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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404805
• Other study ID #: 15-0106
• Secondary ID: 152252
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: February 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• HIV

Intervention

Drug:
• dolutegravir
dolutegravir tablets 50mg, once daily x 7 days.
• simeprevir
simeprevir tablets 150mg, once daily x 7 days.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simeprevir AUC Pharmacokinetics	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
Primary	Dolutegravir AUC Pharmacokinetics	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