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A Prospective Cohort of Children With HIV Infection

This study is currently recruiting participants.
Verified April 2012 by The HIV Netherlands Australia Thailand Research Collaboration
Sponsor:
Collaborator:
Khon Kaen University
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476606
First received: May 20, 2007
Last updated: April 3, 2012
Last verified: April 2012
History of Changes

May 20, 2007
April 3, 2012
March 2003
December 2013   (final data collection date for primary outcome measure)
1. To collect clinical and immunologic data of children treated with HAART 2. To collect clinical outcome data on children with HIV infection 3. To provide the best possible care to children with HIV infection [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
1. To collect clinical and immunologic data of children treated with HAART 2. To collect clinical outcome data on children with HIV infection 3. To provide the best possible care to children with HIV infection [ Time Frame: every 3 months ]
Complete list of historical versions of study NCT00476606 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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A Prospective Cohort of Children With HIV Infection
Treatment Outcome of Children With HIV Infection

To evaluate clinical and immunological outcome of children treated with HAART.

This is a long term cohort study that was started in 2002. Currently, there are 120 children enrolled in the study and are receiving HIV care according to standard practice set by the Thai Ministry of Public Health. HIV-infected parents also receive care at the same clinic.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Zidovudine, Stavudine, Didanosine, Lamivudine
    Refer to the Thai guideline for HIV management 2007
  • Drug: Nevirapine, Efavirenz
    Refer to the Thai guideline for HIV management 2007
  • Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir
    Refer to the Thai guideline for HIV management 2007
Not Provided
Bunupuradah T., Puthanakit T., Boonrak P., Butterworth O., Mengthaisong T., Intasan J., Ubolyam S., Kosalaraksa P., Engchanil C., Pancharoen C., Lumbiganond P., Phanuphak P., Ananworanich J., HIV-NAT Pediatric Study Team. Efficacy and safety of non nucleoside reverse transcriptase inhibitor (NNRTI) based highly active antiretroviral therapy (HAART) in Thai children with HIV, poster No. TUPEB128. Poster presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Sydney, Australia, July 22-25, 2007

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children who are part of the ATC program at Chulalongkorn hospital and at HIV-NAT, The Thai Red Cross AIDS research center
  • Children who fulfil criteria to start HAART according to the ATC program
  • Children who are switched to second regimen or salvage therapy
  • Children who are on any antiretroviral regimens, including post trial children from other HIV-NAT study (both at HIV-NAT and Khon Kaen University sites)
  • Children with HIV infection who are not on antiretroviral therapy
  • Caretakers understand the purpose of data and plasma samples collection, and have signed the consent form

Exclusion Criteria:

  • Patients and caretakers may choose to stop HAART at anytime during the study. If they agree, we would continue to follow them in this study.
Both
up to 20 Years
No
Contact: Torsak Bunupuradah, MD 662-652-3040 Torsak.B@HIVNAT.org
Thailand
 
NCT00476606
HIV-NAT 015
Yes
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
Khon Kaen University
Principal Investigator: Kiat Ruxrungtham, MD, MSc HIV-NAT, The Thai Red Cross AIDS Research Centre
The HIV Netherlands Australia Thailand Research Collaboration
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP