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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT01427504
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 6
• Duration (Months): 7
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C; HIV	Drug: boceprevir; etravirine	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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/(Hepatitis C Virus) (HCV) Negative Volunteers
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Boceprevir AUC Pharmacokinetics [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.

2. Boceprevir Cmax Pharmacokinetics [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.

3. Boceprevir C8 Pharmacokinetics [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.

4. Etravirine AUC Pharmacokinetics [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.

5. Etravirine Cmax Pharmacokinetics [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

6. Etravirine Cmin Pharmacokinetics [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

7. Boceprevir AUC Pharmacokinetics Coadministered With Etravirine [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]

8. Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine [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]

9. Boceprevir C8 Pharmacokinetics Coadministered With Etravirine [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]

10. Etravirine AUC Pharmacokinetics Coadministered With Boceprevir [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]

11. Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir [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]

12. Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir [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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT01427504
• Other Study ID Numbers: 11-1046
• First Posted: Sep 1, 2011
• Last Update Posted: Jul 9, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by University of Colorado, Denver: HCV; HIV
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Etravirine

Study Results

Participant Flow

Recruitment Details	Recruitment occured at the University of Colorado Hospital beginning September 1, 2011 and ended on October 4, 2011.
Pre-assignment Detail	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.

Arm/Group Title	Sequence 1a	Sequence 1b	Sequence 2a	Sequence 2b	Sequence 3a	Sequence 3b
Arm/Group Description	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.	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.	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.	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.	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.	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.
Period Title: Overall Study
STARTED	4	3	4	6	3	6
Received Boceprevir	4	3	3	5	2	4
Received Etravirine	4	2	4	6	2	4
Received Combination	4	3	3	6	3	6
COMPLETED	4	2	3	5	2	4
NOT COMPLETED	0	1	1	1	1	2

Baseline Characteristics

Arm/Group Title	Sequence 1a	Sequence 1b	Sequence 2a	Sequence 2b	Sequence 3a	Sequence 3b	Total
Arm/Group Description	Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.	Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.	Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.	Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.	Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.	Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.	Total of all reporting groups
Overall Participants	4	3	4	6	3	6	26
Age (Count of Participants)
<=18 years	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	1 3.8%
Between 18 and 65 years	4 100%	3 100%	3 75%	6 100%	3 100%	6 100%	25 96.2%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.7 (13.4)	35.6 (8.0)	33.3 (9.8)	25.9 (3.8)	42.7 (16.8)	32.4 (9.3)	34.2 (10.9)
Sex: Female, Male (Count of Participants)
Female	1 25%	2 66.7%	0 0%	3 50%	2 66.7%	6 100%	14 53.8%
Male	3 75%	1 33.3%	4 100%	3 50%	1 33.3%	0 0%	12 46.2%
Region of Enrollment (participants) [Number]
United States	4 100%	3 100%	4 100%	6 100%	3 100%	6 100%	26 100%

Outcome Measures

1. Primary Outcome

Title	Boceprevir AUC Pharmacokinetics
Description	Determine boceprevir area-under-the concentration time curve (AUC) when administered alone.
Time Frame	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boceprevir AUC
Arm/Group Description	Geometric mean of boceprevir AUC administered alone.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	4601 (47)

2. Primary Outcome

Title	Boceprevir Cmax Pharmacokinetics
Description	Determine the Cmax of boceprevir when administered alone.
Time Frame	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boceprevir Cmax
Arm/Group Description	Geometric mean of boceprevir Cmax when administered alone.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	1423 (43)

3. Primary Outcome

Title	Boceprevir C8 Pharmacokinetics
Description	Determine boceprevir 8 hour concentration when administered alone.
Time Frame	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boceprevir C8
Arm/Group Description	Geometric mean of boceprevir Cmax when administered alone.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	106 (64)

4. Primary Outcome

Title	Etravirine AUC Pharmacokinetics
Description	Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.
Time Frame	Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Etravirine AUC
Arm/Group Description	Geometric mean of etravirine AUC when administered alone.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	7698 (33)

5. Primary Outcome

Title	Etravirine Cmax Pharmacokinetics
Description	Determine etravirine Cmax when administered alone
Time Frame	Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Etravirine Cmax
Arm/Group Description	Geometric mean of etravirine Cmax when administered alone.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	900 (29)

6. Primary Outcome

Title	Etravirine Cmin Pharmacokinetics
Description	Determine etravirine Cmin when administered alone
Time Frame	Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Etravirine Cmin
Arm/Group Description	Geometric mean of etravirine Cmin when administered alone.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	439 (46)

7. Primary Outcome

Title	Boceprevir AUC Pharmacokinetics Coadministered With Etravirine
Description	Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone]
Time Frame	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boceprevir AUC Coadministered With Etravirine
Arm/Group Description	Geometric mean ratio of boceprevir AUC when coadministered with etravirine
Measure Participants	20
Geometric Mean (90% Confidence Interval) [Ratio]	1.10

8. Primary Outcome

Title	Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine
Description	Determine boceprevir Cmax when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir alone]
Time Frame	Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boceprevir Cmax Coadministered With Etravirine
Arm/Group Description	Geometric mean ratio of boceprevir Cmax when coadministered with etravirine
Measure Participants	20
Geometric Mean (90% Confidence Interval) [Ratio]	1.10

9. Primary Outcome

Title	Boceprevir C8 Pharmacokinetics Coadministered With Etravirine
Description	Determine boceprevir 8 hour concentration when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir administered alone]
Time Frame	Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boceprevir C8 Coadministered With Etravirine
Arm/Group Description	Geometric mean ratio of boceprevir C8 when coadministered with etravirine
Measure Participants	20
Geometric Mean (90% Confidence Interval) [Ratio]	0.88

10. Primary Outcome

Title	Etravirine AUC Pharmacokinetics Coadministered With Boceprevir
Description	Determine etravirine AUC when coadministered with boceprevir. [Ratio = Etravirine administered with bocepreivr / etravirine administered alone]
Time Frame	Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Etravirine AUC Coadministered With Boceprevir
Arm/Group Description	Geometric mean ratio of etravirine AUC when coadministered with boceprevir
Measure Participants	20
Geometric Mean (90% Confidence Interval) [Ratio]	0.77

11. Primary Outcome

Title	Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir
Description	Determine etravirine Cmax when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]
Time Frame	Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Etravirine Cmax
Arm/Group Description	Geometric mean ratio of etravirine Cmax when coadministered with boceprevir
Measure Participants	20
Geometric Mean (90% Confidence Interval) [Ratio]	0.76

12. Primary Outcome

Title	Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir
Description	Determine etravirine Cmin when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]
Time Frame	Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Etravirine Cmin Coadministered With Boceprevir
Arm/Group Description	Geometric mean ratio of etravirine Cmin when coadministered with boceprevir
Measure Participants	20
Geometric Mean (90% Confidence Interval) [Ratio]	0.71

Adverse Events

Time Frame	4 months
Adverse Event Reporting Description	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.
Arm/Group Title	Boceprevir Alone		Etravirine Alone		Boceprevir Coadministered With Etravirine
Arm/Group Description	Subjects took boceprevir alone, 800 mg thrice daily, for 10-14 days.		Subjects took etravirine alone, 200 mg twice daily, for 10-14 days		Boceprevir, 800 mg thrice daily, coadministered with etravirine, 200 mg twice daily for 10-14 days.
All Cause Mortality
	Boceprevir Alone		Etravirine Alone		Boceprevir Coadministered With Etravirine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Boceprevir Alone		Etravirine Alone		Boceprevir Coadministered With Etravirine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		1/22 (4.5%)		5/25 (20%)
Gastrointestinal disorders
Presumed Viral Illness	0/21 (0%)	0	0/22 (0%)	0	1/25 (4%)	1
Nervous system disorders
Increased energy, anxiety, nervousness, insomnia	0/21 (0%)	0	0/22 (0%)	0	1/25 (4%)	1
Skin and subcutaneous tissue disorders
Rash	0/21 (0%)	0	1/22 (4.5%)	1	3/25 (12%)	3
Other (Not Including Serious) Adverse Events
	Boceprevir Alone		Etravirine Alone		Boceprevir Coadministered With Etravirine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/21 (90.5%)		11/22 (50%)		21/25 (84%)
Gastrointestinal disorders
Altered Taste	18/21 (85.7%)	18	0/22 (0%)	0	16/25 (64%)	16
Nausea	4/21 (19%)	4	3/22 (13.6%)	3	3/25 (12%)	3
General disorders
Headache	4/21 (19%)	4	5/22 (22.7%)	5	4/25 (16%)	4
Fatigue	3/21 (14.3%)	3	1/22 (4.5%)	1	3/25 (12%)	3
Hypokalemia	4/21 (19%)	4	0/22 (0%)	0	2/25 (8%)	2
Skin and subcutaneous tissue disorders
Rash	0/21 (0%)	0	2/22 (9.1%)	2	4/25 (16%)	4

Limitations/Caveats

Healthy volunteer study does not take into account other medications being prescribed to treat the co-infected population. An interaction at the level of enzyme induction is difficult to rule out since we sampled etravirine over 12 hours.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.