HIV InfectionsPhase 1/2UNIVERSAL2NCT06139796
Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV
A Phase 1/2 study testing DRV/r FDC (120/20mg) in people with HIV Infections, run by PENTA Foundation at 5 sites in 4 countries.
Trial summary
The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- DRV/r FDC (120/20mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Feb 2025to 9 Jul 2025
- Phase
- Phase 1/2
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Confirmed HIV-1 infection
- Aged ≥ 3 years
- With unsuppressed viral load (HIV-1 RNA viral load > 1000 c/mL) on ART-regimen and eligible to switch to new DRV/r 120/20 mg-based regimen per investigator's judgement
- Able to swallow the 120/20 mg DRV/r tablets
- Willing to receive the 120/20 mg DRV/r tablets
- Parents or guardians, and children where appropriate, willing and able to give informed consent and to adhere to the protocol
Show all 13Show fewer
- Cohort-specific inclusion criteria:
- Cohort A:
- Have 1 or 2 DRV resistance-associated mutations (RAMs)*
- Weigh 10 to <25 kg at screening
- Cohort B:
- Have no DRV RAMs*
- Weigh 10 to <20 kg at screening. *DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
Who cannot join
- Presence of >2 darunavir RAMs*
- Failure of protease genotypic resistance testing at baseline, except if treatment history indicates that it is very unlikely
- Resistance to all NRTI available in the country or impossibility to define an OBT
- Intercurrent illness (enrolment can take place after the illness resolves)
- Creatinine ≥ 1.8 Upper Limit of Normal (ULN) or ALT ≥ 5 ULN or (ALT ≥ 3 ULN and bilirubin ≥2 ULN) at screening.
- Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- History or presence of known allergy or other contraindication to DRV/r or their components as described in the Summary of Product Characteristics (SmPC)
- Concomitant medications that may interact with the current antiretroviral treatment, in particular TB drugs (i.e: rifampicin, rifabutin, rifapentine, …).
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Uganda2 sites
Baylor College of Medicine Children's Foundation
Kampala, Uganda, 72052
Joint Clinical Research Centre (JCRC)
Kampala
Cameroon1 site
Centre Mère et Enfant de la Fondation Chantal Biya
Yaoundé, Cameroon, 1
Senegal1 site
Centre Hospitalier National d'Enfants Albert Royer
Dakar, Senegal, 25755
Zimbabwe1 site
University of Zimbabwe Clinical Research Centre (UZCRC)
Harare, Zimbabwe
About this study
Official title: Pharmacokinetics, Safety and Acceptability of a Solid Paediatric Fixed-dose Combination of Darunavir/Ritonavir (DRV/r) 120/20 mg for Children Living With HIV
The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
Read the detailed description
The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
It is a combination of two anti-HIV medicines called darunavir (DRV) and ritonavir (RTV). The DRV/RTV combination is well known and has been used for a long time in adults and children to treat HIV infection but there is no combined pediatric formulation that has been adapted to the needs of children ("child friendly" formulation).
The new combination has been developed in the form of fixed-dose combination tablets with a dose of 120 mg of DRV and 20 mg of RTV (DRV/RTV 120/20) in each tablet. Depending on their weight and the need to take the medication once or twice a day, children may receive 2, 3 or 4 DRV/RTV 120/20 tablets at any given time.
The aim of UNIVERSAL2 is to determine the correct dosage and to assess the safety and acceptability of the new drug for children living with HIV.
The study will focus on two groups of children.
- Group A will include children with one or two specific viral genetic mutations linked to DRV resistance and will receive DRV/RTV twice daily.
- Group B will include children without DRV resistance viral gene mutations who will receive DRV/RTV once daily.
All children will start taking the DRV/r at the beginning of the study. After two weeks, participants will be invited to stay at the clinic for blood samples to be taken at different times of the day in order to understand how the drug is absorbed, metabolised and excreted in the body (pharmacokinetic tests). They will then continue to be monitored at the clinic several times over a 24-week period, with additional blood tests to be sure children are tolerating the drug well and that it helps to control HIV replication. Participants and their carers will also be asked to answer some questions to determine how acceptable the new tablets are to children and carers.
- Conditions
- HIV Infections
- Being tested
- DRV/r FDC (120/20mg)
- Keywords
- HIV, Darunavir, Ritonavir, Paediatrics, new formulation
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRV/r FDC (120/20mg)Drug
Initiation of DRV/r FDC (120/20mg) as part of antiretroviral therapy (ART) with an Optimized Background Therapy (OBT)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Twice daily | Experimental | DRV/r twice daily (BID): 30 children with 1 or 2 DRV RAM* weighing 10 to <25 kg (10 per weight band: 10-13.9kg, 14-19.9kg, 20-24.9kg) Receives: Drug: DRV/r FDC (120/20mg) |
| Cohort B Once daily | Experimental | DRV/r once daily (OD): 20 children with no DRV RAM* weighing 10 to <20 kg (10 per weight band: 10-13.9kg, 14-19.9kg)
*DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V Receives: Drug: DRV/r FDC (120/20mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Darunavir
area under the concentration-time curve (AUC0-12) (Cohort A)
Measured: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Darunavir
area under the concentration-time curve (AUC0-24) (Cohort B)
Measured: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Darunavir
maximum plasma concentration (Cmax)
Measured: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Darunavir
12 hours or 24 hours post dose concentrations (C12 or C24)
Measured: From enrollment to the end of treatment at 24 weeks
Safety events
serious adverse events (SAEs)
Measured: From enrollment to the end of treatment at 24 weeks
Safety events
adverse events (AEs) of Grade 3 or higher
Measured: From enrollment to the end of treatment at 24 weeks
Safety events
treatment related AEs
Measured: From enrollment to the end of treatment at 24 weeks
Safety events
AEs leading to treatment discontinuation or modification
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (5)
Acceptability
Questionnaire
Measured: From enrollment to the end of treatment at 24 weeks
Efficacy of treatment
HIV-1 RNA <50 c/mL and <400 c/mL
Measured: From enrollment to the end of treatment at 24 weeks
Efficacy of treatment
Occurrence of a new or recurrent WHO clinical stage 3 or 4 event
Measured: From enrollment to the end of treatment at 24 weeks
Efficacy of treatment
Change in CD4 cell count and percentage from baseline to week 24
Measured: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Ritonavir
RTV PK parameters and DRV unbound concentrations
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.
- First posted18 Nov 2023
- Study start1 Feb 2025
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Why it stopped: Study not started as the IMP is re-worked by the manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Open-label, multi-centre, single-arm, phase I/II study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Collaborators
- AMS-PHPT Research Collaboration, Institut National de la Santé Et de la Recherche Médicale, France, Centre Mère et Enfant de la Fondation Chantal Biya, Centre Hospitalier National d'Enfants Albert Royer, University of Zimbabwe Clinical Research Centre (UZCRC), Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Albert Faye, Study chair, Hôpital Robert Debré and Université Paris Cité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139796
- Sponsor's protocol ID
- UNIVERSAL2
- Acronym
- UNIVERSAL2
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2023
- Last updated
- 5 Mar 2026
- 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 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety and Acceptability of a Solid Paediatric Fixed-dose Combination of Darunavir/Ritonavir (DRV/r) 120/20 mg for Children Living With HIV
- ClinicalTrials.gov ID
- NCT06139796
- Acronym / sponsor ID
- UNIVERSAL2 / UNIVERSAL2
- Conditions
- HIV Infections
- Keywords
- HIV, Darunavir, Ritonavir, Paediatrics, new formulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started as the IMP is re-worked by the manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Collaborators
- AMS-PHPT Research Collaboration, Institut National de la Santé Et de la Recherche Médicale, France, Centre Mère et Enfant de la Fondation Chantal Biya, Centre Hospitalier National d'Enfants Albert Royer, University of Zimbabwe Clinical Research Centre (UZCRC), Baylor College of Medicine
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 18 Nov 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.
The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
Detailed description
The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
It is a combination of two anti-HIV medicines called darunavir (DRV) and ritonavir (RTV). The DRV/RTV combination is well known and has been used for a long time in adults and children to treat HIV infection but there is no combined pediatric formulation that has been adapted to the needs of children ("child friendly" formulation).
