drugset / Trial / NCT02556268

Interaction With HIV Antiretroviral Agents

NCT02556268 ↗

Phase 1 Completed 40 enrolled Bayer
Non-randomizedParallel-groupOpen-labelOther

Summary

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.

Timeline

Start
2016-02-23
Primary completion
2016-12-07
Completion
2016-12-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Riociguat Other / unclassified 0.5 mg Oral
Background Abacavir Other / unclassified 600 mg —
Background Atazanavir Other / unclassified — —
Background Cobicistat Small molecule 150 mg —
Background Darunavir Small molecule — —
Background Dolutegravir Other / unclassified 50 mg —
Background Efavirenz Other / unclassified 600 mg —
Background INDINAVIR ANHYDROUS Other / unclassified — —
Background Lamivudine Other / unclassified 300 mg —
Background Rilpivirine Small molecule 25 mg —
Background Ritonavir Other / unclassified — —
Background Saquinavir Small molecule — —
Background Tenofovir disoproxil fumarate Small molecule 300 mg —
Background elvitegravir Small molecule 150 mg —
Background emtricitabine Other / unclassified 200 mg —

Indications

No indication recorded.