital
  • Bhumibol Adulyadej Hospital
  • Nopparat Rajathanee Hospital
  • Bhuddasothorn Hospital
  • Health Promotion Center Region 10, Chiang Mai
  • Kalasin Hospital
  • Khon Kaen Hospital
  • Regional Health Promotion Centre 6, Khon Kaen
  • Lampang Hospital
  • Lamphun Hospital
  • Maharaj Nakhon Si Thammarat Hospital
  • Nong Khai Hospital
  • Pranangklao Hospital
  • Phayao Provincial Hospital
  • Vachira Phuket Hospital
  • Rayong Hospital
  • Songkhla Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perinatal intensification

Arm Description

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).

Outcomes

Primary Outcome Measures

Rate of perinatal HIV transmission
HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age

Secondary Outcome Measures

Safety for women and neonates
All grade 3 and 4 clinical adverse events and abnormal laboratory values in women will be recorded and graded according to the toxicity tables developed by the DAIDS
Pregnancy outcomes
Evaluation of the rates of live births and stillbirths, as well as birth weight, gestational age at delivery according to the results of the sonogram at first prenatal visit, newborn maturity (Ballard score).

Full Information

First Posted
January 10, 2012
Last Updated
October 20, 2021
Sponsor
Institut de Recherche pour le Developpement
Collaborators
Harvard School of Public Health (HSPH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01511237
Brief Title
Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers
Acronym
PHPT-5
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherche pour le Developpement
Collaborators
Harvard School of Public Health (HSPH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1 infection, Prophylaxis, Mother-to-child transmission HIV-1, Thailand, Developing Countries

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
379 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perinatal intensification
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Nevirapine, zidovudine, lamivudine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of perinatal HIV transmission
Description
HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety for women and neonates
Description
All grade 3 and 4 clinical adverse events and abnormal laboratory values in women will be recorded and graded according to the toxicity tables developed by the DAIDS
Time Frame
Up to 12 Months
Title
Pregnancy outcomes
Description
Evaluation of the rates of live births and stillbirths, as well as birth weight, gestational age at delivery according to the results of the sonogram at first prenatal visit, newborn maturity (Ballard score).
Time Frame
Up to 12 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility. Pregnant women presenting at the prenatal clinics will be eligible if they are confirmed HIV-infected, intend to deliver and bring their infant to a study site for postnatal care for at least 6 months; at least 18 years old; and have given written informed consent to participate in the study, regardless of their CD4 cell count. Maternal inclusion criteria: 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 Exclusion Criteria: Evidence of pre-existing fetal anomalies incompatible with life; Concurrent participation to any other clinical trial without prior agreement of the two study teams
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Lallemant, MD
Organizational Affiliation
Institut de Recherche pour le Developpment
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prapokklao Hospital
City
Chanthaburi
State/Province
Chantaburi
ZIP/Postal Code
22000
Country
Thailand
Facility Name
Chomthong Hospital
City
Chom Thong
State/Province
Chiang Mai
ZIP/Postal Code
50160
Country
Thailand
Facility Name
Fang Hospital
City
Fang
State/Province
Chiang Mai
ZIP/Postal Code
50110
Country
Thailand
Facility Name
Nakornping Hospital
City
Mae Rim
State/Province
Chiang Mai
ZIP/Postal Code
50180
Country
Thailand
Facility Name
Sanpatong Hospital
City
San Pa Tong
State/Province
Chiang Mai
ZIP/Postal Code
50120
Country
Thailand
Facility Name
Mae Chan Hospital
City
Mae Chan
State/Province
Chiang Rai
ZIP/Postal Code
57110
Country
Thailand
Facility Name
Phan Hospital
City
Phan
State/Province
Chiang Rai
ZIP/Postal Code
57120
Country
Thailand
Facility Name
Chiangrai Prachanukroh Hospital
City
Chiang Rai
State/Province
Chiangrai
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Wiangpapao Hospital
City
Chiang Rai
State/Province
Chiangrai
ZIP/Postal Code
57170
Country
Thailand
Facility Name
Chiang Saen Hospital
City
Chiang Saen
State/Province
Chiangrai
ZIP/Postal Code
57150
Country
Thailand
Facility Name
Banglamung Hospital
City
Bang Lamung
State/Province
Chonburi
ZIP/Postal Code
20150
Country
Thailand
Facility Name
Chonburi Hospital
City
Chon Buri
State/Province
Chonburi
ZIP/Postal Code
20000
Country
Thailand
Facility Name
Panasnikom Hospital
City
Chon Buri
State/Province
Chonburi
ZIP/Postal Code
20140
Country
Thailand
Facility Name
Mahasarakam Hospital
City
Maha Sarakham
State/Province
Mahasarakam
ZIP/Postal Code
44000
Country
Thailand
Facility Name
Nakhonpathom Hospital
City
Nakhon Pathom
State/Province
Nakhonpathom
ZIP/Postal Code
73000
Country
Thailand
Facility Name
Chiang Kham Hospital
City
Chiang Kham
State/Province
Phayao
ZIP/Postal Code
56110
Country
Thailand
Facility Name
Buddhachinaraj Hospital
City
Phitsanulok
State/Province
Pitsanuloke
ZIP/Postal Code
65000
Country
Thailand
Facility Name
Samutprakarn Hospital
City
Samut Prakan
State/Province
Samutprakarn
ZIP/Postal Code
10280
Country
Thailand
Facility Name
Samutsakhon Hospital
City
Samut Sakhon
State/Province
Samutsakhon
ZIP/Postal Code
74000
Country
Thailand
Facility Name
Hat Yai Hospital
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Bhumibol Adulyadej Hospital
City
Bangkok
ZIP/Postal Code
10220
Country
Thailand
Facility Name
Nopparat Rajathanee Hospital
City
Bangkok
ZIP/Postal Code
10230
Country
Thailand
Facility Name
Bhuddasothorn Hospital
City
Chachoengsao
ZIP/Postal Code
24000
Country
Thailand
Facility Name
Health Promotion Center Region 10, Chiang Mai
City
Chiang Mai
ZIP/Postal Code
50100
Country
Thailand
Facility Name
Kalasin Hospital
City
Kalasin
ZIP/Postal Code
46000
Country
Thailand
Facility Name
Khon Kaen Hospital
City
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand
Facility Name
Regional Health Promotion Centre 6, Khon Kaen
City
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand
Facility Name
Lampang Hospital
City
Lampang
ZIP/Postal Code
52000
Country
Thailand
Facility Name
Lamphun Hospital
City
Lamphun
ZIP/Postal Code
51000
Country
Thailand
Facility Name
Maharaj Nakhon Si Thammarat Hospital
City
Nakhon Si Thammarat
ZIP/Postal Code
80000
Country
Thailand
Facility Name
Nong Khai Hospital
City
Nong Khai
ZIP/Postal Code
43000
Country
Thailand
Facility Name
Pranangklao Hospital
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Phayao Provincial Hospital
City
Phayao
ZIP/Postal Code
56000
Country
Thailand
Facility Name
Vachira Phuket Hospital
City
Phuket
ZIP/Postal Code
83000
Country
Thailand
Facility Name
Rayong Hospital
City
Rayong
ZIP/Postal Code
21000
Country
Thailand
Facility Name
Songkhla Hospital
City
Songkhla
ZIP/Postal Code
90100
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
28489732
Citation
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 Reference
background
Citation
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 Reference
result
PubMed Identifier
32205720
Citation
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.
Results Reference
result
Links:
URL
http://www.clinicaltrials.gov/ct2/show/NCT00409591
Description
PHPT-5 First Phase

Learn more about this trial

Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers

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