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HIV-1 InfectionPhase 3NCT02600819

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

A Phase 3 study testing E/C/F/TAF and B/F/TAF in people with HIV-1 Infection, run by Gilead Sciences at 26 sites in 4 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

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
E/C/F/TAF and B/F/TAF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
26 sitesin 4 countries
Study dates
14 Dec 2015to 15 Oct 2019
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

  • Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
  • Plasma HIV-1 ribonucleic acid (RNA) concentrations < 50 copies/mL for ≥ 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
  • No documented history of HIV-1 resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV) and no history of switching off EVG, FTC, 3TC or TFV due to concern for resistance
  • Cluster determinant 4 (CD4+) T cell count ≥ 200 cells/μL
  • ESRD with estimated glomerular filtration rate (eGFR) < 15 mL/min by Cockcroft-Gault formula for creatinine clearance
  • On chronic HD for ≥ 6 months prior to screening
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)

Who cannot join

  • Hepatitis B co-infection
  • Any clinical history, condition, or test result that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Administration of other investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial, including observational trials, without prior approval from the sponsor is prohibited while participating in this trial.
  • History or presence of allergy or intolerance to the study drugs or their components
  • A new acquired immunodeficiency syndrome (AIDS)-defining condition (excluding CD4+ T cell count and percentage criteria) diagnosed within the 30 days prior to screening, with the exception of oropharyngeal candidiasis
  • Received solid organ or bone marrow transplant
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

26 sites in 4 countries.

26 sites in 4 countries

United States19 sites

  • Medical College of Georgia

    Augusta, Georgia

  • University of North Carolina at Chapel Hill / UNC School of Medicine

    Chapel Hill, North Carolina

  • University of Cincinnati Med Center

    Cincinnati, Ohio

  • MetroHealth Medical Center IRB

    Cleveland, Ohio

  • North Texas Infectious Diseases Consultants

    Dallas, Texas

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia

  • Henry Ford Health System

    Detroit, Michigan

  • Duke University

    Durham, North Carolina

  • Trinity Health and Wellness Center

    Fort Worth, Texas

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida

  • Gordon E. Crofoot MD PA

    Houston, Texas

  • Peter J Ruane MD Inc

    Los Angeles, California

  • Mercer University School of Medicine

    Macon, Georgia

  • Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center

    Newark, New Jersey

  • Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center

    Orlando, Florida

  • University of California Davis

    Sacramento, California

  • The Research Institute

    Springfield, Massachusetts

  • Triple O Research Institute PA

    West Palm Beach, Florida

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina

Other trials in United States

France5 sites

  • Hopital Henri Mondor

    Créteil

  • CHU de Nice-l Archet

    Nice

  • Hopital Bichat-Claude Bernard

    Paris

  • Hopital Saint Louis

    Paris

  • Centre Hospitalier de Tourcoing

    Tourcoing

Other trials in France

Austria1 site

  • Otto Wagner Spital

    Vienna

Other trials in Austria

Germany1 site

  • Klinikum rechts der Isar, TUM

    München

Other trials in Germany

About this study

Official title: A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).

Conditions
HIV-1 Infection
Being tested
E/C/F/TAF, B/F/TAF
Keywords
End stage renal disease, Hemodialysis, Open-label, HIV-1 Infection
Medical subject headings
Kidney Failure, Chronic

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 tablets administered orally once daily

  • B/F/TAFDrug

    Also called Biktarvy®

    50/200/25 mg FDC tablets administered orally once daily

Study groups in NCT02600819
Study groupRoleWhat they receive
E/C/F/TAFExperimentalParticipants will switch their current antiretroviral regimen to E/C/F/TAF and receive treatment for 96 weeks. After Week 96, participants in the United States (US) who wish to participate in the open-label (OL) rollover extension will continue to take E/C/F/TAF FDC until the End of E/C/F/TAF Visit.
Receives: Drug: E/C/F/TAF
Open-Label Rollover Extension B/F/TAFExperimentalAt Week 96 or the End of E/C/F/TAF Visit (whichever occurs last), participants will be given the option to receive open-label bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks.
Receives: Drug: B/F/TAF

What is being measured

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

  1. GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48

    Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug or all AEs for participants still on E/C/F/TAF. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening).

    Measured: First Dose Date Up to Week 48

Secondary outcomes (15)

  1. GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96

    Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug for participants who did not participate in the BVY OL extension phase or the day prior to the date of the first B/F/TAF study drug dose for participants who participated in the BVY OL extension phase. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening).

    Measured: First Dose Date Up to Week 96

  2. GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant'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

  3. GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant'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

  4. GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant'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 96

  5. Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV)

    AUCtau is defined as area under the concentration versus time curve over the dosing interval (i.e., concentration of drug over time).

    Measured: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4

  6. PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV

    AUClast is defined as the area under the concentration versus time curve from time zero to the last observable concentration.

    Measured: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4

  7. PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV

    Cmax is defined as the maximum concentration of drug.

    Measured: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4

  8. PK Parameter: Ctau of EVG, COBI, FTC, and TFV

    Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau has been presented in lieu of Cmin (specified in the protocol) to align with other Gilead studies. This change has no impact on the PK analysis as Ctau and Cmin are equivalent for all analytes.

    Measured: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4

  9. GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Failure (M = F) Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL.

    Measured: Week 96

  10. GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Excluded (M = E) Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.

    Measured: Week 96

  11. BVY OL Extension Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.

    Measured: Week 48 of the BVY OL Extension Phase

  12. GEN Phase: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 96

    Measured: Baseline; Week 96

  13. BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48

    Measured: Baseline; Week 48 of the BVY OL Extension Phase

  14. GEN Phase: Change From Baseline in CD4 Percentage at Week 96

    Measured: Baseline; Week 96

  15. BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48

    Measured: Baseline; Week 48 of the BVY OL Extension Phase

Timeline

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

  1. First posted9 Nov 2015 (estimated)
  2. Study start14 Dec 2015
  3. Primary completion29 Sep 2017
  4. Study completion15 Oct 2019

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
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02600819
Sponsor's protocol ID
GS-US-292-1825
Other IDs
2015-002713-30, 2015
Status last verified
Oct 2020
First submitted
6 Nov 2015
Last updated
5 Nov 2020
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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Publications

  • Eron JJ Jr, Lelievre JD, Kalayjian R, Slim J, Wurapa AK, Stephens JL, McDonald C, Cua E, Wilkin A, Schmied B, McKellar M, Cox S, Majeed SR, Jiang S, Cheng A, Das M, SenGupta D. Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial. Lancet HIV. 2018 Dec 13:S2352-3018(18)30296-0. doi: 10.1016/S2352-3018(18)30296-0. Online ahead of print.

    PubMed 30555051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E/C/F/TAF and B/F/TAF in people with HIV-1 Infection, run by Gilead Sciences at 26 sites in 4 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 7 inclusion and 7 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, France, Austria, Germany. 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 16 Oct 2018). 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?

GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48 (time frame: First Dose Date Up to Week 48). 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 NCT02600819, 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 5 Nov 2020.

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