Trial record 5 of 46 for:
Prevention of mother-to-child transmission OR PMTCT OR MTCT OR perinatal transmission OR vertical transmission | Open Studies | HIV
Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers (PHPT-5)
This study is currently recruiting participants.
Verified February 2013 by Institut de Recherche pour le Developpement
Sponsor:
Institut de Recherche pour le Developpement
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
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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):
The standard of care in Thailand is defined as:
|
Drug: Nevirapine, zidovudine, lamivudine
|
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
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 Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus 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 May 22, 2013