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Interaction With HIV Antiretroviral Agents

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ClinicalTrials.gov Identifier: NCT02556268
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
HIV-DDI Drug: Riociguat (Adempas, BAY 63-2521) Drug: ATRIPLA Drug: COMPLERA Drug: STRIBILD Drug: TRIUMEQ Drug: Antiretroviral protease inhibitor Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients
Actual Study Start Date : February 23, 2016
Actual Primary Completion Date : December 7, 2016
Actual Study Completion Date : December 7, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Riociguat and ATRIPLA Drug: Riociguat (Adempas, BAY 63-2521)
0.5 mg, Oral (fasted conditions), 1 single dose

Drug: ATRIPLA
600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Experimental: Riociguat and COMPLERA Drug: Riociguat (Adempas, BAY 63-2521)
0.5 mg, Oral (fasted conditions), 1 single dose

Drug: COMPLERA
200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Experimental: Riociguat and STRIBILD Drug: Riociguat (Adempas, BAY 63-2521)
0.5 mg, Oral (fasted conditions), 1 single dose

Drug: STRIBILD
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 Drug: Riociguat (Adempas, BAY 63-2521)
0.5 mg, Oral (fasted conditions), 1 single dose

Drug: TRIUMEQ
600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily

Experimental: Riociguat and antiretroviral protease inhibitor with TRIUMEQ Drug: Riociguat (Adempas, BAY 63-2521)
0.5 mg, Oral (fasted conditions), 1 single dose

Drug: Antiretroviral protease inhibitor
Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents




Primary Outcome Measures :
  1. AUC of riociguat [ Time Frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose ]
  2. Cmax of riociguat [ Time Frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556268


Locations
United States, Florida
Orlando, Florida, United States, 32803
United States, Massachusetts
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02556268     History of Changes
Other Study ID Numbers: 17957
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Single-Dose, Open-Label, Non-Blinded, Non-Placebo-
Controlled, Stratified Design

Additional relevant MeSH terms:
Tenofovir
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine, Rilpivirine, Tenofovir Drug Combination
Anti-Retroviral Agents
Protease Inhibitors
HIV Protease Inhibitors
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents