Study 10 of 466 for search of: Thailand
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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.
Verified by Institut de Recherche pour le Developpement, April 2008
Sponsors and Collaborators: Institut de Recherche pour le Developpement
Global Fund
Ministry of Health, Thailand
Information provided by: Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT00433030
  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

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective

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 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433030

Contacts
Contact: Marc Lallemant, MD +66 53814633 ext 0 marc@phpt.org
Contact: Gonzague Jourdain, MD, PhD +66 53814633 ext 0 gonzague@phpt.org

  Show 38 Study Locations
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

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: PHPT-Cohort
Study First Received: February 8, 2007
Last Updated: April 30, 2008
ClinicalTrials.gov Identifier: NCT00433030  
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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009