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

NCT ID: NCT01427504

Last Updated: 2013-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-03-31

Brief Summary

The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine. The investigators believe that etravirine's drug concentrations will be increased when administered in combination with boceprevir. Additionally, the investigators believe that boceprevir and etravirine are safe when administered alone or in combination.

Detailed Description

To investigate the potential for drug interactions between boceprevir and etravirine, participants will receive each drug alone and the drugs in combination for 11-14 days. The pharmacokinetics of boceprevir and etravirine when given in combination vs. alone will be compared.

Conditions

Hepatitis C; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Sequence 1a

Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.

Group Type: EXPERIMENTAL

boceprevir; etravirine

Intervention Type: DRUG

boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Sequence 1b

Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.

Group Type: EXPERIMENTAL

boceprevir; etravirine

Intervention Type: DRUG

boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Sequence 2a

Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.

Group Type: EXPERIMENTAL

boceprevir; etravirine

Intervention Type: DRUG

boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Sequence 2b

Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.

Group Type: EXPERIMENTAL

boceprevir; etravirine

Intervention Type: DRUG

boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Sequence 3a

Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.

Group Type: EXPERIMENTAL

boceprevir; etravirine

Intervention Type: DRUG

boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Sequence 3b

Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.

Group Type: EXPERIMENTAL

boceprevir; etravirine

Intervention Type: DRUG

boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Interventions

boceprevir; etravirine

boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women ages 18-60 years
• Absence of HIV-1 and HCV antibodies at screening
• Ability and willingness to give written informed consent before the first trial-related activity

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements.
• Participation in any investigation drug study within 30 days prior to study.
• Currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results.
• Use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions:aspirin, acetaminophen, once daily multivitamins, mineral supplements and hormonal oral contraceptives (other than those that contain drospirenone). Concomitant medications other than those listed above must have been discontinued at least 14 days before study entry.
• Currently active dermatitis or urticaria or diagnosis of eczema or psoriasis.
• History of significant drug allergy (i.e., anaphylaxis and/or angioedema)
• Subjects with the following laboratory abnormalities at screening as defined by the 2004 Division of AIDS Table for grading the Severity of Adult and Pediatric Adverse Events and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (>1.1 x upper limit of laboratory normal range (ULN); hemoglobin grade 1 or greater (≤ 10.9 g/dL); platelet count grade 1 or greater (≤ 124.999 x 109/L); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN); total bilirubin grade 1 or greater (≥ 1.1 x ULN), any other laboratory abnormality of grade 2 or above

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Kiser, PharmD

Role: PRINCIPAL_INVESTIGATOR

Univesity of Colorado Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

11-1046

Identifier Type: -

Identifier Source: org_study_id