A Prospective Cohort of Children With HIV Infection

Completed

• Conditions: HIV Infections
• Interventions: Drug: Zidovudine, Stavudine, Didanosine, Lamivudine; Drug: Nevirapine, Efavirenz; Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir

• Registration Number: NCT00476606
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2007-05-20
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2024-09-12
• Study Completion: 2024-09-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Long-term pediatric cohort	Zidovudine, Stavudine, Didanosine, Lamivudine	Long-term follow-up cohort since 2003
Long-term pediatric cohort	Nevirapine, Efavirenz	Long-term follow-up cohort since 2003
Long-term pediatric cohort	LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir	Long-term follow-up cohort since 2003

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

HIV-NAT; 🇹🇭 Bangkok, Thailand

Pediatric infectious diseases section, Chulalongkorn University; 🇹🇭 Bangkok, Thailand

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand