A Phase 1/2 interventional study of DRV/r FDC (120/20mg) in HIV Infections, sponsored by PENTA Foundation. Withdrawn at 5 sites in 4 countries. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by PENTA Foundation · Phase 1/2, Interventional, and Treatment
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.
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
Browse HIV Infections studies →PENTA Foundation is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Confirmed -1 infection
Cohort A:
Cohort B:
Exclusion Criteria:
Presence of >2 darunavir RAMs*
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.
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.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
Drug: DRV/r FDC (120/20mg)
Initiation of DRV/r FDC (120/20mg) as part of antiretroviral therapy (ART) with an Optimized Background Therapy (OBT)
Pharmacokinetics Darunavir
area under the concentration-time curve (AUC0-12) (Cohort A)
Time frame: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Darunavir
area under the concentration-time curve (AUC0-24) (Cohort B)
Time frame: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Darunavir
maximum plasma concentration (Cmax)
Time frame: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Darunavir
12 hours or 24 hours post dose concentrations (C12 or C24)
Time frame: From enrollment to the end of treatment at 24 weeks
Safety events
serious adverse events (SAEs)
Time frame: From enrollment to the end of treatment at 24 weeks
Safety events
adverse events (AEs) of Grade 3 or higher
Time frame: From enrollment to the end of treatment at 24 weeks
Safety events
treatment related AEs
Time frame: From enrollment to the end of treatment at 24 weeks
Safety events
AEs leading to treatment discontinuation or modification
Time frame: From enrollment to the end of treatment at 24 weeks
Acceptability
Questionnaire
Time frame: From enrollment to the end of treatment at 24 weeks
Efficacy of treatment
HIV-1 RNA \<50 c/mL and \<400 c/mL
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at 24 weeks
Pharmacokinetics Ritonavir
RTV PK parameters and DRV unbound concentrations
Time frame: From enrollment to the end of treatment at 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
PENTA Foundation