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:
Institut de Recherche pour le Developpement
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
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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) |
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
- Analyze data collected in patients participating in the PHPT antiretroviral treatment program, in accordance to national and international guidelines, with no experimental interventions.
- To determine factors associated with treatment outcome including immune status, virologic factors and antiretroviral drugs levels
- 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
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 |
ClinicalTrials.gov processed this record on March 03, 2015