Interaction With HIV Antiretroviral Agents

December 5, 2017 updated by: Bayer

Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients

To investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these therapies.

• To Assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

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

    • Florida
      • Orlando, Florida, United States, 32803
    • Massachusetts
      • Boston, Massachusetts, United States, 02118

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients aged >=18 to <65 years with a confirmed diagnosis of HIV receiving a stable regimen of ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) TRIUMEQ consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat
  • No clinical evidence of pulmonary hypertension
  • Written informed consent

Exclusion Criteria:

  • Severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal
  • History of coronary artery disease
  • Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
  • History of bronchial asthma or any other airway disease
  • Renal impairment with creatinine clearance <15 mL/min
  • Severe hepatic impairment (Child-Pugh class C)
  • Systolic blood pressure below 100 mmHg

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Riociguat and ATRIPLA
0.5 mg, Oral (fasted conditions), 1 single dose
600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
Experimental: Riociguat and COMPLERA
0.5 mg, Oral (fasted conditions), 1 single dose
200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
Experimental: Riociguat and STRIBILD
0.5 mg, Oral (fasted conditions), 1 single dose
150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
Experimental: Riociguat and TRIUMEQ
0.5 mg, Oral (fasted conditions), 1 single dose
600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily
Experimental: Riociguat and antiretroviral protease inhibitor with TRIUMEQ
0.5 mg, Oral (fasted conditions), 1 single dose
Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC of riociguat
Time Frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Cmax of riociguat
Time Frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
AUC of riociguat main metabolite M1 (BAY 60-4552)
Time Frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Cmax of riociguat main metabolite M1 (BAY 60-4552)
Time Frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose

Collaborators and Investigators

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

Sponsor

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 (Actual)

February 23, 2016

Primary Completion (Actual)

December 7, 2016

Study Completion (Actual)

December 7, 2016

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

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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