Hepatitis CNCT01427504

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

A study testing boceprevir; etravirine in people with Hepatitis C and HIV, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis C, HIV
What is being tested?: boceprevir; etravirine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Mar 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

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

Read the 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.

Conditions: Hepatitis C, HIV
Being tested: boceprevir; etravirine
Keywords: HCV, HIV
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

boceprevir; etravirineDrug
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Study groups in NCT01427504
Study group	Role	What they receive
Sequence 1a	Experimental	Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine. Receives: Drug: boceprevir; etravirine
Sequence 1b	Experimental	Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only. Receives: Drug: boceprevir; etravirine
Sequence 2a	Experimental	Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine. Receives: Drug: boceprevir; etravirine
Sequence 2b	Experimental	Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only. Receives: Drug: boceprevir; etravirine
Sequence 3a	Experimental	Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only. Receives: Drug: boceprevir; etravirine
Sequence 3b	Experimental	Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only. Receives: Drug: boceprevir; etravirine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Mar 2012

First posted1 Sep 2011 (estimated)
Study startAug 2011
Primary completionDec 2011
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01427504
Sponsor's protocol ID: 11-1046
Status last verified: Jun 2013
First submitted: 24 Aug 2011
Last updated: 9 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01427504
Acronym / sponsor ID: 11-1046
Conditions: Hepatitis C, HIV
Keywords: HCV, HIV
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: Aug 2011
Primary completion: Dec 2011 (actual)
Study completion: Mar 2012 (actual)
First posted: 1 Sep 2011 (estimated)
Results: Posted 9 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1a	Experimental	Drug: boceprevir; etravirineSequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
Sequence 1b	Experimental	Drug: boceprevir; etravirineSequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
Sequence 2a	Experimental	Drug: boceprevir; etravirineSequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
Sequence 2b	Experimental	Drug: boceprevir; etravirineSequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
Sequence 3a	Experimental	Drug: boceprevir; etravirineSequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
Sequence 3b	Experimental	Drug: boceprevir; etravirineSequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
boceprevir; etravirineboceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.	Drug	Sequence 1a, Sequence 1b, Sequence 2a, Sequence 2b, Sequence 3a, Sequence 3b

Primary outcome

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]

Results and safety

Results posted to the registry on 9 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1a	4	4
Sequence 1b	3	2
Sequence 2a	4	3
Sequence 2b	6	5
Sequence 3a	3	2
Sequence 3b	6	4

Primary outcome: Boceprevir AUC Pharmacokinetics

Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Boceprevir AUC n = 20
Value	4601 (47)

Population analysed: The number of participants was based on the number of subjects that completed all three sequences of medication.

Primary outcome: Boceprevir Cmax Pharmacokinetics

Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Boceprevir Cmax n = 20
Value	1423 (43)

Population analysed: The number of participants is based on the number of subjects that completed all three sequences of medication.

Primary outcome: Boceprevir C8 Pharmacokinetics

Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Boceprevir C8 n = 20
Value	106 (64)

Population analysed: The number of participants is based on the number of subjects that completed all three sequences of medication.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Etravirine AUC n = 20
Value	7698 (33)

Population analysed: The number of participants is based on the number of subjects that completed all three sequences of medication.

Adverse events

Time frame: 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boceprevir Alone	0 of 21 (0%)	19 of 21 (90.5%)	Not reported
Etravirine Alone	1 of 22 (4.5%)	11 of 22 (50%)	Not reported
Boceprevir Coadministered With Etravirine	5 of 25 (20%)	21 of 25 (84%)	Not reported

Limitations and caveats (from the sponsor): 1. Healthy volunteer study does not take into account other medications being prescribed to treat the co-infected population. 2. An interaction at the level of enzyme induction is difficult to rule out since we sampled etravirine over 12 hours.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Kiser, PharmD principal investigator

Univesity of Colorado Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing boceprevir; etravirine in people with Hepatitis C and HIV, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boceprevir AUC Pharmacokinetics (time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01427504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.