HIV InfectionPhase 2UNIVERSAL1NCT05993767

UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children

A Phase 2 study testing dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen and Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF) in people with HIV Infection, run by PENTA Foundation at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 28 days to 10 years
Conditions the study is for: HIV Infection
What is being tested?: dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen and Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 3 sitesin 2 countries
Study dates: 11 Dec 2024to 20 Jan 2026
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 28 days to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age between 28 days and 10 years old
Weighing 3 to <25 kg
Confirmed HIV-1 infection (local, molecular methods)
A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study
Girls who have reached menarche must have a negative pregnancy test at screening
Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment
Subjects already on a DTG-based ART regimen should be virologically suppressed at screening

Who cannot join

Age between 28 days and 10 years old
Weighing 3 to <25 kg
Confirmed HIV-1 infection (local, molecular methods)
A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study
Girls who have reached menarche must have a negative pregnancy test at screening

Show all 15Show fewer

Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment
Subjects already on a DTG-based ART regimen should be virologically suppressed at screening
History or presence of known allergy to DTG, FTC or TAF
Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN AND bilirubin ≥2xULN
Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Current or anticipated need for TB therapy during the study
Use of rifampicin-based therapy within 4 weeks before start trial
Presence of comedication known to interact with trial medications
Known resistance to INSTI or NRTI

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Uganda2 sites

Baylor College of Medicine Children's Foundation
Kampala
Joint Research Centre
Kampala

Other trials in Uganda

Zimbabwe1 site

University of Zimbabwe Clinical Research Centre
Harare

Other trials in Zimbabwe

About this study

Official title: Pharmacokinetic Study of an Optimized Dose Ratio of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Fumarate: Expediting a UNIVERSAL First Line Regimen for All Children Living With HIV in Africa

Read the detailed description

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.

Conditions: HIV Infection
Being tested: dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen, Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimenDrug
Switch or start dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen with a novel dose ratio for HIV treatment
Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)Drug
Single arm

Study groups in NCT05993767
Study group	Role	What they receive
dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen	Experimental	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 Receives: Drug: dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen; Drug: Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary endpoints for DTG:
- Geometric mean Ctrough concentration
Measured: 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)
Measured: From enrollment to the end of treatment at 24 weeks
Primary endpoints for DTG:
- Geometric mean DTG Ctrough, Cmax, and AUC
Measured: From enrollment to the end of treatment at 24 weeks
Primary safety endpoints
- Occurrence of serious adverse events
Measured: 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
Measured: From enrollment to the end of treatment at 24 weeks
Primary safety endpoints
Occurrence of adverse events (of any grade) leading to treatment modification
Measured: From enrollment to the end of treatment at 24 weeks
Primary endpoints for FTC/TAF:
- Geometric mean Ctrough, Cmax, and AUC
Measured: 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
Measured: From enrollment to the end of treatment at 24 weeks

Secondary outcomes (2)

Efficacy endpoints
- Viral load (VL) <400 c/ml at 24 weeks
Measured: From enrollment to the end of treatment at 24 weeks
Efficacy endpoints
Occurrence of new or recurrent WHO clinical stage 3 or 4 event
Measured: From enrollment to the end of treatment at 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 202420 Jan 2026

First posted15 Aug 2023
Study start11 Dec 2024
Primary completion30 Jun 2025
Study completion20 Jan 2026

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 InfectionStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: An interventional, phase I/II, multicenter, single-arm study
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05993767
Sponsor's protocol ID: UNIVERSAL1
Other IDs: RIA2019PD-2882
Acronym: UNIVERSAL1
Status last verified: Mar 2026
First submitted: 1 Aug 2023
Last updated: 4 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will be supporting a generic company dossier subject to FDA evaluation

Publications

Kamphuis AEM, Salvadori N, Mujuru HA, Bwakura-Dangarembizi M, Kisitu GP, Matovu F, Kaudha E, Mulindwa A, Jacobs TG, Than-In-At K, Cressey TR, Nardone A, Lallemant M, Colbers A, Burger DM; UNIVERSAL1 trial team. Expediting a UNIVERSAL first-line regimen of a dolutegravir-emtricitabine-tenofovir alafenamide fixed-dose ratio for children living with HIV older than 4 weeks: a 24-week, open-label, single-arm, phase 1-2, pharmacokinetic, safety, and antiviral activity trial. Lancet HIV. 2026 Sep 7:S2352-3018(26)00168-2. doi: 10.1016/S2352-3018(26)00168-2. Online ahead of print.
PubMed 42705257

