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Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Institut de Recherche pour le Developpement
Sponsor:
Collaborators:
Global Fund
Ministry of Health, Thailand
Information provided by (Responsible Party):
Gonzague Jourdain, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT00433030
First received: February 8, 2007
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

Since 2004, the Thai Ministry of Public Health has massively scaled up antiretroviral treatment programs to provide therapy to more than 80,000 patients with partial support of the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM).

As access to HIV care continues to expand under the universal health coverage system, it is important to document and analyze the efficacy, tolerance, toxicity and acceptability of antiretroviral therapy within pilot treatment programs, to provide evidence based feedback and recommendations to the national program and policy makers.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


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

Estimated Enrollment: 2000
Study Start Date: January 2007
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Detailed Description:

As Thailand is rapidly expanding access to antiretroviral treatments under the universal health coverage system, it is crucial to document and learn from pilot antiretroviral treatment programs, in particular the medical outcomes and logistical, and organizational issues faced by hospital teams and patients in order to adapt the ARV delivery and monitoring system to various local settings.

Specific objectives

  1. Analyze data collected in patients participating in the PHPT antiretroviral treatment program, in accordance to national and international guidelines, with no experimental interventions.
  2. To determine factors associated with treatment outcome including immune status, virologic factors and antiretroviral drugs levels
  3. To study the operational aspects of integrating comprehensive HIV care into the existing care system with regards to new activities generated at the hospital level (counseling, referral systems, biological monitoring), the impact on other health activities, mobilization of human and financial resources, affordability and sustainability.

The population of the study consists of approximately 2,000 consenting HIV-infected patients, including one-third of children, receiving HIV care as part of the GF-ATM or OXFAM Access to Antiretroviral programs, presenting at any of the PHPT network hospitals.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected Adults and Children

Criteria

Inclusion Criteria:

  • Adults and children (children are defined as less than 18 years old) patients are eligible for the inclusion in the cohort if they meet all the following inclusion criteria:

    • Participation in the GFATM or Oxfam Access to Antiretroviral Programs
    • For adults, consent to have their clinical or biological data used for this research study, and willingness to be followed at one of the PHPT network hospitals. For children, caregiver's consent to participate, willingness to bring the child to the scheduled visits for the duration of the treatment, and to have the child's clinical or biological data used for this research study.

Exclusion Criteria:

  • This is an observational study of an access to treatment program, therefore all patients who require treatment and are willing to be followed by the medical team and have their data collected can be enrolled in the study. The only exclusion criteria would be refusal to participate and the discontinuation criteria would be withdrawal of consent.
  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: NCT00433030

Contacts
Contact: Marc Lallemant, MD +66 53819125 ext 0 marc@phpt.org
Contact: Gonzague Jourdain, MD, PhD +66 53819125 ext 0 gonzague.jourdain@ird.fr

