A Prospective Cohort of Children With HIV Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 19, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Zidovudine, Stavudine, Didanosine, Lamivudine
Drug: Nevirapine, Efavirenz
Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Outcome of Children With HIV Infection

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

PBMC


Estimated Enrollment: 1000
Study Start Date: March 2003
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Long-term pediatric cohort
Long-term follow-up cohort since 2003
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected infants, children and adolescents (range age 1 day - 20 years old) who have participated in HIV-NAT trials

Criteria

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.
  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: NCT00476606

Contacts
Contact: Torsak Bunupuradah, MD 662-652-3040 Torsak.B@HIVNAT.org

Locations
Thailand
HIV-NAT Recruiting
Bangkok, Thailand, 10330
Contact: Torsak Bunupuradah, MD    662-652-3040    Torsak.B@HIVNAT.org   
Sub-Investigator: Torsak Bunupuradah, MD         
Sub-Investigator: Jintanat Ananworanich, MD         
Sub-Investigator: Thanyawee Puthanakit, MD         
Pediatric infectious diseases section, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Chitsanu Pancharoen, MD         
Khon Kaen University Recruiting
Khon Kaen, Thailand, 40002
Contact: Pope Kosalaraksa, MD         
Sub-Investigator: Chulapan Engchanil, MD         
Sub-Investigator: Pagakrong Lumbiganon, MD         
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Khon Kaen University
Investigators
Principal Investigator: Kiat Ruxrungtham, MD, MSc HIV-NAT, The Thai Red Cross AIDS Research Centre
  More Information

Additional Information:
Publications:
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

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT00476606     History of Changes
Other Study ID Numbers: HIV-NAT 015
Study First Received: May 20, 2007
Last Updated: August 19, 2014
Health Authority: Thailand: Ministry of Public Health

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
HIV children
HAART
ARV
Second line HAART
Viral Load
Combination drug
Treatment Experienced
Treatment Naive

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

ClinicalTrials.gov processed this record on October 20, 2014