Interaction With HIV Antiretroviral Agents

Phase 1

Completed

• Conditions: HIV-DDI
• Interventions: Drug: Riociguat (Adempas, BAY 63-2521); Drug: TRIUMEQ; Drug: STRIBILD; Drug: Antiretroviral protease inhibitor; Drug: ATRIPLA; Drug: COMPLERA

• Registration Number: NCT02556268
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Study Start: 2016-02-23
• Primary Completion: 2016-12-07
• Study Completion: 2016-12-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Riociguat and STRIBILD	Riociguat (Adempas, BAY 63-2521)	-
Riociguat and TRIUMEQ	Riociguat (Adempas, BAY 63-2521)	-
Riociguat and ATRIPLA	Riociguat (Adempas, BAY 63-2521)	-
Riociguat and TRIUMEQ	TRIUMEQ	-
Riociguat and COMPLERA	Riociguat (Adempas, BAY 63-2521)	-
Riociguat and STRIBILD	STRIBILD	-
Riociguat and antiretroviral protease inhibitor with TRIUMEQ	Riociguat (Adempas, BAY 63-2521)	-
Riociguat and antiretroviral protease inhibitor with TRIUMEQ	Antiretroviral protease inhibitor	-
Riociguat and ATRIPLA	ATRIPLA	-
Riociguat and COMPLERA	COMPLERA	-

Primary Outcome Measures

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