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Acquired Immunodeficiency SyndromePhase 2NCT01497899

Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

A Phase 2 study testing E/C/F/TDF and E/C/F/TAF in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 41 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 (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
E/C/F/TDF and E/C/F/TAF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
279 participants
Where
41 sitesin 2 countries
Study dates
28 Dec 2011to 22 Aug 2016
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

  • Ability to understand and sign a written informed consent form
  • Plasma HIV 1 RNA levels ≥ 5,000 copies/mL
  • No prior use of any approved or experimental anti-HIV drug for any length of time
  • Screening genotype report must show sensitivity to TDF and emtricitabine (FTC)
  • Normal ECG
  • Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
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  • Hepatic transaminases ≤ 2.5 x upper limit of the normal range (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • CD4+ cell count > 50 cells/µL
  • Serum amylase ≤ 5 x ULN
  • 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 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
  • 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 at screening
  • 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
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Who cannot join

  • 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
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
Show all 18Show fewer
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir and cobicistat
  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
  • Current alcohol or substance
  • History of or ongoing malignancy (including untreated carcinoma in-situ) 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 Baseline
  • Participation in any other clinical trial without prior approval is prohibited while participating in this trial
  • Medications contraindicated for use with emtricitabine or tenofovir disoproxil fumarate
  • Any known allergies to the excipients of E/C/F/TAF or E/C/F/TDF FDC tablets
  • Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

41 sites in 2 countries.

41 sites in 2 countries

United States40 sites

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AHF Research Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35233

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • 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, LLC

    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

  • East Bay AIDS Center

    Oakland, California, 94609

  • St. Joseph Heritage Healthcare

    Orange, California, 92869

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • IDOCF/ValuhealthMD, LLC

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94304

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Metropolis Medical

    San Francisco, California, 94107

  • Kaiser Permanente Medical Group-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 Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Being tested
E/C/F/TDF, E/C/F/TAF Placebo, E/C/F/TAF, E/C/F/TDF 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.

  • E/C/F/TDFDrug

    Also called Stribild®

    150/150/200/300 mg FDC tablet administered orally once daily

  • E/C/F/TAF PlaceboDrug

    Tablet administered orally once daily

  • E/C/F/TAFDrug

    Also called Genvoya®

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

  • E/C/F/TDF PlaceboDrug

    Tablet administered orally once daily

Study groups in NCT01497899
Study groupRoleWhat they receive
E/C/F/TAFExperimentalE/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks
Receives: Drug: E/C/F/TAF; Drug: E/C/F/TDF Placebo
E/C/F/TDFActive comparatorE/C/F/TDF plus E/C/F/TAF placebo for at least 48 weeks
Receives: Drug: E/C/F/TDF; Drug: E/C/F/TAF Placebo
E/C/F/TAF Open-LabelExperimentalFollowing study unblinding, participants from the E/C/F/TAF and E/C/F/TDF arms may have the option to receive E/C/F/TAF during an open-label extension phase. Also, participants who are actively participating in a Gilead-sponsored study of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate and receive E/C/F/TAF in this open-label extension phase.
Receives: Drug: E/C/F/TAF

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 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 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 log10 HIV-1 RNA at Weeks 24 and 48

    Measured: Baseline; Weeks 24 and 48

  3. Change From Baseline in CD4+ Cell Count at Weeks 24 and 48

    Measured: Baseline; Weeks 24 and 48

Timeline

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

  1. First posted23 Dec 2011 (estimated)
  2. Study start28 Dec 2011
  3. Primary completion17 Oct 2012
  4. Study completion22 Aug 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01497899
Sponsor's protocol ID
GS-US-292-0102
Status last verified
Aug 2017
First submitted
14 Dec 2011
Last updated
19 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

  • Sax PE, Zolopa A, Brar I, Elion R, Ortiz R, Post F, Wang H, Callebaut C, Martin H, Fordyce MW, McCallister S. Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):52-8. doi: 10.1097/QAI.0000000000000225.

    PubMed 24872136

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E/C/F/TDF and E/C/F/TAF in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 41 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 20 inclusion and 18 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 19 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 41 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 8 Jan 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 NCT01497899, which also lists 1 linked publication.

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 19 Nov 2018.

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