Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    PHPT5
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01511237
Recruitment Status : Unknown
Verified November 2016 by Marc Lallemant, Institut de Recherche pour le Developpement.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2012
Last Update Posted : November 8, 2016
Sponsor:
Collaborators:
Harvard School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Marc Lallemant, Institut de Recherche pour le Developpement

Tracking Information
First Submitted Date  ICMJE January 10, 2012
First Posted Date  ICMJE January 18, 2012
Last Update Posted Date November 8, 2016
Study Start Date  ICMJE December 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
Rate of perinatal HIV transmission [ Time Frame: 6 months ]
HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01511237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
  • Safety for women and neonates [ Time Frame: Up to 12 Months ]
    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 [ Time Frame: Up to 12 Months ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 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).
Intervention: Drug: Nevirapine, zidovudine, lamivudine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2012)
1837
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01511237
Other Study ID Numbers  ICMJE PHPT-5 Second Phase
R01HD052461 ( U.S. NIH Grant/Contract )
R01HD056953 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc Lallemant, Institut de Recherche pour le Developpement
Study Sponsor  ICMJE Institut de Recherche pour le Developpement
Collaborators  ICMJE
  • Harvard School of Public Health
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Marc Lallemant, MD Institut de Recherche pour le Developpment
PRS Account Institut de Recherche pour le Developpement
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP