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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of Colorado, Denver


Information provided by (Responsible Party)
University of Colorado, Denver
ClinicalTrials.gov Identifier
NCT02404805

First received: March 18, 2015
Last updated: November 21, 2016
Last Verified: November 2016
History of Changes
Purpose

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.

Condition Intervention
HIV
Hepatitis C

Drug : dolutegravir
Drug : simeprevir

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/Hepatitis C Virus (HCV) Seronegative Volunteers

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures

  • 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.
  • 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.
  • 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 ]
    Determine simeprevir AUC when coadministered with dolutegravir. [Ratio = simeprevir administered with dolutegravir/simeprevir alone]
  • 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 ]
    Determine dolutegravir AUC when coadministered with simeprevir. [Ratio = dolutegravir administered with simeprevir/dolutegravir alone]

Enrollment: 25
Study Start Date: February 2016
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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.

Eligibility

Eligibility

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

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02404805

Locations

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

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Jennifer J Kiser, PharmD University of Colorado, Denver
More Information

More Information


Responsible Party: University of Colorado, Denver  
ClinicalTrials.gov Identifier: NCT02404805   History of Changes  
Other Study ID Numbers: 15-0106  
  152252  
Study First Received: March 18, 2015  
Last Updated: November 21, 2016  

Keywords provided by University of Colorado, Denver:

dolutegravir
simeprevir
HIV
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Dolutegravir
Simeprevir

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.