Trial Condition(s):
HIV-DDI
Interaction with HIV antiretroviral agents
Bayer Identifier:
17957
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Boston, United States, 02118 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orlando, United States, 32803 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
5
Primary Outcome
- AUC of riociguatTimeframe: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
- Cmax of riociguatTimeframe: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
- AUC of riociguat main metabolite M1 (BAY 60-4552)Timeframe: 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)Timeframe: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Additional Information
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