Phase I, Double-Blind, Randomized, Placebo-Controlled Trial to Examine the Safety, Tolerability and Plasma Pharmacokinetics of Increasing Single Oral Doses of TMC558445 With and Without Food, and Increasing Repeated Oral Doses in Combination With a Single Dose of TMC310911.

Trial Profile

Phase I, Double-Blind, Randomized, Placebo-Controlled Trial to Examine the Safety, Tolerability and Plasma Pharmacokinetics of Increasing Single Oral Doses of TMC558445 With and Without Food, and Increasing Repeated Oral Doses in Combination With a Single Dose of TMC310911.

Completed
Phase of Trial: Phase I

Latest Information Update: 26 Apr 2010

At a glance

  • Drugs Darunavir; TMC 310911; TMC 558445
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics
  • Most Recent Events

    • 21 Nov 2009 Actual patient number (54) added as reported by ClinicalTrials.gov.
    • 21 Nov 2009 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 24 Jul 2009 Planned end date changed from 1 Jul 2009 to 1 Oct 2009 as reported by ClinicalTrials.gov.
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