drugset / Trial / NCT01363011

Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

NCT01363011 ↗

Phase 3 Completed 106 enrolled Gilead Sciences
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

Drugs

EvaluationDrugModalityDoseRoute
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 — —

Indications