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Study of an Optimized Dose Ratio of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Fumarate: Expediting a UNIVERSAL First Line Regimen for All Children Living With HIV in Africa
ClinicalTrials.gov ID: NCT05993767
Acronym / sponsor ID: UNIVERSAL1 / UNIVERSAL1
Conditions: HIV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: PENTA FoundationResearch network
Collaborators: Radboud University Medical Center, Baylor College of Medicine, Clinton Health Access Initiative Inc., University of Zimbabwe, Chiang Mai University, Joint Clinical Research Center
Study start: 11 Dec 2024 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 20 Jan 2026 (actual)
First posted: 15 Aug 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: An interventional, phase I/II, multicenter, single-arm study

Arm	Type	Receives
dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen	Experimental	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. 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

Who may qualify

Ages: 28 days to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Age between 28 days and 10 years old
Weighing 3 to <25 kg
Confirmed HIV-1 infection (local, molecular methods)
A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study

Key exclusion criteria (15 listed)

Age between 28 days and 10 years old
Weighing 3 to <25 kg
Confirmed HIV-1 infection (local, molecular methods)
A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation 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
dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimenSwitch or start dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen with a novel dose ratio for HIV treatment	Drug	dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen
Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)Single arm	Drug	dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen

Primary outcome

Primary endpoints for DTG:
Time frame: From enrollment to the end of treatment at 24 weeks
- Geometric mean Ctrough concentration
Primary endpoints for DTG:
Time frame: From enrollment to the end of treatment at 24 weeks
Percentage of individual Ctrough concentrations below the 90% effective concentration (EC90) (0.32 mg/L)
Primary endpoints for DTG:
Time frame: From enrollment to the end of treatment at 24 weeks
- Geometric mean DTG Ctrough, Cmax, and AUC
Primary safety endpoints
Time frame: From enrollment to the end of treatment at 24 weeks
- Occurrence of serious adverse events
Primary safety endpoints
Time frame: From enrollment to the end of treatment at 24 weeks
- Occurrence of new clinical and laboratory grade 3 and 4 adverse events
Primary safety endpoints
Time frame: From enrollment to the end of treatment at 24 weeks
Occurrence of adverse events (of any grade) leading to treatment modification
Primary endpoints for FTC/TAF:
Time frame: From enrollment to the end of treatment at 24 weeks
- Geometric mean Ctrough, Cmax, and AUC
Primary endpoints for FTC/TAF:
Time frame: From enrollment to the end of treatment at 24 weeks
Intracellular tenofovir diphosphate (TDP) levels at 24 hours acquired through dried blood spot analysis

2 secondary outcomes

Efficacy endpoints
Time frame: From enrollment to the end of treatment at 24 weeks
Efficacy endpoints
Time frame: From enrollment to the end of treatment at 24 weeks

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 4 Mar 2026.
Derived from this study: PubMed 42705257Kamphuis AEM, Salvadori N, Mujuru HA, Bwakura-Dangarembizi M, Kisitu GP, Matovu F, Kaudha E, Mulindwa A, Jacobs TG, Than-In-At K, Cressey TR, Nardone A, Lallemant M, Colbers A, Burger DM; UNIVERSAL1 trial team. Expediting a UNIVERSAL first-line regimen of a dolutegravir-emtricitabine-tenofovir alafenamide fixed-dose ratio for children living with HIV older than 4 weeks: a 24-week, open-label, single-arm, phase 1-2, pharmacokinetic, safety, and antiviral activity trial. Lancet HIV. 2026 Sep 7:S2352-3018(26)00168-2. doi: 10.1016/S2352-3018(26)00168-2. Online ahead of print.
Individual participant dataSharing planned: No. IPD will be supporting a generic company dossier subject to FDA evaluation

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 15 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 4 Mar 2026. 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 Uganda, Zimbabwe. 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?

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?

Primary endpoints for DTG: (time frame: From enrollment to the end of treatment at 24 weeks). The study lists 8 primary outcomes in all. 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 NCT05993767, 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 4 Mar 2026.