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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Institut de Recherche pour le Developpement
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: February 10, 2013
Last verified: February 2013
  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

Contacts
Contact: Marc Lallemant, MD 66 53 819 125-9 marc@phpt.org
Contact: Gonzague Jourdain, MD 66 53 819 125-9 ext 310 gonzague.jourdain@phpt.org

Locations
Thailand
Health Promotion Hospital Regional Center I Not yet recruiting
Bangkean, Bangkok, Thailand, 10220
Contact: Somsak Wachirachaikan, MD       drsak@yahoo.com   
Principal Investigator: Somsak Wachirachaikan, MD         
Principal Investigator: Surat Sirinontakan, MD         
Nopparat Rajathanee Hospital Not yet recruiting
Kannayao, Bangkok, Thailand, 10230
Contact: Boonsong Rawangban, MD       boonsongrwb@gmail.com   
Principal Investigator: Boonsong Rawangban, MD         
Principal Investigator: Sadhit Santadusit, MD         
Bhumibol Adulyadej Hospital Not yet recruiting
Saimai, Bangkok, Thailand, 10220
Contact: Sinart Prommas, MD       nprommas@gmail.com   
Principal Investigator: Sinart Prommas, MD         
Principal Investigator: Prapaisri Layangool, MD         
Bhuddasothorn Hospital Not yet recruiting
Muang, Chachoengsao, Thailand, 24000
Contact: Ratchanee Kwanchaipanich, MD       rutchaneekwan@yahoo.co.th   
Principal Investigator: Annop Kanjanasing, MD         
Principal Investigator: Ratchanee Kwanchaipanich, MD         
Prapokklao Hospital Recruiting
Muang, Chantaburi, Thailand, 22000
Contact: Prapap Yuthavisuthi, MD       yuthavisuthi@gmail.com   
Principal Investigator: Prapap Yuthavisuthi, MD         
Principal Investigator: Chaiwat Ngampiyaskul, MD         
Chomthong Hospital Not yet recruiting
Chomthong, Chiang Mai, Thailand, 50160
Contact: Arunsri Iamthongin, MD       arunsri@cmu3407.com   
Principal Investigator: Arunsri Iamthongin, MD         
Principal Investigator: Apichai Phiyarom, MD         
Fang Hospital Recruiting
Fang, Chiang Mai, Thailand, 50110
Contact: Jantana Jungpipun, MD       juntanaj@yahoo.com   
Principal Investigator: Jantana Jungpipun, MD         
Nakornping Hospital Recruiting
Mae Rim, Chiang Mai, Thailand, 50180
Contact: Suparat Kanjanavanit, MD       skanjanavanit@yahoo.com   
Principal Investigator: Aram Limtrakul, MD         
Principal Investigator: Suparat Kanjanavanit, MD         
Health Promotion Center Region 10, Chiang Mai Recruiting
Muang, Chiang Mai, Thailand, 50100
Contact: Suraphan Sangsawang, MD       suraphan@anamai.moph.go.th   
Principal Investigator: Suraphan Sangsawang, MD         
Principal Investigator: Kanokwan Jittayanun, MD         
Sanpatong Hospital Recruiting
Sanpatong, Chiang Mai, Thailand, 50120
Contact: Prayoon Khamja, MD       Prayoon123@yahoo.com   
Principal Investigator: Prayoon Khamja, MD         
Principal Investigator: Noppadon Akarathum, MD         
Mae Chan Hospital Recruiting
Mae Chan, Chiang Rai, Thailand, 57110
Contact: Surachai Piyaworawong, MD       Maechan_hos@hotmail.com   
Principal Investigator: Surachai Piyaworawong, MD         
Principal Investigator: Sudanee Buranabanjasatean, MD         
Mae Sai Hospital Recruiting
Mae Sai, Chiang Rai, Thailand, 57130
Contact: Premjit Charoenweerakul, MD       jib_081@hotmail.com   
Principal Investigator: Premjit Charoenweerakul, MD         
