Interaction With HIV Antiretroviral Agents

Bayer

Status and phase: Completed; Phase 1

Conditions: HIV-DDI

Treatments: Drug: COMPLERA; Drug: ATRIPLA; Drug: Antiretroviral protease inhibitor; Drug: TRIUMEQ; Drug: Riociguat (Adempas, BAY 63-2521); Drug: STRIBILD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02556268

17957

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

Riociguat and ATRIPLA

Experimental group

Treatment:

Drug: Riociguat (Adempas, BAY 63-2521)

Drug: ATRIPLA

Riociguat and COMPLERA

Experimental group

Treatment:

Drug: Riociguat (Adempas, BAY 63-2521)

Drug: COMPLERA

Riociguat and STRIBILD

Experimental group

Treatment:

Drug: STRIBILD

Drug: Riociguat (Adempas, BAY 63-2521)

Riociguat and TRIUMEQ

Experimental group

Treatment:

Drug: TRIUMEQ

Drug: Riociguat (Adempas, BAY 63-2521)

Riociguat and antiretroviral protease inhibitor with TRIUMEQ

Experimental group

Treatment:

Drug: Antiretroviral protease inhibitor

Drug: Riociguat (Adempas, BAY 63-2521)