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.