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AzTrials

Acquired Immunodeficiency SyndromePhase 3NCT01363011

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

A Phase 3 study testing E/C/F/TDF, COBI and ATV in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 51 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
E/C/F/TDF, COBI and ATV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
51 sitesin 9 countries
Study dates
May 2011to Feb 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

51 sites in 9 countries.

51 sites in 9 countries

United States34 sites

  • Southwest Infectious Disease Clinical Research, Inc.

    Addison, Texas, 75001

  • AHF Research Center

    Beverly Hills, California, 90211

  • Carolinas Medical Center

    Charlotte, North Carolina, 28207

  • Northstar Medical Center

    Chicago, Illinois, 60657

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • National Jewish Health

    Denver, Colorado, 80206

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Broward Health

    Fort Lauderdale, Florida, 33311

  • Gary J. Richmond.M.D.,P.A.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • ID Care

    Hillsborough, New Jersey, 08844

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Health for Life Clinic

    Little Rock, Arkansas, 72207

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Peter J. Ruane, M.D., Inc.

    Los Angeles, California, 90036

  • Anthony Mills, MD, Inc.

    Los Angeles, California, 90069

  • Mercer University/ Mercer Medicine Clinical Research

    Macon, Georgia, 31201

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Yale University School of Medicine AIDS Program

    New Haven, Connecticut, 06520

  • Chelsea Village Medical

    New York, New York, 10011

  • Mount Sinai Downtown Comprehensive Health Program

    New York, New York, 10011

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • East Bay AIDS Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • IDOCF/ValueHealthMD, LLC

    Orlando, Florida, 32806

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • AIDS Care

    Rochester, New York, 14607

  • University of California, Davis

    Sacramento, California, 01105

  • Metropolis Medical

    San Francisco, California, 94115

  • The Research Institute

    Springfield, Massachusetts, 01105

  • Central West Clinical Research, Inc.

    St Louis, Missouri, 63108

  • Whitman Walker Clinic

    Washington D.C., District of Columbia, 20009

  • Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

United Kingdom5 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 1ES

  • Barts & the London NHS Trust

    London, E1 1BB

  • Homerton University Hospital

    London, SE5 0DJ

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

    London, SE5 9RJ

  • St Stephen's AIDS Trust

    London, SW10 9NH

Other trials in United Kingdom

Australia3 sites

  • Taylor Square Private Clinic

    Darlinghurst, 2010

  • Infectious Diseases Unit - The Alfred Hospital

    Melbourne, 3004

  • Holdsworth House Medical Practice

    Sydney, 2010

Other trials in Australia

Austria2 sites

  • Landeskrankenhaus Graz West

    Graz, 8020

  • Otto Wagner Spital

    Vienna, 1140

Other trials in Austria

Canada2 sites

  • Clinique Medicale du Quartier Latin

    Montreal, H2L5B1

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N3M5

Other trials in Canada

Puerto Rico2 sites

  • Clinical Research Puerto Rico

    San Juan, 00909

  • HOPE Clinical Research

    San Juan, 00909

Other trials in Puerto Rico

Dominican Republic1 site

  • Instituto Dominicano de Estudio Virologicos

    Santo Domingo, 99999

Other trials in Dominican Republic

Germany1 site

  • Center for HIV and Hepatogastroenterology

    Düsseldorf, 40237

Other trials in Germany

Mexico1 site

  • Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, 44280

Other trials in Mexico

About this study

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

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.

Being tested
E/C/F/TDF, COBI, ATV, DRV, NRTI
Keywords
HIV-1, Treatment Naive, Treatment Experienced
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E/C/F/TDFDrug

    Also called Stribild®

    E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily

  • COBIDrug

    Also called Tybost®

    COBI 150 mg tablet administered with food orally once daily

  • ATVDrug

    Also called Reyataz®

    ATV 300 mg tablet administered orally once daily

  • DRVDrug

    Also called Prezista®

    DRV 800 mg tablet administered orally once daily

  • NRTIDrug

    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.

