HIVNCT02404259
PK TDF in Thai HIV-infected Children
A study testing TDF (Tenofovir), Efavirenz and lopinavir/ritonavir, atazanavir/ritonavir in people with HIV, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
This study will assess the pharmacokinetics of TDF in Thai HIV-infected children Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- HIV
- What is being tested?
- TDF (Tenofovir), Efavirenz and lopinavir/ritonavir, atazanavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to May 2012
- Phase
- Interventional
- 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
Who may be able to join
- children between the ages of 8-18 years with documented HIV infection
- currently on TDF once daily regimen
- have signed the informed consent
Who cannot join
- the child or care taker refuse to participate in the study
- severity of adverse events is more than grade 3 thirty days before participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics Study of Tenofovir in HIV-infected Thai Children Using Tenofovir-based Regimen
This study will assess the pharmacokinetics of TDF in Thai HIV-infected children
Read the detailed description
HIV-infected children who are currently on TDF-base once daily regimen will be enrolled into this study. PK visit will be performed at least 1 month after changing regimen to once daily regimen. Adherence 3 days before PK study will be confirmed using adherence questionnaire. 100% of adherence is needed for PK study. If there is adherence problem on PK visit, PK study will be deferred to at least 3 days. On PK visit, blood drawn will be performed at 0, 2, 4, 6, 8, 10, 12, 24 hr. after taking ARVs for PK study. Blood drawn for safety evaluation will be drawn at any time-point on the PK visit. There is no study drug in this study. All ARVs that patient taking will be according to patient's requirement, and physician judgment. ARVs dosage will follow the Thai national pediatric guideline. CBC, CD4, viral RNA, viral resistance, ALT, cholesterol, and triglyceride results can be from other visits within 4 weeks window period.
Statistical considerations Sample size calculations. There are no pharmacokinetic data in children. In adults, the mean (SD) AUC following administration of a 300mg Viread tablet in fasting state is 2.29 (0.69) microg.hr/mL. In patients taking lopinavir/ritonavir and atazanavir/ritonavir, the mean AUC of TDF is increased by 32% and 24% respectively. Efavirenz does not change the AUC of TDF. If the weight adjusted dose of TDF in children and adolescents achieves the same AUC as in adults and concomitant dosing with a protease inhibitor increases the TDF AUC by 30% but concomitant dosing with Efavirenz does not change the TDF AUC, then 20 treated with Efavirenz and 20 patients treated on a PI based regimen would provide 90% power to detect this difference at the 5% significance level.
Statistical Analysis.
Primary endpoints Pharmacokinetic parameters will be calculated based on individual plasma concentration vs time data, using noncompartmental methods. Data will be summarized overall and by whether the patient is taking a PI or an EFV-based regimen. Formal statistical comparisons of parameters will be made using ANOVA techniques or non-parametric equivalents as appropriate. Effect sizes and 95% confidence intervals will be given for all comparisons.
- Conditions
- HIV
- Being tested
- TDF (Tenofovir), Efavirenz, lopinavir/ritonavir, atazanavir/ritonavir
- Keywords
- pharmacokinetics, TDF, HIV-infected children, Thai, non-nucleoside reverse transcriptase inhibitor (NNRTI), ritonavir-boosted protease inhibitor (bPI), less than eighteen years old
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDF (Tenofovir)Drug
EfavirenzDrug
lopinavir/ritonavir, atazanavir/ritonavirDrug
| Study group | Role | What they receive |
|---|---|---|
| non-nucleoside reverse transcriptase inhibitor (NNRTI) | Other | Efavirenz Receives: Drug: TDF (Tenofovir); Drug: Efavirenz |
| ritonavir-boosted protease inhibitor | Other | lopinavir/ritonavir atazanavir/ritonavir Receives: Drug: TDF (Tenofovir); Drug: lopinavir/ritonavir, atazanavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve (AUC) (pharmacokinetics of TDF)
pharmacokinetics of TDF in children between the ages of 8-18 years
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Khon Kaen University
- Responsible party
- Sponsor
- Investigators
- Thanyawee Puthanakit, MD, Principal investigator, HIV-NAT and Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404259
- Sponsor's protocol ID
- HIV-NAT 131
- Status last verified
- Mar 2015
- First submitted
- 7 Feb 2013
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Tenofovir in HIV-infected Thai Children Using Tenofovir-based Regimen
