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HIVPhase 3NCT02071082

Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

A Phase 3 study testing E/C/F/TAF in people with HIV and HBV, run by Gilead Sciences at 24 sites in 3 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 will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, HBV
What is being tested?
E/C/F/TAF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
24 sitesin 3 countries
Study dates
25 Feb 2014to 26 Oct 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

  • Both Cohorts 1 and 2:
  • The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • HIV/HBV co-infected adult males and non-pregnant and non-lactating females
  • No evidence of hepatocellular carcinoma (HCC) or clinical or imaging evidence of cirrhosis (ascites, variceal bleeding, encephalopathy).
  • --- Subjects should have documentation of an abdominal ultrasound in the 12 months prior to screening, or an abdominal ultrasound at screening, demonstrating the absence of cirrhosis and HCC.
  • Acute Hepatitis A virus (HAV) immunoglobulin M (IgM) negative
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  • Hepatitis C virus (HCV) Ab negative, or HCV Ab positive with negative HCV RNA
  • Hepatitis D virus (HDV) Ab negative, or HDV Ab positive with negative HDV RNA
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula
  • CD4+ count of > 200 cells/μL
  • Chronic HBV infection as defined by
  • HBsAg positive for ≥ 6 months Or
  • HBsAg positive at screening and either hepatitis B e antigen (HBeAg) or HBV DNA positive ≥ 6 months Or
  • At screening: positive total hepatitis B core antibody (HBcAb) and negative immunoglobulin M antibody to hepatitis B core antigen (HBcIgM) antibody, and
  • HBsAg positive, or
  • HBeAg positive, or
  • HBV DNA positive
  • Cohort 1 (HIV and HBV treatment naive) only:
  • No current or prior anti-HIV treatment, including antiretroviral medications received for prevention (PrEP), or post exposure prophylaxis (PEP)
  • No current or prior anti-HBV treatment
  • Plasma HIV-1 RNA level ≥ 500 copies/mL at screening
  • Screening HBV DNA ≥ 3 log10 IU/mL and < 9 log10 IU/mL
  • Cohort 2 (HIV suppressed) only:
  • Receiving current antiretroviral regimen for at least 4 consecutive months
  • No current or prior regimen containing 3 active anti-HBV agents (i.e. cannot be on tenofovir alafenamide (TDF)/emtricitabine (FTC)/Entecavir or TDF/lamivudine(3TC)/Entecavir)
  • Maintained plasma HIV-1 RNA < 50 copies/mL for 6 consecutive months prior to and at the time of the screening visit. Unconfirmed virologic evaluation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
  • Documented positive HIV antibody test
  • Screening HBV DNA < 9 log10 IU/mL

Who cannot join

  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use
  • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive carcinoma.
  • Received solid organ or bone marrow transplant
Show all 13Show fewer
  • Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
  • Significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses), or multiple bone fractures
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
  • Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone, and dexamethasone)
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
  • Investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

24 sites in 3 countries.

24 sites in 3 countries

United States21 sites

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • St. Hope Foundation

    Bellaire, Texas

  • Be Well Medical Center PC

    Berkley, Michigan, 48072

  • AHF Research Center

    Beverly Hills, California, 90211

  • Barry M. Rodwick MD

    Clearwater, Florida, 33765

  • North Texas Infectious Diseases Consultants

    Dallas, Texas, 75246

  • Gary J Richmond M.D.,P.A.

    Fort Lauderdale, Florida, 33316

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • Therapeutic Concepts

    Houston, Texas, 77004

  • Gordon E. Crofoot MD PA

    Houston, Texas, 77098

  • KC Care Clinic

    Kansas City, Missouri, 64111

  • Peter J. Ruane MD, Inc.

    Los Angeles, California, 90036

  • Anthony Mills MD, Inc

    Los Angeles, California, 90069

  • AIDS Health Foundation/WPA

    Miami Beach, Florida, 33139

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • Southwest CARE Center

    Santa Fe, New Mexico, 87505

  • Peter Shalit MD

    Seattle, Washington, 98104

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • AIDS Research and Treatment Center of the Treasure Coast

    Vero Beach, Florida, 32960

  • Whitman Walker Health

    Washington D.C., District of Columbia, 20009

  • Triple O Research Institute PA

    West Palm Beach, Florida, 33401

Other trials in United States

Canada2 sites

  • University Health Network/Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Maple Leaf Research/Maple Leaf Medical Clinic

    Toronto, Ontario, M5G1K2

Other trials in Canada

Japan1 site

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo, 1628655

Other trials in Japan

About this study

Official title: A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults

This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults.

Participants will be enrolled into two cohorts:

  • Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive
  • Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
Conditions
HIV, HBV
Being tested
E/C/F/TAF
Keywords
HIV, HBV, Coinfection
Medical subject headings
Coinfection

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®

    E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food

Study groups in NCT02071082
Study groupRoleWhat they receive
HIV treatment-naive and HBV treatment-naiveExperimentalHIV/HBV coinfected participants who are HIV treatment-naive and HBV treatment-naive will receive E/C/F/TAF for 48 weeks.
Receives: Drug: E/C/F/TAF
HIV-suppressedExperimentalHIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
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 Plasma HIV-1 RNA Level < 50 Copies/mL

    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

  2. Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL

    The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.

    Measured: Week 24

Secondary outcomes (10)

  1. Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL

    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. Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL

    The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.

    Measured: Week 48

  3. Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24

    ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

    Measured: Baseline; Week 24

  4. Percentage of Participants With Normalized ALT at Week 48

    ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

    Measured: Baseline; Week 48

  5. Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24

    Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.

    Measured: Baseline; Week 24

  6. Percentage of Participants With Seroconversion to Anti-HBs at Week 48

    Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.

    Measured: Baseline; Week 48

  7. Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24

    Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.

    Measured: Baseline; Week 24

  8. Percentage of Participants With Seroconversion to Anti-HBe at Week 48

    Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.

    Measured: Baseline; Week 48

  9. Change From Baseline in FibroTest® Score at Week 24

    The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.

    Measured: Baseline; Week 24

  10. Change From Baseline in FibroTest® Score at Week 48

    The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.

    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 posted25 Feb 2014 (estimated)
  2. Study start25 Feb 2014
  3. Primary completion23 Jan 2015
  4. Study completion26 Oct 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02071082
Sponsor's protocol ID
GS-US-292-1249
Status last verified
Oct 2017
First submitted
21 Feb 2014
Last updated
16 Nov 2018
Data monitoring committee
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E/C/F/TAF in people with HIV and HBV, run by Gilead Sciences at 24 sites in 3 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 28 inclusion and 13 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 24 sites in United States, Canada, Japan. 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 4 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 Plasma HIV-1 RNA Level < 50 Copies/mL (time frame: Week 24). The study lists 2 primary outcomes in all. 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 NCT02071082.

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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