A Prospective Cohort of Children With HIV Infection - Full Text View

A Prospective Cohort of Children With HIV Infection

This study is currently recruiting participants.
Verified by The HIV Netherlands Australia Thailand Research Collaboration, May 2008

Sponsors and Collaborators:	The HIV Netherlands Australia Thailand Research Collaboration Khon Kaen University
Information provided by:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT00476606

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 IV

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Zidovudine Lamivudine Indinavir Indinavir Sulfate Didanosine Stavudine Nelfinavir Nelfinavir Mesylate Efavirenz Ritonavir Nevirapine Saquinavir Saquinavir mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Treatment Outcome of Children With HIV Infection

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 ]

Estimated Enrollment:	200
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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

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

Publications of Results:

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:	HIV-NAT ( Kiat Ruxrungtham )
Study ID Numbers:	HIV-NAT 015
First Received:	May 20, 2007
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00476606
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

Study placed in the following topic categories:

Efavirenz

Sexually Transmitted Diseases, Viral

Stavudine

Indinavir

Saquinavir

Acquired Immunodeficiency Syndrome

Zidovudine

Lamivudine

Immunologic Deficiency Syndromes

Virus Diseases

Nevirapine

Didanosine

Ritonavir

HIV Infections

Sexually Transmitted Diseases

Nelfinavir

Retroviridae Infections

Additional relevant MeSH terms:

Communicable Diseases

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 10, 2008