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Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397694
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : March 27, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: BIC Drug: F/TAF Drug: DTG Drug: BIC Placebo Drug: DTG Placebo Drug: B/F/TAF Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : February 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: BIC + F/TAF

Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.

  • Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
Drug: BIC
75 mg tablet administered orally once daily
Other Name: GS-9883

Drug: F/TAF
200/25 mg FDC tablet administered orally once daily

Drug: DTG Placebo
Tablet administered orally once daily

Drug: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily

Active Comparator: DTG + F/TAF

Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.

  • Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
Drug: F/TAF
200/25 mg FDC tablet administered orally once daily

Drug: DTG
50 mg tablet administered orally once daily
Other Name: Tivicay®

Drug: BIC Placebo
Tablet administered orally once daily

Drug: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily

Experimental: Open Label Extension Phase
After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF.
Drug: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily




Primary Outcome Measures :
  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm. [ Time Frame: 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 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.


Secondary Outcome Measures :
  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12 [ Time Frame: Week 12 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 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.

  2. Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48 [ Time Frame: 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 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.

  3. The Change From Baseline in log10 HIV-1 RNA at Week 12 [ Time Frame: Baseline; Week 12 ]
  4. The Change From Baseline in log10 HIV-1 RNA at Week 24 [ Time Frame: Baseline; Week 24 ]
  5. The Change From Baseline in log10 HIV-1 RNA at Week 48 [ Time Frame: Baseline; Week 48 ]
  6. The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12 [ Time Frame: Baseline; Week 12 ]
  7. The Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  8. The Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  9. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase [ Time Frame: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase) ]
  10. Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase [ Time Frame: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase) ]
  11. PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 ]
    Cmax is the maximum observed plasma concentration of the drug.

  12. PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 ]
    Tmax was defined as the time to Cmax.

  13. PK Parameter:Ctau for BIC, FTC and TFV [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 ]
    Ctau was defined as the observed drug concentration at the end of the dosing interval.

  14. PK Parameter: AUCtau for BIC, FTC, TAF, and TFV [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 ]
    AUCtau is defined as the area under the concentration-time curve of the drug over time.

  15. PK Parameter: t1/2 of BIC, FTC, TAF, and TFV [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 ]
    t1/2 was defined as the terminal elimination half-life of the drug



Information from the National Library of Medicine

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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:

  • Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)
  • Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
  • Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
  • Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
  • CD4+ cell count ≥ 200 cells/µL at screening

Key Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol
  • Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
  • Chronic hepatitis B virus (HBV) infection
  • Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
  • 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 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): NCT02397694


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85012
United States, California
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90069
Sacramento, California, United States, 95817
United States, District of Columbia
Washington, District of Columbia, United States, 20009
Washington, District of Columbia, United States, 20036
United States, Florida
Fort Lauderdale, Florida, United States, 33316
Orlando, Florida, United States, 32803
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta, Georgia, United States, 30312
Decatur, Georgia, United States, 30033
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Michigan
Berkley, Michigan, United States, 48072
United States, New Jersey
Newark, New Jersey, United States, 07102
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75208
Houston, Texas, United States, 77004
Houston, Texas, United States, 77098
Longview, Texas, United States, 75605
United States, Virginia
Annandale, Virginia, United States, 22003
United States, Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Publications of Results:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02397694    
Other Study ID Numbers: GS-US-141-1475
First Posted: March 25, 2015    Key Record Dates
Results First Posted: March 27, 2018
Last Update Posted: April 7, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Adult
HIV
naive
Additional relevant MeSH terms:
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Dolutegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents