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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427504
• Other study ID #: 11-1046
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: June 4, 2013
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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