Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/HCV Negative Volunteers
This study has been completed.
Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01427504
First received: August 24, 2011
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hepatitis C HIV |
Drug: boceprevir; etravirine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: 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/HCV Negative Volunteers |
Resource links provided by NLM:
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Determine bioequivalence of boceprevir [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Determine the bioequivalence of boceprevir area-under-the concentration time curve (AUC), maximum concentration (Cmax), and trough concentration (Ctrough) with and without coadministration of etravirine.
Secondary Outcome Measures:
- Determine Bioequivalence of etravirine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Determine the bioequivalence of etravirine AUC, Cmax, and Ctrough with and without coadministration of boceprevir.
| Enrollment: | 26 |
| Study Start Date: | August 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sequence 1a
Sequence 1,2,3: boceprevir only, then etravirine 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 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 ("DAIDS grading table) 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427504
Locations
| United States, Colorado | |
| University of Colorado Anschutz Medical Campus | |
| Aurora, Colorado, United States, 80045 | |
Sponsors and Collaborators
University of Colorado, Denver
Investigators
| Principal Investigator: | Jennifer Kiser, PharmD | Univesity of Colorado Denver |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01427504 History of Changes |
| Other Study ID Numbers: | 11-1046 |
| Study First Received: | August 24, 2011 |
| Last Updated: | October 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013