Trial Condition(s):

HIV-DDI

Interaction with HIV antiretroviral agents

Bayer Identifier:

17957

ClinicalTrials.gov Identifier:

NCT02556268

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
40
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Boston, United States, 02118

Status
Completed
 
Locations

Investigative Site

Orlando, United States, 32803

Status
Completed
 

Trial Design