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

NCT01363011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2016-05-02

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Javier Szwarcberg, MD · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-01-31
Completion
2015-02-28

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Dominican Republic
  • Germany
  • Mexico
  • Puerto Rico
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01363011 on ClinicalTrials.gov