Interaction With HIV Antiretroviral Agents
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/8/2017 |
| Start Date: | February 23, 2016 |
| End Date: | December 7, 2016 |
Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients
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.
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
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