Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/HCV Negative Volunteers



Status:Completed
Conditions:HIV / AIDS, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:August 2011
End Date:March 2012
Contact:Kyle P Hammond, PharmD
Email:kyle.hammond@ucdenver.edu
Phone:303-724-5564

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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


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.


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.

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
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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mi
from
Aurora, CO
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