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Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acquired Immunodeficiency Syndrome; HIV Infections

Intervention: D/C/F/TAF (Drug); DRV (Drug); COBI (Drug); FTC/TDF (Drug); Placebo to match D/C/F/TAF (Drug); Placebo to match DRV (Drug); Placebo to match COBI (Drug); Placebo to match FTC/TDF (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Huyen Cao, MD, Study Director, Affiliation: Gilead Sciences

Summary

This study is to evaluate the efficacy darunavir/cobicistat/emtricitabine/GS-7340 (D/C/F/TAF) single-tablet regimen (STR) versus darunavir (DRV)+cobicistat (COBI)+emtricitabine(FTC)/tenofuvir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.

Clinical Details

Official title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24

Secondary outcome:

Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48

Change from baseline in log10 HIV-1 RNA and in CD4+ cell count at Weeks 24 and 48

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult (≥ 18 years) males or non-pregnant females

- Ability to understand and sign a written informed consent form

- General medical condition which does not interfere with the assessments and the

completion of the trial

- Plasma HIV-1 RNA levels ≥ 5,000 copies/mL

- CD4+ cell count > 50 cells/µL

- Treatment Naïve: No prior use of any approved or experimental anti-HIV drug for any

length of time

- Screening genotype report must show sensitivity to DRV, TDF and FTC

- Normal ECG

- Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according

to the Cockcroft Gault formula

- Hepatic transaminases ≤ 2. 5 x upper limit of normal (ULN)

- Total bilirubin ≤ 1. 5 mg/dL

- Serum amylase ≤ 5 x ULN

- Adequate hematologic function

- Normal thyroid-stimulating hormone (TSH)

- Females of childbearing potential must have a negative serum pregnancy test

- 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 drugs

- Female subjects who are postmenopausal must have documentation of cessation of menses

for ≥ 12 months and hormonal failure

- Female subjects who have stopped menstruating for ≥ 12 months but do not have

documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level test

- Male subjects must agree to utilize a highly effective method of contraception during

heterosexual intercourse throughout the study period and for 90 days following discontinuation of investigational medicinal product Exclusion Criteria:

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

- Hepatitis B surface Antigen positive

- Hepatitis C Antibody positive

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

- Have a history or experiencing decompensated cirrhosis

- Current alcohol or substance use that potentially interferes with study compliance

- Any other clinical condition or prior therapy that would make the subject unsuitable

for the study or unable to comply with the dosing requirements

- History of malignancy within the past 5 years or ongoing malignancy other than

cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Female subjects who utilize non-estrogen hormonal contraceptive as one of their birth

control methods must have used the same method for at least three months prior to study dosing

- Have an implanted defibrillator or pacemaker

- Active, serious infections (other than HIV-1 infection) requiring parenteral

antibiotic or antifungal therapy within 30 days prior to Baseline

- Participation in any other clinical trial without prior approval is prohibited while

participating in this trial

- Receiving ongoing therapy with any of the disallowed medications, including drugs not

to be used with darunavir and cobicistat

- Note: Darunavir is a sulfonamide. Subjects who previously experienced a sulfonamide

allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and darunavir has been identified in patients participating in Phase 2 and Phase 3 trials.

Locations and Contacts

Clinical Research Puerto Rico, San Juan 00909, Puerto Rico

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

AHF Research Center, Beverly Hills, California 90211, United States

Anthony Mills MD, Inc, Los Angeles, California 90069, United States

Kaiser Permanente, Los Angeles, California 90027, United States

Peter J. Ruane, MD, Inc., Los Angeles, California 90036, United States

Orange Coast Medical Group, Newport Beach, California 92663, United States

Alta Bates Summit Medical Center, East Bay AIDS Center, Oakland, California 94609, United States

Stanford University, Palo Alto, California 94304, United States

Kaiser Permanente Medical Group, Sacramento, California 95825, United States

La Playa Medical Group and Clinical Research, San Diego, California 92103, United States

TPMG--Clinical Trials Unit, San Francisco, California 94118, United States

Denver Infectious Disease Consultants, PLLC, Denver, Colorado 80220, United States

Capital Medical Associates, PC, Washington, District of Columbia 20036, United States

Dupont Circle Physician's Group, Washington, District of Columbia 20009, United States

Whitman-Walker Health, Washington, District of Columbia 20009, United States

Gary J. Richmond,M.D.,P.A., Fort Lauderdale, Florida 33316, United States

Wohlfeiler, Piperato and Associates, LLC, Miami Beach, Florida 33139, United States

IDOCF/ValuhealthMD, LLC, Orlando, Florida 32806, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

St. Joseph's Comprehensive Research Institute, Tampa, Florida 33614, United States

Infectious Disease Specialists of Atlanta, Decatur, Georgia 30033, United States

Mercer University Mercer Medicine, Macon, Georgia 31201, United States

Howard Brown Health Center, Chicago, Illinois 60613, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Community Research Initiative (CRI), Boston, Massachusetts 02215, United States

Be Well Medical Center, Berkley, Michigan 48072, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States

Central West Clinical Research Inc, St. Louis, Missouri 63108, United States

North Shore University Hospital / Division of Infectious Diseases, Manhasset, New York 11030, United States

Weill Cornell Medical College, New York, New York 10011, United States

ID Consultants, P.A., Charlotte, North Carolina 28209, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

University of South Carolina School of Medicine Division of Infectious Disease, Columbia, South Carolina 29203, United States

Southwest Infectious Disease Clinical Research Inc, Dallas, Texas 75219, United States

Tarrant County Infectious Disease Associates, Fort Worth, Texas 76104, United States

Gordon E. Crofoot, MD., PA, Houston, Texas 77098, United States

Therapeutic Concepts, PA, Houston, Texas 77004, United States

DCOL Center for Clinical Research, Longview, Texas 75605, United States

CARE-ID, Annandale, Virginia 22003, United States

Peter Shalit, M.D., Seattle, Washington 98104, United States

Additional Information

Starting date: April 2012
Last updated: February 27, 2014

Page last updated: August 23, 2015

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