HIV InfectionsNCT00476606
A Prospective Cohort of Children With HIV Infection
An observational study of HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
Trial summary
To evaluate clinical and immunological outcome of children treated with HAART. Read more about this study
- Who is it for?
- Ages 1 day to 20 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zidovudine, Stavudine, Didanosine, Lamivudine, Nevirapine, Efavirenz and LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir
- How many people
- 500 participants
- Where
- 3 sitesThailand
- Study dates
- Mar 2003to 12 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: HIV-infected infants, children and adolescents (range age 1 day - 20 years old) who have participated in HIV-NAT trials
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
HIV-NAT
Bangkok, 10330
Pediatric infectious diseases section, Chulalongkorn University
Bangkok, 10330
Khon Kaen University
Khon Kaen, 40002
About this study
Official title: Treatment Outcome of Children With HIV Infection
To evaluate clinical and immunological outcome of children treated with HAART.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Zidovudine, Stavudine, Didanosine, Lamivudine, Nevirapine, Efavirenz, LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir
- Keywords
- HIV children, HAART, ARV, Second line HAART, Viral Load, Combination drug, Treatment Experienced, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zidovudine, Stavudine, Didanosine, LamivudineDrug
Refer to the Thai guideline for HIV management 2007
Nevirapine, EfavirenzDrug
Refer to the Thai guideline for HIV management 2007
LPV/r, Saquinavir, Indinavir, Ritonavir, NelfinavirDrug
Refer to the Thai guideline for HIV management 2007
| Study group | Role | What they receive |
|---|---|---|
| Long-term pediatric cohort | Long-term follow-up cohort since 2003 Receives: Drug: Zidovudine, Stavudine, Didanosine, Lamivudine; Drug: Nevirapine, Efavirenz; Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMar 2003
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Khon Kaen University
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, MSc, Principal investigator, HIV-NAT, The Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476606
- Sponsor's protocol ID
- HIV-NAT 015
- Status last verified
- Mar 2025
- First submitted
- 20 May 2007
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
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.
PubMed 22026962Sirikum 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.
PubMed 24625136
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome of Children With HIV Infection
- ClinicalTrials.gov ID
- NCT00476606
- Acronym / sponsor ID
- HIV-NAT 015
- Conditions
- HIV Infections
- Keywords
- HIV children, HAART, ARV, Second line HAART, Viral Load, Combination drug, Treatment Experienced, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Khon Kaen University
- Study start
- Mar 2003 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term pediatric cohort | – | Drug: Zidovudine, Stavudine, Didanosine, Lamivudine, Drug: Nevirapine, Efavirenz, Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, NelfinavirLong-term follow-up cohort since 2003 |
Who may qualify
- Ages
- 1 day to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HIV-infected infants, children and adolescents (range age 1 day - 20 years old) who have participated in HIV-NAT trials
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine, Stavudine, Didanosine, LamivudineRefer to the Thai guideline for HIV management 2007 | Drug | Long-term pediatric cohort |
| Nevirapine, EfavirenzRefer to the Thai guideline for HIV management 2007 | Drug | Long-term pediatric cohort |
| LPV/r, Saquinavir, Indinavir, Ritonavir, NelfinavirRefer to the Thai guideline for HIV management 2007 | Drug | Long-term pediatric cohort |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Results publicationBunupuradah 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
- Results publication: PubMed 22026962Bunupuradah 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.
- Results publication: PubMed 24625136Sirikum 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.
- Click here for more information about HIV-NAT 015Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiat Ruxrungtham, MD, MSc principal investigator
HIV-NAT, The Thai Red Cross AIDS Research Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00476606, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.