A Prospective Cohort of Children With HIV Infection

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2016 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: February 19, 2016

Last verified: February 2016

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Stavudine Zidovudine Didanosine Saquinavir Nevirapine Lamivudine Indinavir Efavirenz Ritonavir Nelfinavir

U.S. FDA Resources

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 (Child, Adult)
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:

Click here for more information about HIV-NAT 015 This link exits the ClinicalTrials.gov site

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

Bunupuradah T, Puthanakit T, Kosalaraksa P, Kerr S, Boonrak P, Prasitsuebsai W, Lumbiganon P, Mengthaisong T, Phasomsap C, Pancharoen C, Ruxrungtham K, Ananworanich J. Immunologic and virologic failure after first-line NNRTI-based antiretroviral therapy in Thai HIV-infected children. AIDS Res Ther. 2011 Oct 26;8:40. doi: 10.1186/1742-6405-8-40.

Sirikum C, Sophonphan J, Chuanjaroen T, Lakonphon S, Srimuan A, Chusut P, Do TC, Prasitsuebsai W, Puthanakit T, Ananworanich J, Bunupuradah T; HIV-NAT 015 study team. HIV disclosure and its effect on treatment outcomes in perinatal HIV-infected Thai children. AIDS Care. 2014;26(9):1144-9. doi: 10.1080/09540121.2014.894614. Epub 2014 Mar 13.


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:	February 19, 2016
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:


Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Stavudine	Didanosine Efavirenz Nevirapine Lamivudine Ritonavir Indinavir Saquinavir Nelfinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents

ClinicalTrials.gov processed this record on September 30, 2016

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