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Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

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ClinicalTrials.gov Identifier: NCT03547908
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV) treatment naive, HIV-1 and HBV co-infected adults.

Condition or disease Intervention/treatment Phase
HIV-1/HBV Co-Infection Drug: B/F/TAF Drug: Placebo to match DTG Drug: Placebo to match F/TDF Drug: DTG Drug: F/TDF Drug: Placebo to match B/F/TAF Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
Experimental: B/F/TAF
B/F/TAF + placebo to match DTG + placebo to match F/TDF
Drug: B/F/TAF
50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
Other Name: Biktarvy®

Drug: Placebo to match DTG
Tablet administered orally once daily, without regard to food

Drug: Placebo to match F/TDF
Tablet administered orally once daily, without regard to food

Experimental: DTG+F/TDF
DTG + F/TDF + placebo to match B/F/TAF
Drug: DTG
50 mg tablet administered orally once daily, without regard to food

Drug: F/TDF
200/300 mg tablet administered orally once daily, without regard to food
Other Name: Truvada®

Drug: Placebo to match B/F/TAF
Tablet administered orally once daily, without regard to food




Primary Outcome Measures :
  1. Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
  2. Proportion of Participants With Plasma HBV DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]
  2. Change from Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  3. Change from Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline; Week 96 ]
  4. Change from Baseline in CD4 Percentage at Week 48 [ Time Frame: Baseline; Week 48 ]
  5. Change from Baseline in CD4 Percentage at Week 96 [ Time Frame: Baseline; Week 96 ]
  6. Proportion of Participants With Plasma HBV DNA < 29 IU/mL at Week 96 [ Time Frame: Week 96 ]
  7. Proportion of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 [ Time Frame: Week 48 ]
  8. Proportion of Participants With ALT Normalization at Week 96 [ Time Frame: Week 96 ]
  9. Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 [ Time Frame: Week 48 ]
  10. Proportion of Participants With HBsAg Loss at Week 96 [ Time Frame: Week 96 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • HIV-1 co-infection:

    • Must be HIV antiretroviral treatment naive with plasma HIV-1 RNA ≥ 500 copies/mL at screening
    • ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine and entecavir, following a diagnosis of HIV-1 infection (except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening)
    • Screening genotype report must show sensitivity to emtricitabine (FTC) and tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively, if genotype results from a local laboratory obtained ≤ 90 days prior to screening visit date show sensitivity to these drugs, this genotype will be acceptable to fulfill this inclusion criterion in the event that the genotype obtained at screening is not yet available and all other inclusion/exclusion criteria have been confirmed
  • HBV co-infection:

    • Must be HBV treatment naive (defined as < 12 weeks of oral antiviral treatment)
    • Screening HBV DNA ≥ 2000 IU/mL
  • Hepatic transaminases (aspartate aminotransferase (AST) and ALT) ≤ 10 x upper limit of normal (ULN)
  • Total bilirubin ≤ 2.5 x ULN

Key Exclusion Criteria:

  • Hepatitis C virus (HCV) antibody positive and HCV RNA detectable
  • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment
  • Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
  • Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
  • Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547908


Contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

  Show 31 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03547908     History of Changes
Other Study ID Numbers: GS-US-380-4458
2018-000926-79 ( EudraCT Number )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis B
Coinfection
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Infection
Parasitic Diseases
Tenofovir
Emtricitabine
Dolutegravir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors