Expired Study
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Aurora, Colorado 80045


Purpose:

The investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. The investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. Additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.


Study summary:

To investigate the potential for drug interactions between simeprevir and dolutegravir, participants will receive each drug alone and the drugs in combination for 7 days. The pharmacokinetics of simeprevir and dolutegravir when given in combination vs. alone will be compared.


Criteria:

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 investigational drug study within 30 days prior to study entry - 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, ibuprofen, hormonal oral contraceptives - 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.


Study is Available At:


Original ID:

15-0106


NCT ID:

NCT02404805


Secondary ID:

152252


Study Acronym:


Brief Title:

Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers


Official Title:

Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/Hepatitis C Virus (HCV) Seronegative Volunteers


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

6


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jennifer J Kiser, PharmD
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:February 2016
Completion Date:October 2016
Completion Type:Actual
Primary Completion Date:October 2016
Primary Completion Type:Actual
Verification Date:November 2017
Last Changed Date:November 10, 2017
First Received Date:March 18, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Dolutegravir AUC Pharmacokinetics Coadministered With Simeprevir
Time Frame:Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7
Safety Issues:False
Description:Determine dolutegravir AUC when coadministered with simeprevir. [Ratio = dolutegravir administered with simeprevir/dolutegravir alone]
Outcome Type:Primary Outcome
Measure:Simeprevir AUC Pharmacokinetics Coadministered With Dolutegravir
Time Frame:Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7
Safety Issues:False
Description:Determine simeprevir AUC when coadministered with dolutegravir. [Ratio = simeprevir administered with dolutegravir/simeprevir alone]
Outcome Type:Primary Outcome
Measure:Dolutegravir AUC Pharmacokinetics
Time Frame:Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7
Safety Issues:False
Description:Determine dolutegravir area-under-the concentration time curve (AUC) when administered alone.
Outcome Type:Primary Outcome
Measure:Simeprevir AUC Pharmacokinetics
Time Frame:Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7
Safety Issues:False
Description:Determine simeprevir area-under-the concentration time curve (AUC) when administered alone.

Study Interventions

Intervention Type:Drug
Name:dolutegravir
Description:dolutegravir tablets 50mg, once daily x 7 days.
Arm Name:Sequence 1a
Intervention Type:Drug
Name:simeprevir
Description:simeprevir tablets 150mg, once daily x 7 days.
Arm Name:Sequence 1a

Study Arms

Study Arm Type:Experimental
Arm Name:Sequence 3b
Description:Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.
Study Arm Type:Experimental
Arm Name:Sequence 3a
Description:Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.
Study Arm Type:Experimental
Arm Name:Sequence 2b
Description:Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.
Study Arm Type:Experimental
Arm Name:Sequence 2a
Description:Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.
Study Arm Type:Experimental
Arm Name:Sequence 1b
Description:Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.
Study Arm Type:Experimental
Arm Name:Sequence 1a
Description:Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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