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Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV

WithdrawnPhase 1, Phase 2

Sponsor: PENTA Foundation

Conditions: HIV Infections

Interventions: DRV/r FDC (120/20mg)

Countries: Cameroon, Senegal, Uganda, Zimbabwe

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.

Eligibility overview

Sex: ALL

Age: 3 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* • 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
  * 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

Exclusion Criteria:

* 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, …).

Locations (5)

Yaoundé, Cameroon, Cameroon
Dakar, Senegal, Senegal
Kampala, Uganda, Uganda
Kampala, Uganda
Harare, Zimbabwe, Zimbabwe