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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1a | Experimental | Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine. |
|
| Sequence 1b | Experimental | Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only. |
|
| Sequence 2a | Experimental | Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine. |
|
| Sequence 2b | Experimental | Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only. |
|
| Sequence 3a | Experimental | Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only. |
|
| Sequence 3b | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| boceprevir; etravirine | Drug | boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Boceprevir AUC Pharmacokinetics Coadministered With Etravirine | Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Kiser, PharmD | Univesity of Colorado Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
There were 8 subjects that were excluded from trial before assignment to groups; 5 due to personal reasons, 2 due to elevated bilirubin, and 1 due to elevated serum creatinine.
Recruitment occured at the University of Colorado Hospital beginning September 1, 2011 and ended on October 4, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1a | Sequence 1,2,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started. |
| FG001 | Sequence 1b | Sequence 1,3,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started. |
| FG002 | Sequence 2a | Sequence 2,1,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started. |
| FG003 | Sequence 2b | Sequence 2,3,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started. |
| FG004 | Sequence 3a | Sequence 3,1,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started. |
| FG005 | Sequence 3b | Sequence 3,2,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1a | Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine. |
| BG001 | Sequence 1b | Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Boceprevir AUC Pharmacokinetics | Determine boceprevir area-under-the concentration time curve (AUC) when administered alone. | The number of participants was based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 |
|
|
4 months
Adverse events were verbally assessed by study investigators. Laboratory tests were performed at baseline and at all three intensive pharmacokinetic study visits. Clinical and laboratory adverse events were graded using the 2004 Division of AIDS table for grading the severity of adult and pediatric adverse experiences.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Boceprevir Alone | Subjects took boceprevir alone, 800 mg thrice daily, for 10-14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Grade 2 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered Taste | Gastrointestinal disorders | Serious, Mild/Mod | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Kiser | University of Colorado | 303-724-6131 | jennifer.kiser@ucdenver.edu |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C451734 | etravirine |
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Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only. |
|
| 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] | 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] | 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] | 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] | 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] | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14 |
| BG002 | Sequence 2a | Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine. |
| BG003 | Sequence 2b | Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only. |
| BG004 | Sequence 3a | Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only. |
| BG005 | Sequence 3b | Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Boceprevir Cmax Pharmacokinetics | Determine the Cmax of boceprevir when administered alone. | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 |
|
|
|
| Primary | Boceprevir C8 Pharmacokinetics | Determine boceprevir 8 hour concentration when administered alone. | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 |
|
|
|
| Primary | Etravirine AUC Pharmacokinetics | Determine etravirine area under the concentration vs. time curve (AUC)when administered alone. | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14 |
|
|
|
| Primary | Etravirine Cmax Pharmacokinetics | Determine etravirine Cmax when administered alone | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14 |
|
|
|
| Primary | Etravirine Cmin Pharmacokinetics | Determine etravirine Cmin when administered alone | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14 |
|
|
|
| Primary | Boceprevir AUC Pharmacokinetics Coadministered With Etravirine | Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone] | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 |
|
|
|
| Primary | Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine | Determine boceprevir Cmax when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir alone] | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 |
|
|
|
| Primary | Boceprevir C8 Pharmacokinetics Coadministered With Etravirine | Determine boceprevir 8 hour concentration when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir administered alone] | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14 |
|
|
|
| Primary | Etravirine AUC Pharmacokinetics Coadministered With Boceprevir | Determine etravirine AUC when coadministered with boceprevir. [Ratio = Etravirine administered with bocepreivr / etravirine administered alone] | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14 |
|
|
|
| Primary | Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir | Determine etravirine Cmax when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone] | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14 |
|
|
|
| Primary | Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir | Determine etravirine Cmin when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone] | The number of participants is based on the number of subjects that completed all three sequences of medication. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14 |
|
|
|
| 0 |
| 21 |
| 19 |
| 21 |
| EG001 | Etravirine Alone | Subjects took etravirine alone, 200 mg twice daily, for 10-14 days | 1 | 22 | 11 | 22 |
| EG002 | Boceprevir Coadministered With Etravirine | Boceprevir, 800 mg thrice daily, coadministered with etravirine, 200 mg twice daily for 10-14 days. | 5 | 25 | 21 | 25 |
| Increased energy, anxiety, nervousness, insomnia | Nervous system disorders | Serious, Mild/Mod | Systematic Assessment |
|
| Presumed Viral Illness | Gastrointestinal disorders | Serious, Mild/Mod | Systematic Assessment |
|
| Headache | General disorders | Serious, Mild/Mod | Systematic Assessment |
|
| Fatigue | General disorders | Serious, Mild/Mod | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Serious, Mild/Mod | Systematic Assessment |
|
| Hypokalemia | General disorders | Serious, Mild/Mod | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Serious, Mild/Mod | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |