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

This study is ongoing, but not recruiting participants.
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: May 25, 2015
Last verified: May 2015
  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: 2816
Study Start Date: January 2007
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 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

Locations
Thailand
Nopparat Rajathanee Hospital
Bungkum, Bangkok, Thailand
Bhumibol Adulyadej Hospital
Saimai, Bangkok, Thailand
Somdej Prapinklao Hospital
Samrae, Bangkok, Thailand
Chacheongsao Hospital
Muang, Chacheongsao, Thailand
Prapokklao Hospital
Muang, Chantaburi, Thailand
Doi Saket Hospital
Doi Saket, Chiang Mai, Thailand
Mae on Hospital
Mae on, Chiang Mai, Thailand
Nakornping Hospital
Mae Rim, Chiang Mai, Thailand
San Sai Hospital
San Sai, Chiang Mai, Thailand
Sankhampang Hospital
Sankhampang, Chiang Mai, Thailand
Sanpatong Hospital
Sanpatong, Chiang Mai, Thailand
Mae Chan Hospital
Mae Chan, Chiang Rai, Thailand
Mae Sai Hospital
Mae Sai, Chiang Rai, Thailand
Phan Hospital
Phan, Chiang Rai, Thailand
Chiangrai Prachanukroh Hospital
Muang, Chiangrai, Thailand
Chonburi Hospital
Muang, Chonburi, Thailand
Somdej Pranangchao Sirikit Hospital
Sattaheep, Chonburi, Thailand
Kalasin Hospital
Muang, Kalasin, Thailand
Phaholpolphayuhasena Hospital
Muang, Kanjanaburi, Thailand
Kranuan Crown Prince Hospital
Kranuan, Khon Kaen, Thailand
Khon Kaen Hospital
Muang, Khon Kaen, Thailand
Regional Health Promotion Centre 6, Khon Kaen
Muang, Khon Kaen, Thailand
Lampang Hospital
Muang, Lampang, Thailand
Lamphun Hospital
Muang, Lamphun, Thailand
Mahasarakam Hospital
Muang, Mahasarakam, Thailand
Nakhonpathom Hospital
Muang, Nakhonpathom, Thailand
Maharaj Nakornratchasrima Hospital
Muang, Nakornratchasrima, Thailand
Nong Khai Hospital
Muang, Nong Khai, Thailand
Pranangklao Hospital
Muang, Nonthaburi, Thailand
Chiang Kham Hospital
Chiang Kham, Phayao, Thailand
Phayao Provincial Hospital
Muang, Phayao, Thailand
Buddhachinaraj Hospital
Muang, Pitsanuloke, Thailand
Ratchaburi Hospital
Muang, Ratchaburi, Thailand
Rayong Hospital
Muang, Rayong, Thailand
Roi-et Hospital
Muang, Roi-et, Thailand
Samutprakarn Hospital
Pak Nam, Samutprakarn, Thailand
Samutsakorn Hospital
Muang, Samutsakorn, Thailand
Hat Yai Hospital
Hat Yai, Songkla, Thailand
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Global Fund
Ministry of Health, Thailand
Investigators
Principal Investigator: Gonzague JOURDAIN, MD, PhD Institut de Recherche pour le Developpement
  More Information

Additional Information:
Publications:
Tang MW, Rhee SY, Bertagnolio S, Ford N, Holmes S, Sigaloff KC, Hamers RL, de Wit TF, Fleury HJ, Kanki PJ, Ruxrungtham K, Hawkins CA, Wallis CL, Stevens W, van Zyl GU, Manosuthi W, Hosseinipour MC, Ngo-Giang-Huong N, Belec L, Peeters M, Aghokeng A, Bunupuradah T, Burda S, Cane P, Cappelli G, Charpentier C, Dagnra AY, Deshpande AK, El-Katib Z, Eshleman SH, Fokam J, Gody JC, Katzenstein D, Koyalta DD, Kumwenda JJ, Lallemant M, Lynen L, Marconi VC, Margot NA, Moussa S, Ndung'u T, Nyambi PN, Orrell C, Schapiro JM, Schuurman R, Sirivichayakul S, Smith D, Zolfo M, Jordan MR, Shafer RW. Nucleoside reverse transcriptase inhibitor resistance mutations associated with first-line stavudine-containing antiretroviral therapy: programmatic implications for countries phasing out stavudine. J Infect Dis. 2013 Jun 15;207 Suppl 2:S70-7. doi: 10.1093/infdis/jit114.

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: May 25, 2015
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 June 01, 2015