Clinical trial NCT00476606: A Prospective Cohort of Children With HIV Infection
Official title: Treatment Outcome of Children With HIV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV children
HAART
ARV
Second line HAART
Viral Load
Combination drug
Treatment Experienced
Treatment Naive
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
First posted: 2007-05-22
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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 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.

Primary outcomes:
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
timeFrame: every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT
city: Bangkok
country: Thailand
facility: Pediatric infectious diseases section, Chulalongkorn University
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
affiliation: HIV-NAT, The Thai Red Cross AIDS Research Centre
name: Kiat Ruxrungtham, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.