Pediatric HIV InfectionPhase 2NCT05006170
Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV
A Phase 2 study testing DTG DT 20 mg and DTG DT 25 mg in people with Pediatric HIV Infection, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection weighing from 6 to below 20 kg and to determine the dose of DTG that achieves adult target PK parameter(trough concentration; AUC24h) Read more about this study
- Who is it for?
- Ages 3 months to 7 years
- Conditions the study is for
- Pediatric HIV Infection
- What is being tested?
- DTG DT 20 mg and DTG DT 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 3 Aug 2021to 30 Jun 2022
- Phase
- Phase 2
- 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 3 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children living with HIV weighing 6 to below 20 kg
- Naïve to integrase inhibitors
Who cannot join
- Currently active opportunistic infection
- Liver dysfunction (SGPT below 100 IU/mL)
- Renal dysfunction (GFR below 60 mL/min)
- Currently using medication that interacts with DTG
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Athiporn Premgamone, MD, +6622564000 ext. 4930, athiporn.p@chula.ac.th
Thanyawee Puthanakit, MD, +6622564000 ext. 4930, thanyawee.p@chula.ac.th
About this study
The purpose of this study is to evaluate steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection weighing from 6 to below 20 kg and to determine the dose of DTG that achieves adult target PK parameter(trough concentration; AUC24h)
Read the detailed description
After being informed about the study and potential risks, all legal guardians giving written informed consent will undergo check eligibility to enroll the study entry. Patients will be sort into 3 weight band groups 6 to below 10 kg, 10 to below 14 kg, and 14 to below 20 kg. ARTs will be switched to DTG dispersible tablet and ABC/3TC once daily will be prescribed according to weight band dosage. Total of 7 time point of blood sampling for plasma DTG concentrations will be measure at 7-14 day after medication switch. Patient will be follow up as schedule for total 24 week to assess safety, and efficacy of DTG dispersible tablet combine with ABC/3TC.
- Conditions
- Pediatric HIV Infection
- Being tested
- DTG DT 20 mg, DTG DT 25 mg
- Keywords
- dolutegravir dispersible tablet, pharmacokinetics, weight below 20 kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTG DT 20 mgDrug
Also called MYLTEGA Dispersible Tablet
Give 2 tabs of MYLTEGA DT (10mg) PO once daily
DTG DT 25 mgDrug
Also called MYLTEGA DT Dispersible Tablet
Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily
| Study group | Role | What they receive |
|---|---|---|
| 6 to below 10 kg weight band | Experimental | Children with perinatal HIV infection whose weight from 6 kg to below 10 kg Receives: Drug: DTG DT 20 mg |
| 10 to below 14 kg weight band | Experimental | Children with perinatal HIV infection whose weight from 10 kg to below 14 kg Receives: Drug: DTG DT 20 mg |
| 14 to below 20 kg weight band | Experimental | Children with perinatal HIV infection whose weight from 14 kg to below 20 kg Receives: Drug: DTG DT 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection
Trough plasma DTG concentration and DTG exposure (AUC24h)
Measured: At 7-14 day after started on DTG
Secondary outcomes (2)
Serious adverse event incidence
Incidence of grade 3 and 4 adverse events in use of DTG for HIV treatment in
Measured: 24 week after medication switched
Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies
HIV VL <40 copies/mL
Measured: 24 week after medication switched
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start3 Aug 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric HIV InfectionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Each participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tablet
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athiporn Premgamone, MD, Principal investigator, Chulalongkorn UniversityThanyawee Puthanakit, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006170
- Sponsor's protocol ID
- DTGkids
- Status last verified
- Jul 2021
- First submitted
- 4 Aug 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV
- ClinicalTrials.gov ID
- NCT05006170
- Acronym / sponsor ID
- DTGkids
- Conditions
- Pediatric HIV Infection
- Keywords
- dolutegravir dispersible tablet, pharmacokinetics, weight below 20 kg
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 16 Aug 2021 (actual)
- 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.
The purpose of this study is to evaluate steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection weighing from 6 to below 20 kg and to determine the dose of DTG that achieves adult target PK parameter(trough concentration; AUC24h)
Detailed description
After being informed about the study and potential risks, all legal guardians giving written informed consent will undergo check eligibility to enroll the study entry. Patients will be sort into 3 weight band groups 6 to below 10 kg, 10 to below 14 kg, and 14 to below 20 kg. ARTs will be switched to DTG dispersible tablet and ABC/3TC once daily will be prescribed according to weight band dosage. Total of 7 time point of blood sampling for plasma DTG concentrations will be measure at 7-14 day after medication switch. Patient will be follow up as schedule for total 24 week to assess safety, and efficacy of DTG dispersible tablet combine with ABC/3TC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tablet
| Arm | Type | Receives |
|---|---|---|
| 6 to below 10 kg weight band | Experimental | Drug: DTG DT 20 mgChildren with perinatal HIV infection whose weight from 6 kg to below 10 kg |
| 10 to below 14 kg weight band | Experimental | Drug: DTG DT 20 mgChildren with perinatal HIV infection whose weight from 10 kg to below 14 kg |
| 14 to below 20 kg weight band | Experimental | Drug: DTG DT 25 mgChildren with perinatal HIV infection whose weight from 14 kg to below 20 kg |
Who may qualify
- Ages
- 3 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children living with HIV weighing 6 to below 20 kg
- Naïve to integrase inhibitors
Key exclusion criteria (4 listed)
- Currently active opportunistic infection
- Liver dysfunction (SGPT below 100 IU/mL)
- Renal dysfunction (GFR below 60 mL/min)
- Currently using medication that interacts with DTG
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 |
|---|---|---|
| DTG DT 20 mgAlso: MYLTEGA Dispersible TabletGive 2 tabs of MYLTEGA DT (10mg) PO once daily | Drug | 10 to below 14 kg weight band, 6 to below 10 kg weight band |
| DTG DT 25 mgAlso: MYLTEGA DT Dispersible TabletGive 2.5 tabs of MYLTEGA DT (10mg) PO once daily | Drug | 14 to below 20 kg weight band |
Primary outcome
Steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection
Time frame: At 7-14 day after started on DTG
Trough plasma DTG concentration and DTG exposure (AUC24h)
2 secondary outcomes
Serious adverse event incidence
Time frame: 24 week after medication switched
Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies
Time frame: 24 week after medication switched
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Athiporn Premgamone, MD principal investigator
Chulalongkorn University
Thanyawee Puthanakit, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DTG DT 20 mg and DTG DT 25 mg in people with Pediatric HIV Infection, run by Chulalongkorn University 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athiporn Premgamone, MD (+6622564000 ext. 4930, athiporn.p@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection (time frame: At 7-14 day after started on DTG). 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 23 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.