TMC125-TiDP2-C188: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Effect of Multiple-dose TMC125 on Buprenorphine and Norbuprenorphine Administered in HIV-negative Patients on Stable Buprenorphine/Naloxone Maintenance Therapy.
Condition: HIV; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      TMC125 is from the class of drugs called non-nucleoside reverse transcriptase inhibitors
      (NNRTIs). NNRTIs work by blocking reverse transcriptase, a protein that HIV needs to make
      more copies of itself. TMC125 is used in the treatment of adults with HIV-1 infection. The
      purpose of this trial is to see if there is any potential interaction (change in the
      effectiveness of the drug) when taking multiple-dose TMC125 and buprenorphine/naloxone
      together. The trial will also assess the short-term safety and tolerability (how well your
      body handles the drug) when TMC125 and buprenorphine/naloxone are taken together.
    

Detailed description: 
      This is a Phase I, open-label (patient and trial doctor know what medication you are taking
      at any point in time during the trial), add-on trial in patients who are on stable sublingual
      (placed in the mouth under the tongue until it disolves) buprenorphine/naloxone maintenance
      therapy, to investigate the potential pharmacokinetic effect of multiple-dose TMC125 on
      buprenorphine and norbuprenorphine administered as buprenorphine/naloxone. The study
      population will consist of 16 HIV-negative opioid-dependent patients on stable individualized
      sublingual buprenorphine/naloxone maintenance therapy. Patients will first participate in a 2
      weeks run-in period with supervised buprenorphine/naloxone intake. Subsequently, patients
      will receive TMC125 200 mg orally twice daily for 14 days added to their
      buprenorphine/naloxone treatment. During the treatment period from Day 1 to Day 14, the
      individualized buprenorphine/naloxone treatment will be continued with co-administration of
      TMC125. Full pharmacokinetic profiles of buprenorphine and norbuprenorphine will be
      determined on Days -1 and 14 up to 24 hours postdose. Full pharmacokinetic profiles of TMC125
      will be determined on Day 14 up to 12 hours postdose. Pharmacodynamic assessments of symptoms
      of opiate withdrawal and excess will be performed. The short-term safety and tolerability
      will be assessed throughout the trial. Patients will firstparticipate in a 2 weeks run-in
      period with supervised buprenorphine/naloxone intake. Subsequently, patients will receive 2
      tablets of 100 mg TMC125 twice daily for 14 days added to their buprenorphine/naloxone
      treatment. During the treatment period from Day 1 to Day 14, the individualized
      buprenorphine/naloxone treatment will be continued with co-administration of TMC125.
    

Intervention name(s): TMC125
Intervention type(s): Drug
Intervention MeSH terms: Etravirine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-negative; buprenorphine/nalaxone; norbuprenorphine; opioid-dependent; TMC125-TiDP2-C188; TMC125-C188; TMC125; HIV Infections