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

February 23, 2021 updated by: University of Colorado, Denver

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of COlorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1a
Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.
Drug: dolutegravir
dolutegravir tablets 50mg, once daily x 7 days.
Drug: simeprevir
simeprevir tablets 150mg, once daily x 7 days.
Experimental: Sequence 1b
Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.
Drug: dolutegravir
dolutegravir tablets 50mg, once daily x 7 days.
Drug: simeprevir
simeprevir tablets 150mg, once daily x 7 days.
Experimental: Sequence 2a
Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.
Drug: dolutegravir
dolutegravir tablets 50mg, once daily x 7 days.
Drug: simeprevir
simeprevir tablets 150mg, once daily x 7 days.
Experimental: Sequence 2b
Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.
Drug: dolutegravir
dolutegravir tablets 50mg, once daily x 7 days.
Drug: simeprevir
simeprevir tablets 150mg, once daily x 7 days.
Experimental: Sequence 3a
Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.
Drug: dolutegravir
dolutegravir tablets 50mg, once daily x 7 days.
Drug: simeprevir
simeprevir tablets 150mg, once daily x 7 days.
Experimental: Sequence 3b
Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.
Drug: dolutegravir
dolutegravir tablets 50mg, once daily x 7 days.
Drug: simeprevir
simeprevir tablets 150mg, once daily x 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Determine simeprevir area-under-the concentration time curve (AUC) when administered alone and when being co-administered with Dolutegravier.
Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7
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
Determine Dolutegravir area-under-the concentration time curve (AUC) when administered alone and when co-administered with simeprevir.
Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0106
  • 152252 (Other Grant/Funding Number: ViiV Healthcare)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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