- ClinicalTrials.gov ID
- NCT02404259
- Acronym / sponsor ID
- HIV-NAT 131
- Conditions
- HIV
- Keywords
- pharmacokinetics, TDF, HIV-infected children, Thai, non-nucleoside reverse transcriptase inhibitor (NNRTI), ritonavir-boosted protease inhibitor (bPI), less than eighteen years old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Khon Kaen University
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Mar 2015 (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 pharmacokinetics of TDF in Thai HIV-infected children
Detailed description
HIV-infected children who are currently on TDF-base once daily regimen will be enrolled into this study. PK visit will be performed at least 1 month after changing regimen to once daily regimen. Adherence 3 days before PK study will be confirmed using adherence questionnaire. 100% of adherence is needed for PK study. If there is adherence problem on PK visit, PK study will be deferred to at least 3 days. On PK visit, blood drawn will be performed at 0, 2, 4, 6, 8, 10, 12, 24 hr. after taking ARVs for PK study. Blood drawn for safety evaluation will be drawn at any time-point on the PK visit. There is no study drug in this study. All ARVs that patient taking will be according to patient's requirement, and physician judgment. ARVs dosage will follow the Thai national pediatric guideline. CBC, CD4, viral RNA, viral resistance, ALT, cholesterol, and triglyceride results can be from other visits within 4 weeks window period.
Statistical considerations Sample size calculations. There are no pharmacokinetic data in children. In adults, the mean (SD) AUC following administration of a 300mg Viread tablet in fasting state is 2.29 (0.69) microg.hr/mL. In patients taking lopinavir/ritonavir and atazanavir/ritonavir, the mean AUC of TDF is increased by 32% and 24% respectively. Efavirenz does not change the AUC of TDF. If the weight adjusted dose of TDF in children and adolescents achieves the same AUC as in adults and concomitant dosing with a protease inhibitor increases the TDF AUC by 30% but concomitant dosing with Efavirenz does not change the TDF AUC, then 20 treated with Efavirenz and 20 patients treated on a PI based regimen would provide 90% power to detect this difference at the 5% significance level.
Statistical Analysis.
Primary endpoints Pharmacokinetic parameters will be calculated based on individual plasma concentration vs time data, using noncompartmental methods. Data will be summarized overall and by whether the patient is taking a PI or an EFV-based regimen. Formal statistical comparisons of parameters will be made using ANOVA techniques or non-parametric equivalents as appropriate. Effect sizes and 95% confidence intervals will be given for all comparisons.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-nucleoside reverse transcriptase inhibitor (NNRTI) | Other | Drug: TDF (Tenofovir), Drug: EfavirenzEfavirenz |
| ritonavir-boosted protease inhibitor | Other | Drug: TDF (Tenofovir), Drug: lopinavir/ritonavir, atazanavir/ritonavirlopinavir/ritonavir atazanavir/ritonavir |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children between the ages of 8-18 years with documented HIV infection
- currently on TDF once daily regimen
- have signed the informed consent
Key exclusion criteria (2 listed)
- the child or care taker refuse to participate in the study
- severity of adverse events is more than grade 3 thirty days before participating in the 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 |
|---|---|---|
| TDF (Tenofovir) | Drug | non-nucleoside reverse transcriptase inhibitor (NNRTI), ritonavir-boosted protease inhibitor |
| Efavirenz | Drug | non-nucleoside reverse transcriptase inhibitor (NNRTI) |
| lopinavir/ritonavir, atazanavir/ritonavir | Drug | ritonavir-boosted protease inhibitor |
Primary outcome
area under the curve (AUC) (pharmacokinetics of TDF)
Time frame: 12 months
pharmacokinetics of TDF in children between the ages of 8-18 years
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 31 Mar 2015.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s websiteLink 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.
Thanyawee Puthanakit, MD principal investigator
HIV-NAT and Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDF (Tenofovir), Efavirenz and lopinavir/ritonavir, atazanavir/ritonavir in people with HIV, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site 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 3 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
area under the curve (AUC) (pharmacokinetics of TDF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2015.