A Prospective Cohort of Children With HIV Infection

March 14, 2025 updated by: The HIV Netherlands Australia Thailand Research Collaboration

Treatment Outcome of Children With HIV Infection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • HIV-NAT
      • Bangkok, Thailand, 10330
        • Pediatric infectious diseases section, Chulalongkorn University
      • Khon Kaen, Thailand, 40002
        • Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Long-term pediatric cohort
Long-term follow-up cohort since 2003
Drug: Zidovudine, Stavudine, Didanosine, Lamivudine
Refer to the Thai guideline for HIV management 2007
Drug: Nevirapine, Efavirenz
Refer to the Thai guideline for HIV management 2007
Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir
Refer to the Thai guideline for HIV management 2007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Khon Kaen University

Investigators

  • Principal Investigator: Kiat Ruxrungtham, MD, MSc, HIV-NAT, The Thai Red Cross AIDS Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2003

Primary Completion (Actual)

September 12, 2024

Study Completion (Actual)

September 12, 2024

Study Registration Dates

First Submitted

May 20, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimated)

May 22, 2007

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT 015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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