HIVNCT02404805

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

A study testing dolutegravir and simeprevir in people with HIV and Hepatitis C, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: HIV, Hepatitis C
What is being tested?: dolutegravir and simeprevir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Feb 2016to Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

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

Read the 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.

Conditions: HIV, Hepatitis C
Being tested: dolutegravir, simeprevir
Keywords: dolutegravir, simeprevir, HIV, HCV
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dolutegravirDrug
dolutegravir tablets 50mg, once daily x 7 days.
simeprevirDrug
simeprevir tablets 150mg, once daily x 7 days.

Study groups in NCT02404805
Study group	Role	What they receive
Sequence 1a	Experimental	Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir. Receives: Drug: dolutegravir; Drug: simeprevir
Sequence 1b	Experimental	Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only. Receives: Drug: dolutegravir; Drug: simeprevir
Sequence 2a	Experimental	Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir. Receives: Drug: dolutegravir; Drug: simeprevir
Sequence 2b	Experimental	Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only. Receives: Drug: dolutegravir; Drug: simeprevir
Sequence 3a	Experimental	Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only. Receives: Drug: dolutegravir; Drug: simeprevir
Sequence 3b	Experimental	Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only. Receives: Drug: dolutegravir; Drug: simeprevir

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Oct 2016

First posted1 Apr 2015 (estimated)
Study startFeb 2016
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02404805
Sponsor's protocol ID: 15-0106
Other IDs: 152252
Status last verified: Feb 2021
First submitted: 18 Mar 2015
Last updated: 17 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

MacBrayne CE, Castillo-Mancilla J, Burton JR Jr, MaWhinney S, Wagner CB, Micke K, Fey J, Huntley RT, Larson B, Bushman LR, Kiser JJ. Small increase in dolutegravir trough, but equivalent total dolutegravir exposure with simeprevir in HIV/HCV seronegative volunteers. J Antimicrob Chemother. 2018 Jan 1;73(1):156-159. doi: 10.1093/jac/dkx344.
PubMed 29029135

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/Hepatitis C Virus (HCV) Seronegative Volunteers
ClinicalTrials.gov ID: NCT02404805
Acronym / sponsor ID: 15-0106
Conditions: HIV, Hepatitis C
Keywords: dolutegravir, simeprevir, HIV, HCV
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: Feb 2016
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 1 Apr 2015 (estimated)
Results: Posted 17 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1a	Experimental	Drug: dolutegravir, Drug: simeprevirSequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.
Sequence 1b	Experimental	Drug: dolutegravir, Drug: simeprevirSequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.
Sequence 2a	Experimental	Drug: dolutegravir, Drug: simeprevirSequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.
Sequence 2b	Experimental	Drug: dolutegravir, Drug: simeprevirSequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.
Sequence 3a	Experimental	Drug: dolutegravir, Drug: simeprevirSequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.
Sequence 3b	Experimental	Drug: dolutegravir, Drug: simeprevirSequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dolutegravirdolutegravir tablets 50mg, once daily x 7 days.	Drug	Sequence 1a, Sequence 1b, Sequence 2a, Sequence 2b, Sequence 3a, Sequence 3b
simeprevirsimeprevir tablets 150mg, once daily x 7 days.	Drug	Sequence 1a, Sequence 1b, Sequence 2a, Sequence 2b, Sequence 3a, Sequence 3b

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 17 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1a	5	4
Sequence 1b	3	3
Sequence 2a	5	5
Sequence 2b	5	5
Sequence 3a	3	3
Sequence 3b	4	4

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Simeprevir Administered Alone n = 24	Simeprevir and Dolutegravier Co-administered n = 24
Value	30946 (80)	30333 (82)

Population analysed: Only arms that included Simeprevir administration are included.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Dolutegravir Administered Alone n = 24	Simeprevir and Dolutegravier Co-administered n = 24
Value	68186 (30)	78433 (24)

Population analysed: Only arms that included Dolutegravir administration are included.

Adverse events

Time frame: Time of consenting to study exit (Phone follow up 7 days after final intensive PK visit, max 3 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simeprevir Only	0 of 25 (0%)	4 of 25 (16%)	0 of 25
Dolutegravir Only	0 of 24 (0%)	7 of 24 (29.2%)	0 of 24
Dolutegravir and Simeprevir Co-administered:	0 of 24 (0%)	10 of 24 (41.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29029135MacBrayne CE, Castillo-Mancilla J, Burton JR Jr, MaWhinney S, Wagner CB, Micke K, Fey J, Huntley RT, Larson B, Bushman LR, Kiser JJ. Small increase in dolutegravir trough, but equivalent total dolutegravir exposure with simeprevir in HIV/HCV seronegative volunteers. J Antimicrob Chemother. 2018 Jan 1;73(1):156-159. doi: 10.1093/jac/dkx344.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer J Kiser, PharmD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing dolutegravir and simeprevir in people with HIV and Hepatitis C, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02404805, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.