Locations
Thailand
Nopparat Rajathanee Hospital Recruiting
Bungkum, Bangkok, Thailand
Contact: Jeerapat Wongchinsri, MD         
Contact: Sadhit Santadusit, MD         
Principal Investigator: Jeerapat Wongchinsri, MD         
Principal Investigator: Sadhit Santadusit, MD         
Bhumibol Adulyadej Hospital Recruiting
Saimai, Bangkok, Thailand
Contact: Sinart Prommas, MD         
Contact: Prapaisri Layangool, MD         
Principal Investigator: Sinart Prommas, MD         
Principal Investigator: Prapaisri Layangool, MD         
Somdej Prapinklao Hospital Recruiting
Samrae, Bangkok, Thailand
Contact: Nithi Ponganant, MD         
Contact: Maneeratn Nantarukchaikul, MD         
Principal Investigator: Nithi Ponganant, MD         
Principal Investigator: Maneeratn Nantarukchaikul, MD         
Chacheongsao Hospital Recruiting
Muang, Chacheongsao, Thailand
Contact: Pakorn Wittayapraparat, MD         
Contact: Ratchanee Kwanchaipanich, MD         
Principal Investigator: Pakorn Wittayapraparat, MD         
Principal Investigator: Ratchanee Kwanchaipanich, MD         
Prapokklao Hospital Recruiting
Muang, Chantaburi, Thailand
Contact: Malee Techapornroong, MD         
Contact: Chaiwat Ngampiyaskul, MD         
Principal Investigator: Malee Techapornroong, MD         
Principal Investigator: Chaiwat Ngampiyaskul, MD         
Doi Saket Hospital Recruiting
Doi Saket, Chiang Mai, Thailand
Contact: Preecha Sirichithaporn, MD         
Principal Investigator: Preecha Sirichithaporn, MD         
Mae on Hospital Recruiting
Mae on, Chiang Mai, Thailand
Contact: Nopporn Pattanapornpun, MD         
Principal Investigator: Nopporn Pattanapornpun, MD         
Nakornping Hospital Recruiting
Mae Rim, Chiang Mai, Thailand
Contact: Prattana Leenasirimakul, MD         
Contact: Suparat Kanjanavanit, MD         
Principal Investigator: Prattana Leenasirimakul, MD         
Principal Investigator: Suparat Kanjanavanit, MD         
San Sai Hospital Recruiting
San Sai, Chiang Mai, Thailand
Contact: Worawut Cowatcharagul, MD         
Principal Investigator: Worawut Cowatcharagul, MD         
Sankhampang Hospital Recruiting
Sankhampang, Chiang Mai, Thailand
Contact: Narongdate Pipustanawong, MD         
Principal Investigator: Narongdate Pipustanawong, MD         
Sanpatong Hospital Recruiting
Sanpatong, Chiang Mai, Thailand
Contact: Virat Klinbuayaem, MD         
Contact: Noppadon Akarathum, MD         
Principal Investigator: Virat Klinbuayaem, MD         
Principal Investigator: Noppadon Akarathum, MD         
Mae Chan Hospital Recruiting
Mae Chan, Chiang Rai, Thailand
Contact: Sudanee Buranabanjasatean, MD         
Principal Investigator: Sudanee Buranabanjasatean, MD         
Mae Sai Hospital Recruiting
Mae Sai, Chiang Rai, Thailand
Contact: Sura Kunkongkapan, MD         
Principal Investigator: Sura Kunkongkapan, MD         
Phan Hospital Recruiting
Phan, Chiang Rai, Thailand
Contact: Sivaporn Jungpichanvanich, MD         
Principal Investigator: Sivaporn Jungpichanvanich, MD         
Chiangrai Prachanukroh Hospital Recruiting
Muang, Chiangrai, Thailand
Contact: Pacharee Kantipong, MD         
Contact: Rawiwan Hansudewechakul, MD         
Principal Investigator: Pacharee Kantipong, MD         
Principal Investigator: Rawiwan Hansudewechakul, MD         
Chonburi Hospital Recruiting
Muang, Chonburi, Thailand
Contact: Chureeratana Bowonwatanuwong, MD         
Contact: Suchat Hongsiriwon, MD         
Principal Investigator: Chureeratana Bowonwatanuwong, MD         
Principal Investigator: Suchat Hongsiriwon, MD         
Somdej Pranangchao Sirikit Hospital Recruiting
Sattaheep, Chonburi, Thailand
Contact: Vichien Attakornvattana, MD         
Contact: Temsiri Hinjiranandana, MD         
Principal Investigator: Vichien Attakornvattana, MD         
Principal Investigator: Temsiri Hinjiranandana, MD         
Kalasin Hospital Recruiting
Muang, Kalasin, Thailand
Contact: Pramual Thaingamsilp, MD         
Contact: Sakulrat Srirojana, MD         
Principal Investigator: Pramual Thaingamsilp, MD         
Principal Investigator: Sakulrat Srirojana, MD         
Phaholpolphayuhasena Hospital Recruiting
Muang, Kanjanaburi, Thailand
Contact: Patinun Chirawatthanaphan, MD         
Contact: Pornsawan Attavijtrakarn, MD         
Principal Investigator: Patinun Chirawatthanaphan, MD         
Principal Investigator: Pornsawan Attavijtrakarn, MD         
Kranuan Crown Prince Hospital Recruiting
Kranuan, Khon Kaen, Thailand
Contact: Ruangyot Thongdej, MD         
Principal Investigator: Ruangyot Thongdej, MD         
Khon Kaen Hospital Recruiting
Muang, Khon Kaen, Thailand
Contact: Janyaporn Ratanakosol, MD         
Contact: Woranart Chandrakachorn, MD         
Principal Investigator: Janyaporn Ratanakosol, MD         
Principal Investigator: Woranart Chandrakachorn, MD         
Regional Health Promotion Centre 6, Khon Kaen Recruiting
Muang, Khon Kaen, Thailand
