Interaction With HIV Antiretroviral Agents
Completed · Phase 1
Conditions studied: HIV-DDI
In brief
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 facts
- Study ID
- NCT02556268
- Run by
- Bayer
- People needed
- 40
- Starts
- 2016-02-23
- Expected to finish
- 2016-12-07
- Last updated by the study team
- 2017-12-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Orlando, Florida, United States
- Study site — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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