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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01440569
Other study ID # GS-US-216-0130
Secondary ID 2011-003501-22
Status Completed
Phase Phase 3
First received September 22, 2011
Last updated November 20, 2015
Start date September 2011
Est. completion date October 2015

Study information

Verified date November 2015
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations.

After the Week 48 Visit, participants will be given the option to participate in an extension period to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.


Recruitment information / eligibility

Status Completed
Enrollment 314
Est. completion date October 2015
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult = 18 years males or non-pregnant females

- Ability to understand and sign a written informed consent form

- General medical condition that does not interfere with the assessments and the completion of the trial

- Treatment Naive: No prior use of any approved or investigational antiretroviral drug for any length of time OR

- Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening

- Plasma HIV-1 RNA levels = 1000 copies/mL at Screening

- Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase inhibitors (NRTIs) and no darunavir resistance-associated mutations

- Normal electrocardiogram (ECG)

- Hepatic transaminases = 2.5 × upper limit of normal (ULN)

- Total bilirubin = 1.5 mg/dL

- Adequate hematologic function

- Serum amylase = 2 × ULN and serum lipase = 3 × ULN

- Adequate renal function: Estimated glomerular filtration rate = 80 mL/min

- Females of childbearing potential must agree to utilize protocol-recommended methods of contraception, or be nonheterosexually active, practice sexual abstinence or have a vasectomized partner from Screening throughout the duration of the study period and for 30 days following the last dose of study drug.

- Male subjects must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse from the Screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or be nonheterosexually active, practice sexual abstinence, or be vasectomized.

Exclusion Criteria:

- Previous or current use of darunavir

- A new AIDS-defining condition diagnosed within the 30 days prior to Screening

- Females who are breastfeeding

- Positive serum pregnancy test (if female of childbearing potential)

- Proven or suspected acute hepatitis in the 30 days prior to study entry

- Subjects receiving drug treatment for hepatitis C virus (HCV), or subjects who are anticipated to receive treatment for HCV during the course of the study

- Have a history of ongoing active liver disease or experiencing decompensated cirrhosis irrespective of liver enzyme levels

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance use that may interfere with subject study compliance

- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma

- Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline

- Participation in any other clinical trial

- Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements.

- Subjects receiving ongoing therapy with any of the medications, including drugs not to be used with cobicistat, darunavir, or investigator selected NRTIs; or subjects with any known allergies to cobicistat tablets, darunavir tablets or contraindications for the 2 NRTIs as part of the regimen.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
COBI
Cobicistat (COBI) 150 mg tablet administered orally with food once daily
DRV
Darunavir (DRV) 800 mg (2 x 400 mg tablets) administered orally with food once daily
NRTIs
Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.

Locations

Country Name City State
Puerto Rico Clinical Research Puerto Rico San Juan
United States Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) Annandale Virginia
United States Atlanta ID group Atlanta Georgia
United States Central Texas Clinical Research Austin Texas
United States Be Well Medical Center Berkley Michigan
United States Community Research Initiative of New England Boston Massachusetts
United States Carolinas Medical Center-Myer's Park Infectious Disease Clinic Charlotte North Carolina
United States Howard Brown Health Center Chicago Illinois
United States Northstar Medical Center Chicago Illinois
United States Southwest Infectious Disease Clinical Research, Inc. Dallas Texas
United States Trinity Health and Wellness Center/AIDS Arms, Inc. Dallas Texas
United States Infectious Disease Specialists of Atlanta Decatur Georgia
United States Apex Research LLC Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Gary J. Richmond,M.D., P.A. Fort Lauderdale Florida
United States Midway Immunology and Research Center Fort Pierce Florida
United States Tarrant County Infectious Disease Fort Worth Texas
United States Hawaii Center for AIDS, University of Hawaii Honolulu Hawaii
United States Gordon Crofoot MD, PA Houston Texas
United States Gordon E. Crofoot MD PA Houston Texas
United States Therapeutic Concepts, PA Houston Texas
United States Long Beach Education and Research Consultants, PC Long Beach California
United States DCOL Center for Clinical Research Longview Texas
United States Anthony Mills MD Inc Los Angeles California
United States Peter J Ruane MD Inc. Los Angeles California
United States Johns Hopkins University Lutherville Maryland
United States Mercer University Macon Georgia
United States North Shore University Hospital / Division of Infectious Diseases Manhasset New York
United States Wohlfeiler, Piperato and Associates, LLC Miami Beach Florida
United States HIV Program Hennepin County Medical Center Minneapolis Minnesota
United States Greiger Clinic Mt. Vernon New York
United States Beth Israel Medical Center New York New York
United States Saint Michael's Medical Center Newark New Jersey
United States Orlando Immunology Center Orlando Florida
United States Stanford University Palo Alto California
United States Philadelphia FIGHT Philadelphia Pennsylvania
United States University of PA Philadelphia Pennsylvania
United States Spectrum Medical Group Phoenix Arizona
United States Miriam Hospital Providence Rhode Island
United States Kaiser Permanente Medical Group Sacramento California
United States La Playa Medical Group and Clinical Research San Diego California
United States Metropolis Medical San Francisco California
United States Swedish Medical Center Seattle Washington
United States South Jersey Infectious Disease Somers Point New Jersey
United States Central West Clinical Research Inc St. Louis Michigan
United States St. Joseph's Comprehensive Research Institute Tampa Florida
United States Dupont Circle Physician's Group Washington District of Columbia
United States Whitman-Walker Health Washington District of Columbia
United States Wake Forest University Health Services Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Gilead Sciences Janssen, LP

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24 Up to 24 weeks No
Secondary Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis) Week 24 No
Secondary Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis) Week 48 No
Secondary Change From Baseline in CD4+ Cell Count at Week 24 Baseline; Week 24 No
Secondary Change From Baseline in CD4+ Cell Count at Week 48 Baseline; Week 48 No
Secondary Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24 Up to 24 weeks No
Secondary Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48 Up to 48 weeks No
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