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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Harvard School of Public Health
Information provided by (Responsible Party):
Marc Lallemant, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT01511237
First received: January 10, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nevirapine, zidovudine, lamivudine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:
  • Rate of perinatal HIV transmission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age


Secondary Outcome Measures:
  • Safety for women and neonates [ Time Frame: Up to 12 Months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 1837
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511237

Locations
Thailand
Health Promotion Hospital Regional Center I
Bangkean, Bangkok, Thailand, 10220
Nopparat Rajathanee Hospital
Kannayao, Bangkok, Thailand, 10230
Bhumibol Adulyadej Hospital
Saimai, Bangkok, Thailand, 10220
Bhuddasothorn Hospital
Muang, Chachoengsao, Thailand, 24000
Prapokklao Hospital
Muang, Chantaburi, Thailand, 22000
Chomthong Hospital
Chomthong, Chiang Mai, Thailand, 50160
Fang Hospital
Fang, Chiang Mai, Thailand, 50110
Nakornping Hospital
Mae Rim, Chiang Mai, Thailand, 50180
Health Promotion Center Region 10, Chiang Mai
Muang, Chiang Mai, Thailand, 50100
Sanpatong Hospital
Sanpatong, Chiang Mai, Thailand, 50120
Mae Chan Hospital
Mae Chan, Chiang Rai, Thailand, 57110
Mae Sai Hospital
Mae Sai, Chiang Rai, Thailand, 57130
Phan Hospital
Phan, Chiang Rai, Thailand, 57120
Chiang Saen Hospital
Chiang Saen, Chiangrai, Thailand, 57150
Chiangrai Prachanukroh Hospital
Muang, Chiangrai, Thailand, 57000
Wiangpapao Hospital
Wiangpapao, Chiangrai, Thailand, 57170
Banglamung Hospital
Banglamung, Chonburi, Thailand, 20150
Chonburi Hospital
Muang, Chonburi, Thailand, 20000
Panasnikom Hospital
Panasnikom, Chonburi, Thailand, 20140
Kalasin Hospital
Muang, Kalasin, Thailand, 46000
Khon Kaen Hospital
Muang, Khon Kaen, Thailand, 40000
Regional Health Promotion Centre 6, Khon Kaen
Muang, Khon Kaen, Thailand, 40000
Lampang Hospital
Muang, Lampang, Thailand, 52000
Lamphun Hospital
Muang, Lamphun, Thailand, 51000
Mahasarakam Hospital
Muang, Mahasarakam, Thailand, 44000
Maharaj Nakhon Si Thammarat Hospital
Muang, Nakhon Si Thammarat, Thailand, 80000
Nakhonpathom Hospital
Muang, Nakhonpathom, Thailand, 73000
Nong Khai Hospital
Muang, Nong Khai, Thailand, 43000
Pranangklao Hospital
Muang, Nonthaburi, Thailand, 11000
Chiang Kham Hospital
Chiang Kham, Phayao, Thailand, 56110
Phayao Provincial Hospital
Muang, Phayao, Thailand, 56000
Vachira Phuket Hospital
Muang, Phuket, Thailand, 83000
Buddhachinaraj Hospital
Muang, Pitsanuloke, Thailand, 65000
Rayong Hospital
Muang, Rayong, Thailand, 21000
Samutprakarn Hospital
Muang, Samutprakarn, Thailand, 10280
Samutsakhon Hospital
Muang, Samutsakhon, Thailand, 74000
Songkhla Hospital
Muangsongkhla, Songkhla, Thailand, 90100
Hat Yai Hospital
Hat Yai, Songkla, Thailand, 90110
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Harvard School of Public Health
Investigators
Principal Investigator: Marc Lallemant, MD Institut de Recherche pour le Developpment
  More Information

Additional Information:
No publications provided

Responsible Party: Marc Lallemant, Senior Researcher, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT01511237     History of Changes
Other Study ID Numbers: PHPT-5 Second Phase, R01HD052461, R01HD056953
Study First Received: January 10, 2012
Last Updated: July 24, 2014
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Institut de Recherche pour le Developpement:
HIV-1 infection
Prophylaxis
Mother-to-child transmission HIV-1
Thailand
Developing Countries

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014