D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

NCT01565850 | Completed Phase 2 Results DMC

• 1 other identifier: GS-US-299-0102
• Study Type: interventional
• Target: 153
• Locations: 2 countries
• Sites: 44

Brief Summary

This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir 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.

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Keywords

HIV-1; HIV; Treatment-Naive

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24

  The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

  Week 24

Secondary Outcomes (5)

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

  Week 48

• Change From Baseline in HIV-1 RNA at Week 24

  Baseline; Week 24

• Change From Baseline in HIV-1 RNA at Week 48

  Baseline; Week 48

• Change From Baseline in CD4+ Cell Count at Week 24

  Baseline; Week 24

• Change From Baseline in CD4+ Cell Count at Week 48

  Baseline; Week 48

Study Arms (2)

D/C/F/TAF

EXPERIMENTAL

D/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo

Drug: D/C/F/TAF; Drug: DRV Placebo; Drug: COBI Placebo; Drug: FTC/TDF Placebo

DRV+COBI+FTC/TDF

ACTIVE COMPARATOR

DRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo

Drug: DRV; Drug: COBI; Drug: FTC/TDF; Drug: D/C/F/TAF Placebo

Interventions

D/C/F/TAF DRUG

DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily

D/C/F/TAF

DRV DRUG

DRV 800 mg (2 × 400 mg tablets) administered orally once daily

Also known as: Prezista®

DRV+COBI+FTC/TDF

COBI DRUG

COBI 150 mg tablet administered orally once daily

Also known as: Tybost®, GS-9350

DRV+COBI+FTC/TDF

FTC/TDF DRUG

FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily

Also known as: Truvada®

DRV+COBI+FTC/TDF

D/C/F/TAF Placebo DRUG

D/C/F/TAF placebo tablet administered orally once daily

DRV+COBI+FTC/TDF

DRV Placebo DRUG

DRV placebo tablet administered orally once daily

D/C/F/TAF

COBI Placebo DRUG

COBI placebo tablet administered orally once daily

D/C/F/TAF

FTC/TDF Placebo DRUG

FTC/TDF placebo tablet administered orally once daily

D/C/F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-naive: 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (44)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

AHF Research Center

Beverly Hills, California, 90211, United States

Location

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Peter J. Ruane, MD, Inc.

Los Angeles, California, 90036, United States

Location

Anthony Mills MD, Inc

Los Angeles, California, 90069, United States

Location

Orange Coast Medical Group

Newport Beach, California, 92663, United States

Location

Alta Bates Summit Medical Center, East Bay AIDS Center

Oakland, California, 94609, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Kaiser Permanente Medical Group

Sacramento, California, 95825, United States

Location

La Playa Medical Group and Clinical Research

San Diego, California, 92103, United States

Location

Kasier Permanente Medical Center

San Francisco, California, 94118, United States

Location

TPMG--Clinical Trials Unit

San Francisco, California, 94118, United States

Location

Apex Research

Denver, Colorado, 80209, United States

Location

Denver Infectious Disease Consultants, PLLC

Denver, Colorado, 80220, United States

Location

Dupont Circle Physician's Group

Washington D.C., District of Columbia, 20009, United States

Location

Whitman-Walker Health

Washington D.C., District of Columbia, 20009, United States

Location

Capital Medical Associates, PC

Washington D.C., District of Columbia, 20036, United States

Location

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

Fort Lauderdale, Florida, 33316, United States

Location

Wohlfeiler, Piperato and Associates, LLC

Miami Beach, Florida, 33139, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

IDOCF/ValuhealthMD, LLC

Orlando, Florida, 32806, United States

Location

St. Joseph's Comprehensive Research Institute

Tampa, Florida, 33614, United States

Location

Infectious Disease Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Mercer University Mercer Medicine

Macon, Georgia, 31201, United States

Location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Community Research Initiative (CRI)

Boston, Massachusetts, 02215, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Central West Clinical Research Inc

St Louis, Missouri, 63108, United States

Location

North Shore University Hospital / Division of Infectious Diseases

Manhasset, New York, 11030, United States

Location

Weill Cornell Medical College

New York, New York, 10011, United States

Location

ID Consultants, P.A.

Charlotte, North Carolina, 28209, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of South Carolina School of Medicine Division of Infectious Disease

Columbia, South Carolina, 29203, United States

Location

Southwest Infectious Disease Clinical Research Inc

Dallas, Texas, 75219, United States

Location

Tarrant County Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

Therapeutic Concepts, PA

Houston, Texas, 77004, United States

Location

Gordon E. Crofoot, MD., PA

Houston, Texas, 77098, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

CARE-ID

Annandale, Virginia, 22003, United States

Location

Peter Shalit, M.D.

Seattle, Washington, 98104, United States

Location

Clinical Research Puerto Rico

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Darunavir; Cobicistat; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Tenofovir; Organophosphonates; Organophosphorus Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

There were no limitations affecting the analysis or results.

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Moupali Das, MD, MPH

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2014
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-03

Locations

PR (1); US (43)