Principal Investigator: Jariyarat Nitipipatkosol, MD         
Phan Hospital Recruiting
Phan, Chiang Rai, Thailand, 57120
Contact: Sookchai Theansavettrakul, MD       scthean@gmail.com   
Principal Investigator: Sookchai Theansavettrakul, MD         
Chiang Saen Hospital Recruiting
Chiang Saen, Chiangrai, Thailand, 57150
Contact: Ittipol Chaitha, MD       itchaita@yahoo.com   
Principal Investigator: Ittipol Chaitha, MD         
Chiangrai Prachanukroh Hospital Not yet recruiting
Muang, Chiangrai, Thailand, 57000
Contact: Jullapong Achalapong, MD       drjullapong@yahoo.com   
Principal Investigator: Jullapong Achalapong, MD         
Principal Investigator: Rawiwan Hansudewechakul, MD         
Wiangpapao Hospital Recruiting
Wiangpapao, Chiangrai, Thailand, 57170
Contact: Toranong Pilalai, MD       pingpopular@hotmail.com   
Principal Investigator: Toranong Pilalai, MD         
Banglamung Hospital Recruiting
Banglamung, Chonburi, Thailand, 20150
Contact: Prateep Kanjanavikai, MD       pk2525_2525@hotmail.com   
Principal Investigator: Prateep Kanjanavikai, MD         
Principal Investigator: Siriluk Phanomcheong, MD         
Chonburi Hospital Recruiting
Muang, Chonburi, Thailand, 20000
Contact: Nantasak Chotivanich, MD       nantasak.cho@gmail.com   
Principal Investigator: Nantasak Chotivanich, MD         
Principal Investigator: Suchat Hongsiriwon, MD         
Panasnikom Hospital Recruiting
Panasnikom, Chonburi, Thailand, 20140
Contact: Manoch Chakorngowit, MD       manocha9@hotmail.com   
Principal Investigator: Manoch Chakorngowit, MD         
Principal Investigator: Wisith Pholsawat, MD         
Kalasin Hospital Not yet recruiting
Muang, Kalasin, Thailand, 46000
Contact: Sakulrat Srirojana, MD       sakulrats@yahoo.com   
Principal Investigator: Bunpode Suwannachat, MD         
Principal Investigator: Sakulrat Srirojana, MD         
Khon Kaen Hospital Not yet recruiting
Muang, Khon Kaen, Thailand, 40000
Contact: Thitiporn Siriwachirachai, MD       siriwachirachai@hotmail.com   
Principal Investigator: Thitiporn Siriwachirachai, MD         
Principal Investigator: Sirijitt Wasanawatna, MD         
Regional Health Promotion Centre 6, Khon Kaen Not yet recruiting
Muang, Khon Kaen, Thailand, 40000
Contact: Kraisorn Vivatpatanakul, MD       ks2496@yahoo.com   
Principal Investigator: Kraisorn Vivatpatanakul, MD         
Principal Investigator: Sansanee Hanpinitsak, MD         
Lampang Hospital Recruiting
Muang, Lampang, Thailand, 52000
Contact: Prateung Liampongsabuddhi, MD       prateung@yahoo.com   
Principal Investigator: Prateung Liampongsabuddhi, MD         
Principal Investigator: Kultida Pongdetudom, MD         
Lamphun Hospital Recruiting
Muang, Lamphun, Thailand, 51000
Contact: Wanmanee Matanasarawut, MD       obgyn.lph@gmail.com   
Principal Investigator: Wanmanee Matanasarawut, MD         
Principal Investigator: Pornpun Wannarit, MD         
Mahasarakam Hospital Not yet recruiting
Muang, Mahasarakam, Thailand, 44000
Contact: Sathaporn Na-Rajsima, MD       sathapongpong@yahoo.com   
Principal Investigator: Worapong Worachet, MD         
Principal Investigator: Sathaporn Na-Rajsima, MD         
Maharaj Nakhon Si Thammarat Hospital Not yet recruiting
Muang, Nakhon Si Thammarat, Thailand, 80000
Contact: Sukit Mahattanan, MD       sukit73@gmail.com   
Principal Investigator: Sukit Mahattanan, MD         
