HIV-infected Thai ChildrenNCT01815255
TDF Long Term Study
An observational study of HIV-infected Thai Children, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.
Trial summary
This study will assess the safety and efficacy of generic TDF from Governmental Pharmaceutical Organization (GPO) in HIV-infected children Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- HIV-infected Thai Children
- What is being tested?
- tenofovir (TDF)
- How many people
- 36 participants
- Where
- 2 sitesThailand
- Study dates
- Dec 2010to Aug 2013
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: HIV-infected children who are currently taking or are changing to tenofovir-(TDF) based regimen
Who may be able to join
- children who are changing to TDF due to adherence problem or treatment failure
- children who are already on TDF due to their clinical indication
Who cannot join
- child/caretaker refuse to participate in this study
- cannot adhere to the study schedule
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
HIV-NAT
Bangkok, 10330
King Chulalongkorn Hospital, Chulalongkorn University
Bangkok, 10330
About this study
Official title: Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children
This study will assess the safety and efficacy of generic TDF from Governmental Pharmaceutical Organization (GPO) in HIV-infected children
Read the detailed description
TDF is a nucleotide reverse transcriptase inhibitor (NRTI) which can be taken only once per day and continues to have good efficacy even in patients who have resistance to other NNRTI in the absence of K65R mutation. TDF is a choice for patients with NRTI resistance, or those that require once-daily regimen to improve adherence. Currently, TDF has not been approved by the US FDA for children less than 18 years, but pediatricians has been using TDF in children who have treatment failure because of limitation of a more appropriate pediatric ARV. The Thai national guideline for pediatric 2009 recommend the use of TDF in children who have failed the first line therapy with multi-NRTI mutation and are more than 30 kilograms or have tanner stage 4 or more. However, the problem is that there is no pediatric TDF formulation. The available preparation of 300 mg tear drop tablet, if cut in half, may increase dosing errors, more or less by 18-37%. This will affect the blood level and/or toxicities. Therefore, the Thai Governmental Pharmaceutical Organization (GPO) has produced a generic TDF formulation that can be used in HIV-infected children. This study will assess the safety and efficacy information in children using this generic pediatric TDF formulation.
- Conditions
- HIV-infected Thai Children
- Being tested
- tenofovir (TDF)
- Keywords
- TDF-based regimen, HIV-infected children, Thai, generic, safety and efficacy, renal status, To assess effect of TDF on renal problem in HIV-infected children receiving TDF-based once daily regimen, To compare the effectiveness and clinical usefulness of different tools of adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir (TDF)Drug
| Study group | Role | What they receive |
|---|---|---|
| tenofovir (TDF) | HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication Receives: Drug: tenofovir (TDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
viral load
Number of patients who have viral load less than 50 copies/ml at week 48 and week 96
Measured: week 48 and 96
Secondary outcomes (4)
renal status
Number of patients with renal toxicity assessed by GFR and with proximal tubular effect
Measured: weeks 24, 48, 72, and 96
adherence
Agreement between self reported adherence by visual analogue scale (VAS) pill count and TDM Sensitivity and specificity of self-reported adherence and pill count against gold standards of TDM and undetectable viral load
Measured: every 3 months
resistance
Resistant mutations in patients who fail TDF-based regimen and response to new regimen
Measured: every 3 months
adverse events
Proportion of patients who develop adverse events which are related to TDF and other ARVs
Measured: weeks 24, 48, 72, and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startDec 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-infected Thai ChildrenStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Bamrasnaradura Infectious Diseases Institute
- Responsible party
- Sponsor
- Investigators
- Wasana Prasitsuebsai, MD, Principal investigator, The HIV Netherlands Australia Thailand Research CollaborationJurai Wongsawat, MD, Principal investigator, Bamrasnadura Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815255
- Sponsor's protocol ID
- HIV-NAT 133
- Status last verified
- Jul 2020
- First submitted
- 7 Feb 2013
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Prasitsuebsai W, Puthanakit T, Apornpong T, Keadpudsa S, Bunupuradah T, Chuanjaroen T, Thammajaruk N, Jupimai T, Kerr SJ, Ananworanich J. Bone and Renal Safety at 96 weeks of TDF-containing in HIV-infected Thai children. Abstract # 905 presented at the 21st CROI 2014, March 3-6, 2014 at Boston, USA
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children
- ClinicalTrials.gov ID
- NCT01815255
- Acronym / sponsor ID
- HIV-NAT 133
- Conditions
- HIV-infected Thai Children
- Keywords
- TDF-based regimen, HIV-infected children, Thai, generic, safety and efficacy, renal status, To assess effect of TDF on renal problem in HIV-infected children receiving TDF-based once daily regimen, To compare the effectiveness and clinical usefulness of different tools of adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Bamrasnaradura Infectious Diseases Institute
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Mar 2013 (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.
This study will assess the safety and efficacy of generic TDF from Governmental Pharmaceutical Organization (GPO) in HIV-infected children
Detailed description
TDF is a nucleotide reverse transcriptase inhibitor (NRTI) which can be taken only once per day and continues to have good efficacy even in patients who have resistance to other NNRTI in the absence of K65R mutation. TDF is a choice for patients with NRTI resistance, or those that require once-daily regimen to improve adherence. Currently, TDF has not been approved by the US FDA for children less than 18 years, but pediatricians has been using TDF in children who have treatment failure because of limitation of a more appropriate pediatric ARV. The Thai national guideline for pediatric 2009 recommend the use of TDF in children who have failed the first line therapy with multi-NRTI mutation and are more than 30 kilograms or have tanner stage 4 or more. However, the problem is that there is no pediatric TDF formulation. The available preparation of 300 mg tear drop tablet, if cut in half, may increase dosing errors, more or less by 18-37%. This will affect the blood level and/or toxicities. Therefore, the Thai Governmental Pharmaceutical Organization (GPO) has produced a generic TDF formulation that can be used in HIV-infected children. This study will assess the safety and efficacy information in children using this generic pediatric TDF formulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tenofovir (TDF) | – | Drug: tenofovir (TDF)HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HIV-infected children who are currently taking or are changing to tenofovir-(TDF) based regimen
Key inclusion criteria (2 listed)
- children who are changing to TDF due to adherence problem or treatment failure
- children who are already on TDF due to their clinical indication
Key exclusion criteria (2 listed)
- child/caretaker refuse to participate in this study
- cannot adhere to the study schedule
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 |
|---|---|---|
| tenofovir (TDF) | Drug | tenofovir (TDF) |
Primary outcome
viral load
Time frame: week 48 and 96
Number of patients who have viral load less than 50 copies/ml at week 48 and week 96
4 secondary outcomes
renal status
Time frame: weeks 24, 48, 72, and 96
adherence
Time frame: every 3 months
resistance
Time frame: every 3 months
adverse events
Time frame: weeks 24, 48, 72, and 96
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 Jul 2020.
- Results publicationPrasitsuebsai W, Puthanakit T, Apornpong T, Keadpudsa S, Bunupuradah T, Chuanjaroen T, Thammajaruk N, Jupimai T, Kerr SJ, Ananworanich J. Bone and Renal Safety at 96 weeks of TDF-containing in HIV-infected Thai children. Abstract # 905 presented at the 21st CROI 2014, March 3-6, 2014 at Boston, USA
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s websiteLink provided by the sponsor.
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.
Wasana Prasitsuebsai, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
Jurai Wongsawat, MD principal investigator
Bamrasnadura Institute
2 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-infected Thai Children, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 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 2 inclusion and 2 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 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
viral load (time frame: week 48 and 96). 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 NCT01815255, which also lists 1 linked publication.
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 Jul 2020.