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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat and ATRIPLA | Experimental |
| |
| Riociguat and COMPLERA | Experimental |
| |
| Riociguat and STRIBILD | Experimental |
| |
| Riociguat and TRIUMEQ | Experimental |
| |
| Riociguat and antiretroviral protease inhibitor with TRIUMEQ | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY 63-2521) | Drug | 0.5 mg, Oral (fasted conditions), 1 single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of riociguat | at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose | |
| Cmax of riociguat | at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose | |
| AUC of riociguat main metabolite M1 (BAY 60-4552) | at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose | |
| Cmax of riociguat main metabolite M1 (BAY 60-4552) | at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando | Florida | 32803 | United States | |||
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| ID | Term |
|---|---|
| C542595 | riociguat |
| D000068257 | Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068678 | Emtricitabine, Rilpivirine, Tenofovir Drug Combination |
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C000631408 | abacavir, dolutegravir, and lamivudine drug combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| ATRIPLA | Drug | 600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily |
|
| COMPLERA | Drug | 200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily |
|
| STRIBILD | Drug | 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily |
|
| TRIUMEQ | Drug | 600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily |
|
| Antiretroviral protease inhibitor | Drug | Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents |
|
| Boston |
| Massachusetts |
| 02118 |
| United States |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000068696 | Rilpivirine |
| D009570 | Nitriles |
| D000069547 | Cobicistat |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |