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HIV-1Phase 3NCT01968551

Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

A Phase 3 study testing E/C/F/TAF, DRV and Baseline DRV- containing ARV regimen in people with HIV-1 and HIV Infections, run by Gilead Sciences at 62 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
E/C/F/TAF, DRV and Baseline DRV- containing ARV regimen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
62 sitesin 2 countries
Study dates
3 Sep 2013to 9 Jul 2016
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

  • Ability to understand and sign a written informed consent form
  • History of at least two prior antiretroviral regimens, and history of resistance to at least two different classes of antiretroviral agents
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening. Virologically suppressed on the current antiretroviral regimen containing darunavir 600 mg twice a day or 800 mg once daily continuously for ≥ 4 months preceding the screening visit and have maintained documented undetectable plasma HIV-1 RNA levels (< 50 copies/mL) and must have documentation of genotype/phenotype prior to current regimen which shows no darunavir associated resistance mutation.
  • Currently receiving raltegravir, elvitegravir, or dolutegravir (50 mg once daily, but not twice daily), or have never received integrase inhibitor, or have documentation of genotype/phenotype within 12 months prior to current regimen which must show no evidence of resistance to integrase inhibitors
  • Normal ECG
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance
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  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
  • Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
  • A female individual is eligible to enter the study if it is confirmed that she is:
  • Not pregnant or nursing
  • Of non-childbearing potential (i.e., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 54 years of age with cessation (for ≥ 12 months) of previously occurring menses), or
  • Of childbearing potential and agrees to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last study drug dose.
  • Female individuals who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
  • Male individuals must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
  • Male individuals must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.

Who cannot join

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria)
  • Hepatitis B surface antigen (HBsAg) positive
  • Individuals receiving drug treatment for Hepatitis C, or individuals who are anticipated to receive treatment for Hepatitis C during the course of the study.
  • Must not have Q151M, T69ins, or > 3 thymidine analogue mutations (TAMS) present on documented historic genotype report
  • Individuals experiencing decompensated cirrhosis
  • Females who are breastfeeding
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  • Positive serum pregnancy test
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use that may interfere with individual's study compliance
  • A 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.
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 visit
  • Any other clinical condition or prior therapy that would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
  • Individuals receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir, cobicistat, emtricitabine, TAF, or DRV; or individuals with any known allergies to the study drugs.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States56 sites

  • Summa Health System CARE Center

    Akron, Ohio, 44304

  • Albany Medical College

    Albany, New York, 12208

  • Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)

    Annandale, Virginia, 220003

  • Atlanta ID Group

    Atlanta, Georgia, 30309

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30312

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Harvard Medical School

    Boston, Massachusetts, 02215

  • Carolinas Medical Center--Myer's Park

    Charlotte, North Carolina, 28207

  • The Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • North Texas infectious Diseases Consultants, PA

    Dallas, Texas, 75246

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Health System

    Durham, North Carolina, 27710

  • New York Hospital Queens

    Flushing, New York, 11355

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Gary J.Richmond, MD, P.A.

    Fort Lauderdale, Florida, 33316

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • East Carolina University The Brody School of Medicine, Infectious Diseases

    Greenville, North Carolina, 27858

  • Kaiser Permanente

    Hayward, California, 94545

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Gordon E. Crofoot MD PA

    Houston, Texas, 77098

  • The Kansas City Free Health Clinic/ KC Care Clinic

    Kansas City, Missouri, 64111

  • Long Beach Education and Research Consultants

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75606

  • Peter J Ruane, MD, Inc.

    Los Angeles, California, 90036

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • Mercer University, Mercer Medicine

    Macon, Georgia, 31201

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55404

  • Beth Israel Medical Center

    New York, New York, 10003

  • Weill Medical College

    New York, New York, 10011

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Valuhealthmd/Idocf

    Orlando, Florida, 32806

  • Infectious Diseases Associates of NW FL

    Pensacola, Florida, 32504

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Pueblo Family Physicians, Ltd.

