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

Not Applicable

Completed

• Conditions: Hepatitis C; HIV
• Interventions: Drug: boceprevir; etravirine

• Registration Number: NCT01427504
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Results First Submitted: 2012-11-16
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Results First Posted: 2013-07-09
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 3b	boceprevir; etravirine	Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
Sequence 1a	boceprevir; etravirine	Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
Sequence 1b	boceprevir; etravirine	Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
Sequence 2a	boceprevir; etravirine	Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
Sequence 2b	boceprevir; etravirine	Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
Sequence 3a	boceprevir; etravirine	Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.

Primary Outcome Measures

Name	Time	Method
Boceprevir C8 Pharmacokinetics	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14	Determine boceprevir 8 hour concentration when administered alone.
Boceprevir AUC Pharmacokinetics	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14	Determine boceprevir area-under-the concentration time curve (AUC) when administered alone.
Boceprevir Cmax Pharmacokinetics	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14	Determine the Cmax of boceprevir when administered alone.
Etravirine AUC Pharmacokinetics	Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14	Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.
Etravirine Cmax Pharmacokinetics	Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14	Determine etravirine Cmax when administered alone
Etravirine Cmin Pharmacokinetics	Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14	Determine etravirine Cmin when administered alone
Boceprevir AUC Pharmacokinetics Coadministered With Etravirine	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14	Determine boceprevir AUC when coadministered with etravirine. \[Ratio = boceprevir administered with etravirine/ boceprevir alone\]
Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14	Determine boceprevir Cmax when coadministered with etravirine. \[Ratio = boceprevir administered with etravirine / boceprevir alone\]
Boceprevir C8 Pharmacokinetics Coadministered With Etravirine	Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14	Determine boceprevir 8 hour concentration when coadministered with etravirine. \[Ratio = boceprevir administered with etravirine / boceprevir administered alone\]
Etravirine AUC Pharmacokinetics Coadministered With Boceprevir	Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14	Determine etravirine AUC when coadministered with boceprevir. \[Ratio = Etravirine administered with bocepreivr / etravirine administered alone\]
Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir	Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14	Determine etravirine Cmax when coadministered with boceprevir. \[Ratio = etravirine administered with boceprevir / etravirine administered alone\]
Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir	Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14	Determine etravirine Cmin when coadministered with boceprevir. \[Ratio = etravirine administered with boceprevir / etravirine administered alone\]

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States