drugset / Trial / NCT01363011
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.
Timeline
- Start
- 2011-05
- Primary completion
- 2013-01
- Completion
- 2015-02
Publications
- Results Fisher M, McDonald C, Moyle G, Martorell C, Ramgopal M, Laplante F, Curley J, Graham H, Tran-Muchowski C, Liu Y, Rhee M, Szwarcberg J. Switching from ritonavir to cobicistat in HIV patients with renal impairment who are virologically suppressed on a protease inhibitor. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19824. doi: 10.7448/IAS.17.4.19824. eCollection 2014.
- Results Post FA, Winston J, Andrade-Villanueva JF, Fisher M, Liu Y, Beraud C, Abram ME, Graham H, Rhee MS, Cheng AK, Szwarcberg J; Study 118 Team. Elvitegravir/cobicistat/emtricitabine/tenofovir DF in HIV-infected patients with mild-to-moderate renal impairment. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):310-3. doi: 10.1097/QAI.0000000000000476.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cobicistat | Small molecule | 150 mg | Oral |
| Subject | E/C/F/TDF | Unknown | — | Oral |
| Background | Abacavir | Other / unclassified | — | — |
| Background | Atazanavir | Other / unclassified | 300 mg | Oral |
| Background | Darunavir | Small molecule | 800 mg | Oral |
| Background | Didanosine | Small molecule | — | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Background | Zidovudine | Small molecule | — | — |
| Background | emtricitabine | Other / unclassified | — | — |