    Phoenix, Arizona, 85015

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • University of Rochester

    Rochester, New York, 14642

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • University of Utah

    Salt Lake City, Utah, 84102

  • Kaiser San Francisco Division of Research

    San Francisco, California, 94118

  • Southwest CARE Center

    Santa Fe, New Mexico, 87505

  • Peter Shalit, MD

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Baystate Infectious Diseases Clinical Research

    Springfield, Massachusetts, 01199

  • Central West Clinical Research

    St Louis, Missouri, 63108

  • Hillsborough County Health Department

    Tampa, Florida, 33602

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33614

  • AIDS Research and Treatment Center of the Treasure Coast

    Vero Beach, Florida, 32960

  • Dupont Circle Physician's Group

    Washington D.C., District of Columbia, 20009

  • Triple O Research Institute PA

    West Palm Beach, Florida, 33401

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada6 sites

  • Southern Alberta Clinic

    Calgary, Alberta, T2R 0X7

  • Clinique médicale L'actuel

    Montreal, Quebec, H2l 4P9

  • Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Maple Leaf Research

    Toronto, Ontario, M5G1K2

  • Vancouver ID Research & Care Centre Society

    Vancouver, British Columbia, V6Z2C7

  • Wrha - Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

Official title: A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50 copies/mL at Week 24.

This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.

Being tested
E/C/F/TAF, DRV, Baseline DRV- containing ARV regimen
Keywords
HIV-1, HIV, Treatment-Experienced
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

  • E/C/F/TAFDrug

    Also called Genvoya®

    150/150/200/10 mg FDC tablet administered orally once daily

  • DRVDrug

    800 mg tablet administered orally once daily

  • Baseline DRV- containing ARV regimenDrug

    Participants will take their baseline DRV- containing ARV regimen as prescribed.

Study groups in NCT01968551
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants will receive E/C/F/TAF FDC + DRV once daily with food for 48 weeks. Based on safety and efficacy data from Cohort 1 at Week 4, the participants will be randomized into Cohort 2. The participants in Cohort 1 will continue receiving E/C/F/TAF FDC + DRV through 48 weeks.
Receives: Drug: E/C/F/TAF; Drug: DRV
Cohort 2, Treatment Group 1ExperimentalParticipants will be randomized to receive E/C/F/TAF FDC+DRV once daily with food for 48 weeks.
Receives: Drug: E/C/F/TAF; Drug: DRV
Cohort 2, Treatment Group 2Active comparatorParticipants will be randomized to continue on their baseline DRV-containing ARV regimen for 48 weeks.
Receives: Drug: Baseline DRV- containing ARV regimen

What is being measured

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

  1. Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24

    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, 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 (3)

  1. Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48

    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, 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 CD4+ Cell Count at Week 24

    Measured: Baseline; Week 24

  3. 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 posted24 Oct 2013 (estimated)
  2. Study start3 Sep 2013
  3. Primary completion21 Jul 2015
  4. Study completion9 Jul 2016

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01968551
Sponsor's protocol ID
GS-US-292-0119
Status last verified
Jul 2017
First submitted
26 Sep 2013
Last updated
16 Nov 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Publications

  • Huhn GD, Tebas P, Gallant J, Wilkin T, Cheng A, Yan M, Zhong L, Callebaut C, Custodio JM, Fordyce MW, Das M, McCallister S. A Randomized, Open-Label Trial to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Darunavir in Treatment-Experienced HIV-1-Infected Adults. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):193-200. doi: 10.1097/QAI.0000000000001193.

    PubMed 27753684

  • Greg Huhn, Pablo Tebas, Joel Gallant et al. Strategic Simplification: the Efficacy and Safety of Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Plus Darunavir (DRV) in Treatment-Experienced HIV-1-Infected Adults (NCT01968551). IDWeek; 2015 San Diego, CA Oct. 7-11.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E/C/F/TAF, DRV and Baseline DRV- containing ARV regimen in people with HIV-1 and HIV Infections, run by Gilead Sciences at 62 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 17 inclusion and 15 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada. 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 1 Nov 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 in Each Treatment Arm in Cohort 2 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 NCT01968551, 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 16 Nov 2018.

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