VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer
Condition: Hepatitis C; HCV; HIV; AIDS
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of EFV (Efavirenz) and TDF (Tenofovir
      disoproxil fumarate) on the pharmacokinetics of TVR (Telaprevir) and to determine the effect
      of TVR on the pharmacokinetics of EFV and TDF. Pharmacokinetics means how the drug is
      absorbed into the bloodstream, distributed in the body and eliminated from the body.
      Furthermore, the short-term safety and tolerability of giving TVR, EFV and TDF together will
      be evaluated.
    

Detailed description: 
      The trial will enroll 20 Healthy volunteers. All participants will receive 4 different
      treatments:

      Treatment A: TVR every 8 hours alone for 6 days with an additional morning intake on Day 7.
      Treatment B: EFV + TDF once daily alone for 7 days. Treatment C: TVR every 8 hours + EFV once
      daily + TDF once daily for 7 days. Treatment D: TVR every 12 hours + EFV once daily + TDF
      once daily for 7 days.

      All participants will start with Treatment A followed by a 7 or 8-day washout period.
      Subsequently, participants will start with Treatment B. At the end of Treatment B,
      participants will be randomized (this is assigned to one of the two sequences by chance) to
      continue without a washout period with Sequence 1 (Treatment C followed by D without a
      washout) or Sequence 2 (Treatment D followed by C without a washout). Participants will thus
      receive daily EFV and TDF for a total of 21 consecutive days, with addition of 2 different
      dosages of TVR for the last 14 days.

      TVR will be taken with food, 30 minutes after the start of a meal. EFV and TDF should be
      taken on an empty stomach (2.5 hours after start of breakfast). Pharmacokinetic profiles of
      TVR and VRT-127394 (R-diastereomer of TVR) will be measured up to 8 hours after intake of the
      morning dose on Day 7 of Treatments A and C, and up to 12 hours after intake of the morning
      dose on Day 7 of Treatment D. Pharmacokinetic profiles of EFV and tenofovir will be measured
      up to 24 hours after intake on Day 7 of Treatments B, C, and D. Safety and tolerability
      evaluations will be recorded at regular intervals throughout the trial period. Treatment A:
      TVR every 8 hours alone for 6 days with an additional morning intake on Day 7. Treatment B:
      EFV + TDF once daily alone for 7 days. Treatment C: TVR every 8 hours + EFV once daily + TDF
      once daily for 7 days. Treatment D: TVR every 12 hours + EFV once daily + TDF once daily for
      7 days.
    

Intervention name(s): Efavirenz; Tenofovir disoproxil fumarate; Telaprevir
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir; Efavirenz
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; HIV; AIDS; Telaprevir; Efavirenz; Tenofovir disproxil fumarate; Healthy volunteer; VX-950-C134; VX-950-TiDP24-C134; HIV Infections