Study Completed

HIV-DDI

Bayer Identifier:

17957

ClinicalTrials.gov Identifier:

NCT02556268

EudraCT Number:

Not Available

EU CT Number:

Not Available

Interaction with HIV antiretroviral agents

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

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

Trial Dates

February 2016 - December 2016

Phase

Phase 1

Could I Receive a placebo

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Boston, 02118, United States
Completed		Orlando, 32803, United States

Primary Outcome

AUC of riociguat
Time Frame:
at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Safety Issue:
No
Cmax of riociguat
Time Frame:
at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Safety Issue:
No
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
Safety Issue:
No
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
Safety Issue:
No

Trial design

Potential pharmacokinetic interaction of human immunodeficiency virus (HIV) antiretroviral agents as fixed-dose combinations and riociguat in HIV patients

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Non-randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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