- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02556268
Interaction With HIV Antiretroviral Agents
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
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
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Orlando, Florida, United States, 32803
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Massachusetts
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Boston, Massachusetts, United States, 02118
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Viral Protease Inhibitors
- Enzyme Activators
- Protease Inhibitors
- Anti-Retroviral Agents
- Riociguat
- Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
- HIV Protease Inhibitors
- Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
- Emtricitabine, Rilpivirine, Tenofovir Drug Combination
- Triumeq
Other Study ID Numbers
- 17957
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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