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Acquired Immunodeficiency SyndromePhase 2NCT01565850

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

A Phase 2 study testing D/C/F/TAF, DRV and COBI in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 44 sites in 2 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 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
D/C/F/TAF, DRV and COBI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
44 sitesin 2 countries
Study dates
Apr 2012to Feb 2014
Phase
Phase 2
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

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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. Participants 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.

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States43 sites

  • CARE-ID

    Annandale, Virginia, 22003

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AHF Research Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Community Research Initiative (CRI)

    Boston, Massachusetts, 02215

  • ID Consultants, P.A.

    Charlotte, North Carolina, 28209

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of South Carolina School of Medicine Division of Infectious Disease

    Columbia, South Carolina, 29203

  • Southwest Infectious Disease Clinical Research Inc

    Dallas, Texas, 75219

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Apex Research

    Denver, Colorado, 80209

  • Denver Infectious Disease Consultants, PLLC

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Gary J. Richmond,M.D.,P.A.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Gordon E. Crofoot, MD., PA

    Houston, Texas, 77098

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • Anthony Mills MD, Inc

    Los Angeles, California, 90069

  • Mercer University Mercer Medicine

    Macon, Georgia, 31201

  • North Shore University Hospital / Division of Infectious Diseases

    Manhasset, New York, 11030

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Weill Cornell Medical College

    New York, New York, 10011

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • Alta Bates Summit Medical Center, East Bay AIDS Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • IDOCF/ValuhealthMD, LLC

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94304

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Kasier Permanente Medical Center

    San Francisco, California, 94118

  • TPMG--Clinical Trials Unit

    San Francisco, California, 94118

  • Peter Shalit, M.D.

    Seattle, Washington, 98104

  • Central West Clinical Research Inc

    St Louis, Missouri, 63108

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33614

  • Dupont Circle Physician's Group

    Washington D.C., District of Columbia, 20009

  • Whitman-Walker Health

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, PC

    Washington D.C., District of Columbia, 20036

Other trials in United States

Puerto Rico1 site

  • Clinical Research Puerto Rico

    San Juan, 00909

Other trials in Puerto Rico

About this study

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

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.

Being tested
D/C/F/TAF, DRV, COBI, FTC/TDF, D/C/F/TAF Placebo
Keywords
HIV-1, HIV, Treatment-Naive
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.

  • D/C/F/TAFDrug

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

  • DRVDrug

    Also called Prezista®

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

  • COBIDrug

    Also called Tybost®, GS-9350

    COBI 150 mg tablet administered orally once daily

  • FTC/TDFDrug

    Also called Truvada®

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

  • D/C/F/TAF PlaceboDrug

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

  • DRV PlaceboDrug

    DRV placebo tablet administered orally once daily

  • COBI PlaceboDrug

    COBI placebo tablet administered orally once daily

  • FTC/TDF PlaceboDrug

    FTC/TDF placebo tablet administered orally once daily

Study groups in NCT01565850
Study groupRoleWhat they receive
D/C/F/TAFExperimentalD/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo
Receives: Drug: D/C/F/TAF; Drug: DRV Placebo; Drug: COBI Placebo; Drug: FTC/TDF Placebo
DRV+COBI+FTC/TDFActive comparatorDRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo
Receives: Drug: DRV; Drug: COBI; Drug: FTC/TDF; Drug: D/C/F/TAF Placebo

What is being measured

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

  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.

    Measured: Week 24

Secondary outcomes (5)

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

    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.

    Measured: Week 48

  2. Change From Baseline in HIV-1 RNA at Week 24

    Measured: Baseline; Week 24

  3. Change From Baseline in HIV-1 RNA at Week 48

    Measured: Baseline; Week 48

  4. Change From Baseline in CD4+ Cell Count at Week 24

    Measured: Baseline; Week 24

  5. Change From Baseline in CD4+ Cell Count at Week 48

    Measured: Baseline; Week 48

Timeline

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

  1. First posted29 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionJan 2013
  4. Study completionFeb 2014

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01565850
Sponsor's protocol ID
GS-US-299-0102
Status last verified
Mar 2016
First submitted
27 Mar 2012
Last updated
11 Apr 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing D/C/F/TAF, DRV and COBI in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 44 sites in 2 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 16 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 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Apr 2016). 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?

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (time frame: Week 24). 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 NCT01565850.

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 11 Apr 2016.

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