Contact: Narong Winiyakul, MD         
Contact: Sansanee Hanpinitsak, MD         
Principal Investigator: Narong Winiyakul, MD         
Principal Investigator: Sansanee Hanpinitsak, MD         
Lampang Hospital Recruiting
Muang, Lampang, Thailand
Contact: Panita Pathipvanich, MD         
Principal Investigator: Panita Pathipvanich, MD         
Lamphun Hospital Recruiting
Muang, Lamphun, Thailand
Contact: Nuananong Luakamlung, MD         
Contact: Pornphun Wannarit, MD         
Principal Investigator: Nuananong Luakamlung, MD         
Principal Investigator: Pornphun Wannarit, MD         
Mahasarakam Hospital Recruiting
Muang, Mahasarakam, Thailand
Contact: Chalongchai Thundee, MD         
Contact: Sathaporn Na-Rajsima, MD         
Principal Investigator: Chalongchai Thundee, MD         
Principal Investigator: Sathaporn Na-Rajsima, MD         
Nakhonpathom Hospital Recruiting
Muang, Nakhonpathom, Thailand
Contact: Rapat Pittayanon, MD         
Contact: Suthunya Bunjongpak, MD         
Principal Investigator: Rapat Pittayanon, MD         
Principal Investigator: Suthunya Bunjongpak, MD         
Maharaj Nakornratchasrima Hospital Recruiting
Muang, Nakornratchasrima, Thailand
Contact: Rittha Lertkoonalak, MD         
Principal Investigator: Rittha Lertkoonalak, MD         
Nong Khai Hospital Recruiting
Muang, Nong Khai, Thailand
Contact: Naruepon Yutthakasemsunt, MD         
Contact: Sathit Potchalongsin, MD         
Principal Investigator: Naruepon Yutthakasemsunt, MD         
Principal Investigator: Sathit Potchalongsin, MD         
Pranangklao Hospital Recruiting
Muang, Nonthaburi, Thailand
Contact: Surachai Pipatnakulchai, MD         
Contact: Sudarat Watanayothin, MD         
Principal Investigator: Surachai Pipatnakulchai, MD         
Principal Investigator: Sudarat Watanayothin, MD         
Chiang Kham Hospital Recruiting
Chiang Kham, Phayao, Thailand
Contact: Yuwadee Buranawanitchakorn, MD         
Principal Investigator: Yuwadee Buranawanitchakorn, MD         
Phayao Provincial Hospital Recruiting
Muang, Phayao, Thailand
Contact: Guttiga Halue, MD         
Contact: Pornchai Techakunakorn, MD         
Principal Investigator: Guttiga Halue, MD         
Principal Investigator: Pornchai Techakunakorn, MD         
Buddhachinaraj Hospital Recruiting
Muang, Pitsanuloke, Thailand
Contact: Somboon Tunsuphasawasdikul, MD         
Contact: Narong Lertpienthum, MD         
Principal Investigator: Somboon Tunsuphasawasdikul, MD         
Principal Investigator: Narong Lertpienthum, MD         
Ratchaburi Hospital Recruiting
Muang, Ratchaburi, Thailand
Contact: Pensiriwan Sangargard, MD         
Contact: Samoejai Henpraserttae, MD         
Principal Investigator: Pensiriwan Sangargard, MD         
Principal Investigator: Samoejai Henpraserttae, MD         
Rayong Hospital Recruiting
Muang, Rayong, Thailand
Contact: Sukit Banchongkit, MD         
Contact: Warit Karnchanamayul, MD         
Principal Investigator: Sukit Banchongkit, MD         
Principal Investigator: Warit Karnchanamayul, MD         
Roi-et Hospital Recruiting
Muang, Roi-et, Thailand
Contact: Boonyong Jeerasuwannakul, MD         
Contact: Pornchai Ananpatharachai, MD         
Principal Investigator: Boonyong Jeerasuwannakul, MD         
Principal Investigator: Pornchai Ananpatharachai, MD         
Samutprakarn Hospital Recruiting
Pak Nam, Samutprakarn, Thailand
Contact: Naree Eiamsirikit, MD         
Contact: Achara Puangsombat, MD         
Principal Investigator: Naree Eiamsirikit, MD         
Principal Investigator: Achara Puangsombat, MD         
Samutsakorn Hospital Recruiting
Muang, Samutsakorn, Thailand
Contact: Apichat Chutanunta, MD         
Contact: Pimpraphai Thanasiri, MD         
Principal Investigator: Apichat Chutanunta, MD         
Principal Investigator: Pimpraphai Thanasiri, MD         
Hat Yai Hospital Recruiting
Hat Yai, Songkla, Thailand
Contact: Ampaipith Nilmanat, MD         
Contact: Boonyarat Warachit, MD         
Principal Investigator: Ampaipith Nilmanat, MD         
Principal Investigator: Boonyarat Warachit, MD         
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Global Fund
Ministry of Health, Thailand
Investigators
Principal Investigator: Marc Lallemant, MD Institut de Recherche pour le Developpement
  More Information

Additional Information:
Publications:

Responsible Party: Gonzague Jourdain, Senior Researcher, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT00433030     History of Changes
Other Study ID Numbers: PHPT-Cohort
Study First Received: February 8, 2007
Last Updated: February 19, 2013
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Institut de Recherche pour le Developpement:
Highly Active Antiretroviral Therapy
HIV Viral load
HIV drug Resistance
Thailand

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

ClinicalTrials.gov processed this record on November 24, 2014