Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers
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ClinicalTrials.gov Identifier: NCT01427504 |
Recruitment Status
:
Completed
First Posted
: September 1, 2011
Results First Posted
: July 9, 2013
Last Update Posted
: July 9, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C HIV | Drug: boceprevir; etravirine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | A Bioequivalence Study to Evaluate the Potential for Drug-drug Interactions Between Boceprevir 800mg Thrice Daily and the HIV Non-nucleoside Reverse Transcriptase Inhibitor Etravirine 200mg Twice Daily in HIV/(Hepatitis C Virus) (HCV) Negative Volunteers |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | March 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Sequence 1a
Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
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Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
|
Experimental: Sequence 1b
Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
|
Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
|
Experimental: Sequence 2a
Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
|
Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
|
Experimental: Sequence 2b
Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
|
Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
|
Experimental: Sequence 3a
Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
|
Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
|
Experimental: Sequence 3b
Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
|
Drug: boceprevir; etravirine
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
|
- Boceprevir AUC Pharmacokinetics [ Time Frame: 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 [ Time Frame: 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.
- Boceprevir C8 Pharmacokinetics [ Time Frame: 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.
- 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 ]Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.
- 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 ]Determine etravirine Cmax when administered alone
- 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 ]Determine etravirine Cmin when administered alone
- 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 ]Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone]
- 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 ]Determine boceprevir Cmax when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir alone]
- 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 ]Determine boceprevir 8 hour concentration when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir administered alone]
- 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 ]Determine etravirine AUC when coadministered with boceprevir. [Ratio = Etravirine administered with bocepreivr / etravirine administered alone]
- 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 ]Determine etravirine Cmax when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]
- 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 ]Determine etravirine Cmin when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427504
United States, Colorado | |
University of Colorado Anschutz Medical Campus | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Jennifer Kiser, PharmD | Univesity of Colorado Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01427504 History of Changes |
Other Study ID Numbers: |
11-1046 |
First Posted: | September 1, 2011 Key Record Dates |
Results First Posted: | July 9, 2013 |
Last Update Posted: | July 9, 2013 |
Last Verified: | June 2013 |
Keywords provided by University of Colorado, Denver:
HCV HIV |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Reverse Transcriptase Inhibitors Etravirine Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |