NCT01363011

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

A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Immunodeficiency Syndrome
• HIV Infections

Interventions

Type	Name	Description
DRUG	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily
DRUG	COBI	COBI 150 mg tablet administered with food orally once daily
DRUG	ATV	ATV 300 mg tablet administered orally once daily
DRUG	DRV	DRV 800 mg tablet administered orally once daily
DRUG	NRTI	Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-01-01
• Completion: 2015-02-01
• First posted: 2011-06-01
• Last updated: 2016-05-02
• Results posted: 2014-10-31

Locations

51 sites across 9 countries: United States, Australia, Austria, Canada, Dominican Republic, Germany, Mexico, Puerto Rico, United Kingdom