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More info
You can access this
clinical trial
if you have
HIV Infections
and you are
between 18 and 55
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

The purpose of this study is to compare the drug levels of darunavir obtained after administration of a single administration of the 800 mg tablet (new formulation) to that following administration of two 400 mg commercial tablets formulation when administered under fed and fasted conditions to those also taking low-dose ritonavir. Darunavir is marketed for the treatment of HIV. The short-term safety and tolerability of darunavir following administration of a single 800 mg dose of darunavir given to healthy volunteers taking taking low-dose ritonavir will also be assessed.

Provided treatments

  • Drug: DRV commercial formulation/ DRV new formulation/ rtv 100mg tab
  • Drug: DRV commercial formulation/ DRV new formulation/ rtv 100mg tab
  • Drug: DRV commercial formulation/ DRV new formulation/ rtv 100mg tab
  • Drug: DRV commercial formulation/ DRV new formulation/ rtv 100mg tab

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01052883. The sponsor of the trial is Tibotec Pharmaceuticals, Ireland and it is looking for 32 volunteers for the current phase.
Official trial title:
A Phase I, Open Label, Randomized, Single Dose, Crossover Study in Healthy Subjects to Compare the Oral Bioavailability of a Prototype Tablet Formulation of Darunavir 800mg(G002) to That of the Commercial 400mg(F030) Tablet Formulation Under Fed & Fasted Conditions, in Presence of Low-dose Ritonavir