Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT02556268
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02556268
Study Brief:
Protocol Section:
NCT02556268