A Prospective Cohort of Children With HIV Infection

HIV Infections Clinical Trial

Official title:

Treatment Outcome of Children With HIV Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00476606
• Other study ID #: HIV-NAT 015
• Status: Active, not recruiting
• Start date: March 2003
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infections

Intervention

Drug:
• Zidovudine, Stavudine, Didanosine, Lamivudine
Refer to the Thai guideline for HIV management 2007
• Nevirapine, Efavirenz
Refer to the Thai guideline for HIV management 2007
• LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir
Refer to the Thai guideline for HIV management 2007

Locations

Country	Name	City	State
Thailand	HIV-NAT	Bangkok
Thailand	Pediatric infectious diseases section, Chulalongkorn University	Bangkok
Thailand	Khon Kaen University	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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 i — View 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 nucleo

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 child — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Click here for more information about HIV-NAT 015