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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 the study is to determine the safety, tolerability, and plasma pharmacokinetics (i.e., the levels of TMC589337 and TMC589354 circulating in your blood over time) of increasing single oral doses of TMC589337 and TMC589354 and of multiple increasing oral doses followed by a single dose of TMC310911 to assess the potential boosting effect on the latter compound. In this study 3 investigational new drugs are involved. These new investigational drugs called TMC589337 and TMC589354 (from the PEPI family) and TMC310911 are in process of development for the treatment of Human Immunodeficiency Virus-Type 1 (HIV-1). TMC589337 and TMC589354 are novel molecules with no antiviral activity to be used to enhance the pharmacokinetics profile of a drug. TMC310911 is a novel and potent compound and belongs to a medication class called protease inhibitors (PI).

Provided treatments

  • Drug: TMC589337 40 mg
  • Drug: TMC589337 100 mg
  • Drug: TMC589337 200 mg
  • Drug: TMC589337 400 mg
  • Drug: TMC589354 40 mg
  • Drug: TMC589354 100 mg
  • Drug: TMC589354 200 mg
  • Drug: TMC589354 400 mg
  • Drug: TMC589337 AA mg
  • Drug: TMC589354 BB mg
  • Drug: TMC589337 CC mg
  • Drug: TMC589354 DD mg
  • Drug: TMC589337 EE mg
  • Drug: TMC589354 YY mg
  • Drug: TMC310911 300 mg
  • Drug: TMC310911 600 mg
  • Drug: Placebo
Tris trial is registered with FDA with number: NCT00908414. The sponsor of the trial is Tibotec Pharmaceuticals, Ireland and it is looking for 0 volunteers for the current phase.
Official trial title:
Phase I, Double-blind, Randomized, Placebo-controlled Trial in Healthy Volunteers to Examine Safety, Tolerability, Plasma Pharmacokinetics of TMC589337&TMC589354 After Increasing Single Oral Doses & in an Open-label Part After Different Repeated Doses in Combination With Single Oral Dose of TMC310911