Study groups in NCT01363011
Study groupRoleWhat they receive
E/C/F/TDF (Cohort 1)ExperimentalParticipants 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.
Receives: Drug: E/C/F/TDF
COBI+PI+2 NRTI (Cohort 2)ExperimentalParticipants 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.
Receives: Drug: COBI; Drug: ATV; Drug: DRV; Drug: NRTI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)

    Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).

    Measured: Baseline; Week 24

  2. Change From Baseline in eGFR-CG at Week 24 (Cohort 2)

    Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).

    Measured: Baseline; Week 24

  3. Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)

    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.

    Measured: Baseline; Week 24

  4. Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)

    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.

    Measured: Baseline; Week 24

  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)

    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.

    Measured: Baseline; Week 24

  6. Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)

    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.

    Measured: Baseline; Week 24

  7. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1)

    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.

    Measured: Baseline; Week 24

  8. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2)

    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.

    Measured: Baseline; Week 24

  9. Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1)

    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.

    Measured: Baseline; Weeks 2, 4, and 24

  10. Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2)

    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.

    Measured: Baseline; Weeks 2, 4, and 24

  11. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 1)

    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.

    Measured: Week 24

  12. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2)

    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.

    Measured: Week 24

Secondary outcomes (24)

  1. Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1)

    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.

    Measured: Baseline; Weeks 48 and 96

  2. Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2)

    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.

    Measured: Baseline; Week 48

  3. Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 1)

    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.

    Measured: Baseline; Weeks 48 and 96

  4. Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 2)

    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.

    Measured: Baseline; Weeks 48 and 96

  5. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 1)

    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.

    Measured: Baseline; Weeks 48 and 96

  6. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 2)

    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.

    Measured: Baseline; Weeks 48 and 96

  7. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 1)

    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.

    Measured: Baseline; Weeks 48 and 96

  8. Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 2)

    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.

    Measured: Baseline; Weeks 48 and 96

  9. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 1)

    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.

    Measured: Weeks 48 and 96

  10. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 2)

    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.

    Measured: Weeks 48 and 96

  11. Percentage of Participants Who Experienced Adverse Events (Cohort 1)

    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.

    Measured: Up to 147 weeks plus 30 days

  12. Percentage of Participants Who Experienced Adverse Events (Cohort 2)

    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.

    Measured: Up to 166 weeks plus 30 days

  13. Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1)

    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.

    Measured: Up to 147 weeks plus 30 days

  14. Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2)

    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.

    Measured: Up to 166 weeks plus 30 days

  15. Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1)

    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).

    Measured: 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.

  16. Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2)

    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).

    Measured: 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.

  17. Plasma Pharmacokinetics of COBI: Cmax (Cohort 1)

    Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma.

    Measured: 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.

  18. Plasma Pharmacokinetics of COBI: Cmax (Cohort 2)

    Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma.

    Measured: 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.

  19. Plasma Pharmacokinetics of COBI: Ctau (Cohort 1)

    Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval.

    Measured: 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.

  20. Plasma Pharmacokinetics of COBI: Ctau (Cohort 2)

    Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval.

    Measured: 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.

  21. Plasma Pharmacokinetics of COBI: Tmax (Cohort 1)

    Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax.

    Measured: 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.

  22. Plasma Pharmacokinetics of COBI: Tmax (Cohort 2)

    Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax.

    Measured: 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.

  23. Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1)

    t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug.

    Measured: 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.

  24. Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2)

    t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2013
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01363011
Sponsor's protocol ID
GS-US-236-0118
Status last verified
Mar 2016
First submitted
11 May 2011
Last updated
2 May 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 25397568

  • 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.

    PubMed 25469527

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E/C/F/TDF, COBI and ATV in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 51 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, United Kingdom, Australia, Austria, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01363011, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.

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