Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01427504
First received: August 24, 2011
Last updated: June 4, 2013
Last verified: June 2013
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Conditions: Hepatitis C
HIV
Intervention: Drug: boceprevir; etravirine

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sequence 1a Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
Sequence 1b Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
Sequence 2a Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
Sequence 2b Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
Sequence 3a Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
Sequence 3b Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
Total Total of all reporting groups

Baseline Measures
    Sequence 1a     Sequence 1b     Sequence 2a     Sequence 2b     Sequence 3a     Sequence 3b     Total  
Number of Participants  
[units: participants]
  4     3     4     6     3     6     26  
Age  
[units: participants]
             
<=18 years     0     0     1     0     0     0     1  
Between 18 and 65 years     4     3     3     6     3     6     25  
>=65 years     0     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.7  ± 13.4     35.6  ± 8.0     33.3  ± 9.8     25.9  ± 3.8     42.7  ± 16.8     32.4  ± 9.3     34.2  ± 10.9  
Gender  
[units: participants]
             
Female     1     2     0     3     2     6     14  
Male     3     1     4     3     1     0     12  
Region of Enrollment  
[units: participants]
             
United States     4     3     4     6     3     6     26  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Boceprevir AUC Pharmacokinetics   [ Time Frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 ]

2.  Primary:   Boceprevir Cmax Pharmacokinetics   [ Time Frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 ]

3.  Primary:   Boceprevir C8 Pharmacokinetics   [ Time Frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 ]

4.  Primary:   Etravirine AUC Pharmacokinetics   [ Time Frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14 ]

5.  Primary:   Etravirine Cmax Pharmacokinetics   [ Time Frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14 ]

6.  Primary:   Etravirine Cmin Pharmacokinetics   [ Time Frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14 ]

7.  Primary:   Boceprevir AUC Pharmacokinetics Coadministered With Etravirine   [ Time Frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 ]

8.  Primary:   Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine   [ Time Frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 ]

9.  Primary:   Boceprevir C8 Pharmacokinetics Coadministered With Etravirine   [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 ]

10.  Primary:   Etravirine AUC Pharmacokinetics Coadministered With Boceprevir   [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14 ]

11.  Primary:   Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir   [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14 ]

12.  Primary:   Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir   [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. Healthy volunteer study does not take into account other medications being prescribed to treat the co-infected population.
  2. An interaction at the level of enzyme induction is difficult to rule out since we sampled etravirine over 12 hours.


  More Information