The new combination has been developed in the form of fixed-dose combination tablets with a dose of 120 mg of DRV and 20 mg of RTV (DRV/RTV 120/20) in each tablet. Depending on their weight and the need to take the medication once or twice a day, children may receive 2, 3 or 4 DRV/RTV 120/20 tablets at any given time.
The aim of UNIVERSAL2 is to determine the correct dosage and to assess the safety and acceptability of the new drug for children living with HIV.
The study will focus on two groups of children.
- Group A will include children with one or two specific viral genetic mutations linked to DRV resistance and will receive DRV/RTV twice daily.
- Group B will include children without DRV resistance viral gene mutations who will receive DRV/RTV once daily.
All children will start taking the DRV/r at the beginning of the study. After two weeks, participants will be invited to stay at the clinic for blood samples to be taken at different times of the day in order to understand how the drug is absorbed, metabolised and excreted in the body (pharmacokinetic tests). They will then continue to be monitored at the clinic several times over a 24-week period, with additional blood tests to be sure children are tolerating the drug well and that it helps to control HIV replication. Participants and their carers will also be asked to answer some questions to determine how acceptable the new tablets are to children and carers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, multi-centre, single-arm, phase I/II study
| Arm | Type | Receives |
|---|---|---|
| Cohort A Twice daily | Experimental | Drug: DRV/r FDC (120/20mg)DRV/r twice daily (BID): 30 children with 1 or 2 DRV RAM* weighing 10 to <25 kg (10 per weight band: 10-13.9kg, 14-19.9kg, 20-24.9kg) |
| Cohort B Once daily | Experimental | Drug: DRV/r FDC (120/20mg)DRV/r once daily (OD): 20 children with no DRV RAM* weighing 10 to <20 kg (10 per weight band: 10-13.9kg, 14-19.9kg) *DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- • Confirmed HIV-1 infection
- Have 1 or 2 DRV resistance-associated mutations (RAMs)*
- Weigh 10 to <25 kg at screening
- Have no DRV RAMs*
- Weigh 10 to <20 kg at screening. *DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
Key exclusion criteria (8 listed)
- Presence of >2 darunavir RAMs*
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 |
|---|---|---|
| DRV/r FDC (120/20mg)Initiation of DRV/r FDC (120/20mg) as part of antiretroviral therapy (ART) with an Optimized Background Therapy (OBT) | Drug | Cohort A Twice daily, Cohort B Once daily |
Primary outcome
Pharmacokinetics Darunavir
Time frame: From enrollment to the end of treatment at 24 weeks
area under the concentration-time curve (AUC0-12) (Cohort A)
Pharmacokinetics Darunavir
Time frame: From enrollment to the end of treatment at 24 weeks
area under the concentration-time curve (AUC0-24) (Cohort B)
Pharmacokinetics Darunavir
Time frame: From enrollment to the end of treatment at 24 weeks
maximum plasma concentration (Cmax)
Pharmacokinetics Darunavir
Time frame: From enrollment to the end of treatment at 24 weeks
12 hours or 24 hours post dose concentrations (C12 or C24)
Safety events
Time frame: From enrollment to the end of treatment at 24 weeks
serious adverse events (SAEs)
Safety events
Time frame: From enrollment to the end of treatment at 24 weeks
adverse events (AEs) of Grade 3 or higher
Safety events
Time frame: From enrollment to the end of treatment at 24 weeks
treatment related AEs
Safety events
Time frame: From enrollment to the end of treatment at 24 weeks
AEs leading to treatment discontinuation or modification
5 secondary outcomes
Acceptability
Time frame: From enrollment to the end of treatment at 24 weeks
Efficacy of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Efficacy of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Efficacy of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Ritonavir
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- 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.
Albert Faye study chair
Hôpital Robert Debré and Université Paris Cité
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DRV/r FDC (120/20mg) in people with HIV Infections, run by PENTA Foundation at 5 sites in 4 countries.
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 13 inclusion and 8 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: withdrawn, as of the sponsor's last update on 5 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 5 sites in Uganda, Cameroon, Senegal, 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetics Darunavir (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?
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 5 Mar 2026.