A Phase 2 interventional study of dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen and Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF) in HIV Infection, sponsored by PENTA Foundation. Completed at 3 sites in 2 countries. Open to participants aged 28 Days to 10 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by PENTA Foundation · Phase 2, Interventional, and Treatment
This study aims to find out whether treating children living with HIV with three anti-HIV medicines, dolutegravir (DTG), emtricitabine (FTC) and tenofovir alafenamide (TAF), with a novel dose ratio will achieve adequate drug concentrations and is safe. The optimal DTG/FTC/TAF dose ratio will be used for the development of a fixed-dose combination dispersible tablet.
Dolutegravir (DTG), Emtricitabine (FTC) and Tenofovir alafenamide (TAF) are anti-HIV medicines. DTG works very well, can be taken once-daily and has few side effects. In international treatment guidelines, DTG is one of the most recommended medicines for adults and young people. Emtricitabine is also one of the preferred medicines in anti-HIV treatment for adults and children. Tenofovir alafenamide (TAF) is not yet recommended in children \<25 kg, however TAF could potentially be used safely and effectively in children.
Combining DTG, FTC and TAF in a specific dose ratio may offer treatment that is safe and effective. If so, a combination dispersible tablet containing these three medicines can be developed and this will allow the same HIV medicines to be used across children and adults.
This study will include 50 children aged 28 days to less than 10 years old who are living with HIV. All participants will receive the same treatment with DTG, FTC and TAF. Subjects will receive DTG 10 mg dispersible tablets and FTC/TAF 15/1.88 mg dispersible tablets or DTG 50 mg film coated tablets and FTC/TAF 200/25 mg film coated tablets depending on weight band. All children in the study will have clinical assessments. Blood tests will be performed to make sure that the medicines are safe and, at some visits, participants and carers will also be asked to answer some questions on taking medicine and how medicine tastes. All children will be followed up for 24 weeks.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 53 is below the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →PENTA Foundation is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Switch or start dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen with a novel dose ratio for HIV treatment. Subjects will receive DTG 10 mg dispersible tablets and FTC/TAF 15/1.88 mg dispersible tablets or DTG 50 mg film coated tablets and FTC/TAF 200/25 mg film coated tablets depending on weight band
Drug: dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen · Drug: Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)
Switch or start dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen with a novel dose ratio for HIV treatment
Drug pages: Dolutegravir · Emtricitabine · Tenofovir alafenamide
Single arm
Primary endpoints for DTG:
\- Geometric mean Ctrough concentration
Time frame: From enrollment to the end of treatment at 24 weeks
Primary endpoints for DTG:
Percentage of individual Ctrough concentrations below the 90% effective concentration (EC90) (0.32 mg/L)
Time frame: From enrollment to the end of treatment at 24 weeks
Primary endpoints for DTG:
\- Geometric mean DTG Ctrough, Cmax, and AUC
Time frame: From enrollment to the end of treatment at 24 weeks
Primary safety endpoints
\- Occurrence of serious adverse events
Time frame: From enrollment to the end of treatment at 24 weeks
Primary safety endpoints
\- Occurrence of new clinical and laboratory grade 3 and 4 adverse events
Time frame: From enrollment to the end of treatment at 24 weeks
Primary safety endpoints
Occurrence of adverse events (of any grade) leading to treatment modification
Time frame: From enrollment to the end of treatment at 24 weeks
Primary endpoints for FTC/TAF:
\- Geometric mean Ctrough, Cmax, and AUC
Time frame: From enrollment to the end of treatment at 24 weeks
Primary endpoints for FTC/TAF:
Intracellular tenofovir diphosphate (TDP) levels at 24 hours acquired through dried blood spot analysis
Time frame: From enrollment to the end of treatment at 24 weeks
Efficacy endpoints
\- Viral load (VL) \<400 c/ml at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
Efficacy endpoints
Occurrence of new or recurrent WHO clinical stage 3 or 4 event
Time frame: From enrollment to the end of treatment at 24 weeks
Plan to share: No — IPD will be supporting a generic company dossier subject to FDA evaluation
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Jun 2025, 6 months.
Of 65 non-industry phase 2 interventional studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 74. This study's 6 months is below that.
Counting every sponsor, half of 99 studies reached it within 31 months; a quarter within 17 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dolutegravir · Emtricitabine · Tenofovir alafenamide
PENTA Foundation