A Prospective Cohort of Children With HIV Infection

NCT00476606 | Completed DMC

• 1 other identifier: HIV-NAT 015
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

HIV Infections

Keywords

HIV children; HAART; ARV; Second line HAART; Viral Load; Combination drug; Treatment Experienced; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• 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

  every 3 months

Study Arms (1)

Long-term pediatric cohort

Long-term follow-up cohort since 2003

Drug: Zidovudine, Stavudine, Didanosine, Lamivudine; Drug: Nevirapine, Efavirenz; Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir

Interventions

Zidovudine, Stavudine, Didanosine, Lamivudine DRUG

Refer to the Thai guideline for HIV management 2007

Long-term pediatric cohort

Nevirapine, Efavirenz DRUG

Refer to the Thai guideline for HIV management 2007

Long-term pediatric cohort

LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir DRUG

Refer to the Thai guideline for HIV management 2007

Long-term pediatric cohort

Eligibility Criteria

• Age: 1 Day - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Khon Kaen University: collaborator

Study Sites (3)

HIV-NAT

Bangkok, 10330, Thailand

Location

Pediatric infectious diseases section, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (3)

• 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

  RESULT

• 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.

  PMID: 22026962 RESULT

• 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.

  PMID: 24625136 RESULT

Related Links

• Click here for more information about HIV-NAT 015

Biospecimen

Retention: SAMPLES WITH DNA

PBMC

MeSH Terms

Conditions

HIV Infections

Interventions

Zidovudine; Stavudine; Didanosine; Lamivudine; Nevirapine; efavirenz; Saquinavir; Indinavir; Ritonavir; Nelfinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides; Zalcitabine; Deoxycytidine; Cytidine; Pyridines; Isoquinolines; Quinolines; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Kiat Ruxrungtham, MD, MSc

  HIV-NAT, The Thai Red Cross AIDS Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2007
• First Posted: May 22, 2007
• Study Start: March 1, 2003
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

TH (3)