Principal Investigator: Somsri Kotchawet, MD         
Nakhonpathom Hospital Not yet recruiting
Muang, Nakhonpathom, Thailand, 73000
Contact: Rucha Kongpanichkul, MD       ruchakong@gmail.com   
Principal Investigator: Rucha Kongpanichkul, MD         
Principal Investigator: Suthunya Bunjongpak, MD         
Nong Khai Hospital Not yet recruiting
Muang, Nong Khai, Thailand, 43000
Contact: Noossara Puarattana.aroonkorn, MD       nusra2497@hotmail.com   
Principal Investigator: Noossara Puarattana.aroonkorn, MD         
Principal Investigator: Sathit Potchalongsin, MD         
Pranangklao Hospital Not yet recruiting
Muang, Nonthaburi, Thailand, 11000
Contact: Surachai Pipatnakulchai, MD    +66 (0) 2 527 0246 ext 8410      
Principal Investigator: Surachai Pipatnakulchai, MD         
Principal Investigator: Sinchai Wanwaisart, MD         
Chiang Kham Hospital Recruiting
Chiang Kham, Phayao, Thailand, 56110
Contact: Chaiwat Putiyanun, MD       putiyanun@hotmail.com   
Principal Investigator: Chaiwat Putiyanun, MD         
Principal Investigator: Vanichaya Wanchaitanawong, MD         
Phayao Provincial Hospital Recruiting
Muang, Phayao, Thailand, 56000
Contact: Jittapol Hemvuttiphan, MD       jittapolh@gmail.com   
Principal Investigator: Jittapol Hemvuttiphan, MD         
Principal Investigator: Pornchai Techakunakorn, MD         
Vachira Phuket Hospital Not yet recruiting
Muang, Phuket, Thailand, 83000
Contact: Weerasak Lawtongkum, MD       lawtongum@gmail.com   
Principal Investigator: Sompong Wannun, MD         
Principal Investigator: Weerasak Lawtongkum, MD         
Buddhachinaraj Hospital Not yet recruiting
Muang, Pitsanuloke, Thailand, 65000
Contact: Kanchapan Sukonpan, MD       puimfm@gmail.com   
Principal Investigator: Kanchapan Sukonpan, MD         
Principal Investigator: Narong Lertpienthum, MD         
Rayong Hospital Recruiting
Muang, Rayong, Thailand, 21000
Contact: Weerapong Suwankornsakul, MD       weerapong14@hotmail.com   
Principal Investigator: Weerapong Suwankornsakul, MD         
Principal Investigator: Warit Karnchanamayul, MD         
Samutprakarn Hospital Recruiting
Muang, Samutprakarn, Thailand, 10280
Contact: Prapan Sabsanong, MD       prapandr@hotmail.com   
Principal Investigator: Prapan Sabsanong, MD         
Principal Investigator: Wantana Likhitwisetkul, MD         
Samutsakhon Hospital Recruiting
Muang, Samutsakhon, Thailand, 74000
Contact: Sawitree Krikajornkitti, MD       yuiwitree@gmail.com   
Principal Investigator: Supang Varadisai, MD         
Principal Investigator: Sawitree Krikajornkitti, MD         
Songkhla Hospital Not yet recruiting
Muangsongkhla, Songkhla, Thailand, 90100
Contact: Supha-arth Phon-in, MD       suphaar@sk-hospital.com   
Principal Investigator: Supha-arth Phon-in, MD         
Principal Investigator: Wannee Limpitikul, MD         
Hat Yai Hospital Not yet recruiting
Hat Yai, Songkla, Thailand, 90110
Contact: Surachai Lamlertkittikul, MD       surachai.la@hotmail.com   
Principal Investigator: Surachai Lamlertkittikul, MD         
Principal Investigator: Boonyarat Warachit, MD         
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: February 10, 2013
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
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
Zidovudine
Nevirapine
Lamivudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 10, 2014