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

• ClinicalTrials.gov Identifier: NCT01363011
• Recruitment Status: Completed
• First Posted: June 1, 2011
• Results First Posted: October 31, 2014
• Last Update Posted: May 2, 2016
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Acquired Immunodeficiency Syndrome; HIV Infections	Drug: E/C/F/TDF; Drug: COBI; Drug: ATV; Drug: DRV; Drug: NRTI	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 106 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 2011
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: E/C/F/TDF (Cohort 1); Participants who have not received prior antiretroviral (ARV) treatment and who are virologically unsuppressed at baseline will initiate treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) single-tablet regimen (STR) for up to 96 weeks. Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.	Drug: E/C/F/TDF; E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily; Other Name: Stribild®
Experimental: COBI+PI+2 NRTI (Cohort 2); Participants who have received prior ARV treatment and who are virologically suppressed at baseline will continue their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to cobicistat (COBI), and continuing their existing protease inhibitor (PI; either atazanavir (ATV) or darunavir (DRV)) plus 2 nucleoside reverse transcriptase inhibitor (NRTI) regimen for up to 96 weeks. Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.	Drug: COBI; COBI 150 mg tablet administered with food orally once daily; Other Name: Tybost®; Drug: ATV; ATV 300 mg tablet administered orally once daily; Other Name: Reyataz®; Drug: DRV; DRV 800 mg tablet administered orally once daily; Other Name: Prezista®; 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.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1) [ Time Frame: Baseline; Week 24 ]
   Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).
2. Change From Baseline in eGFR-CG at Week 24 (Cohort 2) [ Time Frame: Baseline; Week 24 ]
   Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).
3. Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1) [ Time Frame: Baseline; Week 24 ]
   Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.
4. Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2) [ Time Frame: Baseline; Week 24 ]
   Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.
5. Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1) [ Time Frame: Baseline; Week 24 ]
   Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.
6. Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2) [ Time Frame: Baseline; Week 24 ]
   Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.
7. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1) [ Time Frame: Baseline; Week 24 ]
   Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.
8. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2) [ Time Frame: Baseline; Week 24 ]
   Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.
9. Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1) [ Time Frame: Baseline; Weeks 2, 4, and 24 ]
   Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance.
10. Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2) [ Time Frame: Baseline; Weeks 2, 4, and 24 ]
    Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance.
11. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 1) [ Time Frame: Week 24 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.
12. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2) [ Time Frame: Week 24 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.

Secondary Outcome Measures :

1. Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1) [ Time Frame: Baseline; Weeks 48 and 96 ]
   Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.
2. Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2) [ Time Frame: Baseline; Week 48 ]
   Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.
3. Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 1) [ Time Frame: Baseline; Weeks 48 and 96 ]
   Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.
4. Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 2) [ Time Frame: Baseline; Weeks 48 and 96 ]
   Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.
5. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 1) [ Time Frame: Baseline; Weeks 48 and 96 ]
   Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.
6. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 2) [ Time Frame: Baseline; Weeks 48 and 96 ]
   Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.
7. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 1) [ Time Frame: Baseline; Weeks 48 and 96 ]
   Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.
8. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 2) [ Time Frame: Baseline; Weeks 48 and 96 ]
   Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.
9. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 1) [ Time Frame: Weeks 48 and 96 ]
   The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.
10. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 2) [ Time Frame: Weeks 48 and 96 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.
11. Percentage of Participants Who Experienced Adverse Events (Cohort 1) [ Time Frame: Up to 147 weeks plus 30 days ]
    Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 1 (treatment-naive). A participant was counted once if they had a qualifying event.
12. Percentage of Participants Who Experienced Adverse Events (Cohort 2) [ Time Frame: Up to 166 weeks plus 30 days ]
    Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 2 (treatment-experienced). A participant was counted once if they had a qualifying event.
13. Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1) [ Time Frame: Up to 147 weeks plus 30 days ]
    Laboratory abnormalities were summarized for Cohort 1 (treatment-naive) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.
14. Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2) [ Time Frame: Up to 166 weeks plus 30 days ]
    Laboratory abnormalities were summarized for Cohort 2 (treatment-experienced) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.
15. Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    AUCtau was analyzed for Cohort 1 (treatment-naive) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
16. Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    AUCtau was analyzed for Cohort 2 (treatment-experienced) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
17. Plasma Pharmacokinetics of COBI: Cmax (Cohort 1) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma.
18. Plasma Pharmacokinetics of COBI: Cmax (Cohort 2) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma.
19. Plasma Pharmacokinetics of COBI: Ctau (Cohort 1) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval.
20. Plasma Pharmacokinetics of COBI: Ctau (Cohort 2) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval.
21. Plasma Pharmacokinetics of COBI: Tmax (Cohort 1) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax.
22. Plasma Pharmacokinetics of COBI: Tmax (Cohort 2) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax.
23. Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug.
24. Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2) [ Time Frame: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24. ]
    t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Cohort 1 (treatment-naive)

• Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
• Screening genotype report must show sensitivity to FTC and TDF
• No prior use of any approved or investigational antiretroviral drug for any length of time

Cohort 2 (treatment-experienced, pharmacoenhancer switch)

• Subjects must be receiving ATV 300 mg/ritonavir (RTV) 100 mg plus 2 NRTIs OR DRV 800 mg/RTV 100 mg plus 2 NRTIs for at least 6 months prior to screening
• Plasma HIV-1 RNA concentrations at undetectable levels in the 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
• Subjects experiencing intolerance to RTV (as determined by the investigator)

Both groups

• The ability to understand and sign a written informed consent form
• Normal ECG
• Mild to moderate renal function
• Stable renal function
• Hepatic transaminases (AST and ALT) ≤ 5 x the upper limit of the normal range (ULN)
• Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (subjects with documented Gilbert's Syndrome or hyperbilirubinemia due to atazanavir therapy may have total bilirubin up to 5 x ULN)
• Adequate hematologic function
• Serum amylase ≤ 5 x ULN
• Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
• Age ≥ 18 years

Exclusion Criteria:

• New AIDS-defining condition diagnosed within the 30 days prior to screening
• Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C
• Subjects experiencing decompensated cirrhosis
• Females who are breastfeeding
• Positive serum pregnancy test (female of childbearing potential)
• Implanted defibrillator or pacemaker
• Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance
• History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
• Receiving ongoing therapy with any of medications contraindicated for use with elvitegravir (EVG), COBI, FTC, TDF, ATV, DRV; or subjects with any known allergies to the excipients of E/C/F/TDF STR, COBI tablets, ATV capsules or DRV tablets or contraindicated for the 2 NRTIs as part of the PI/co regimen
• Participation in any other clinical trial without prior approval
• Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements

Contacts and Locations

Locations

United States, Arizona

Spectrum Medical Group

Phoenix, Arizona, United States, 85012

United States, Arkansas

Health for Life Clinic

Little Rock, Arkansas, United States, 72207

United States, California

AHF Research Center

Beverly Hills, California, United States, 90211

Kaiser Permanente

Los Angeles, California, United States, 90027

Peter J. Ruane, M.D., Inc.

Los Angeles, California, United States, 90036

Anthony Mills, MD, Inc.

Los Angeles, California, United States, 90069

Orange Coast Medical Group

Newport Beach, California, United States, 92663

East Bay AIDS Center

Oakland, California, United States, 94609

University of California, Davis

Sacramento, California, United States, 01105

Metropolis Medical

San Francisco, California, United States, 94115

United States, Colorado

National Jewish Health

Denver, Colorado, United States, 80206

United States, Connecticut

Yale University School of Medicine AIDS Program

New Haven, Connecticut, United States, 06520

United States, District of Columbia

Whitman Walker Clinic

Washington, District of Columbia, United States, 20009

Medical Faculty Associates

Washington, District of Columbia, United States, 20037

United States, Florida

Therafirst Medical Center

Fort Lauderdale, Florida, United States, 33308

Broward Health

Fort Lauderdale, Florida, United States, 33311

Gary J. Richmond.M.D.,P.A.

Fort Lauderdale, Florida, United States, 33316

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

Orlando Immunology Center

Orlando, Florida, United States, 32803

IDOCF/ValueHealthMD, LLC

Orlando, Florida, United States, 32806

United States, Georgia

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States, 30033

Mercer University/ Mercer Medicine Clinical Research

Macon, Georgia, United States, 31201

United States, Illinois

Northstar Medical Center

Chicago, Illinois, United States, 60657

United States, Massachusetts

The Research Institute

Springfield, Massachusetts, United States, 01105

United States, Missouri

Central West Clinical Research, Inc.

St.Louis, Missouri, United States, 63108

United States, New Jersey

ID Care

Hillsborough, New Jersey, United States, 08844

United States, New York

North Shore University Hospital

Manhasset, New York, United States, 11030

Chelsea Village Medical

New York, New York, United States, 10011

Mount Sinai Downtown Comprehensive Health Program

New York, New York, United States, 10011

AIDS Care

Rochester, New York, United States, 14607

United States, North Carolina

Carolinas Medical Center

Charlotte, North Carolina, United States, 28207

United States, Texas

Southwest Infectious Disease Clinical Research, Inc.

Addison, Texas, United States, 75001

Tarrant County Infectious Disease Associates

Fort Worth, Texas, United States, 76104

Therapeutic Concepts, PA

Houston, Texas, United States, 77004

Australia

Taylor Square Private Clinic

Darlinghurst, Australia, 2010

Infectious Diseases Unit - The Alfred Hospital

Melbourne, Australia, 3004

Holdsworth House Medical Practice

Sydney, Australia, 2010

Austria

Landeskrankenhaus Graz West

Graz, Austria, 8020

Otto Wagner Spital

Wien, Austria, 1140

Canada, Ontario

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada, M4N3M5

Canada

Clinique Medicale du Quartier Latin

Montreal, Canada, H2L5B1

Dominican Republic

Instituto Dominicano de Estudio Virologicos

Santo Domingo, Dominican Republic, 99999

Germany

Center for HIV and Hepatogastroenterology

Düsseldorf, Germany, 40237

Mexico

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico, 44280

Puerto Rico

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909

HOPE Clinical Research

San Juan, Puerto Rico, 00909

United Kingdom

Brighton and Sussex University Hospitals NHS Trust

Brighton, United Kingdom, BN2 1ES

Barts & the London NHS Trust

London, United Kingdom, E1 1BB

Homerton University Hospital

London, United Kingdom, SE5 0DJ

Guy's King's and St. Thomas' School of Medicine

London, United Kingdom, SE5 9RJ

St Stephen's AIDS Trust

London, United Kingdom, SW10 9NH

Sponsors and Collaborators

Gilead Sciences

Investigators

• Study Director: Javier Szwarcberg, MD; Gilead Sciences

More Information

Publications of 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.

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.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT01363011
• Other Study ID Numbers: GS-US-236-0118
• First Posted: June 1, 2011
• Results First Posted: October 31, 2014
• Last Update Posted: May 2, 2016
• Last Verified: March 2016

Keywords provided by Gilead Sciences:

HIV-1; Treatment Naive; Treatment Experienced

Additional relevant MeSH terms:

HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immune System Diseases; Slow Virus Diseases; Darunavir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents