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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02397694
First received: March 20, 2015
Last updated: June 30, 2017
Last verified: June 2017
  Purpose
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (FTC/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + FTC/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, FTC and TAF.

Condition Intervention Phase
HIV-1 Infection Drug: BIC Drug: FTC/TAF Drug: DTG Drug: BIC Placebo Drug: DTG Placebo Drug: BIC/F/TAF Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of participants with HIV-1 RNA < 50 copies/mL as determined by the FDA-defined snapshot algorithm. [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • Percentage of participants with HIV-1 RNA < 50 copies/mL as determined by the FDA-defined snapshot algorithm. [ Time Frame: Week 12 ]
  • Percentage of participants with HIV-1 RNA < 50 copies/mL as determined by the FDA-defined snapshot algorithm. [ Time Frame: Week 48 ]
  • The change from baseline in log10 HIV-1 RNA and in CD4+ cell count [ Time Frame: Weeks 12, 24 and 48 ]
  • The incidence of treatment-emergent adverse events (AEs) and treatment-emergent laboratory abnormalities. [ Time Frame: Up to 1 year ]
  • Maximum observed plasma concentration (Cmax) of BIC, FTC, and TAF [ Time Frame: Week 4 or 8 ]
    For a subset of participants who enroll in the PK substudy.

  • Time to maximum observed plasma concentration (Tmax) of BIC, FTC, and TAF [ Time Frame: Week 4 or 8 ]
    For a subset of participants who enroll in the PK substudy.

  • Observed drug concentration at the end of the dosing interval (Ctau) for BIC, FTC, and TAF [ Time Frame: Week 4 or 8 ]
    For a subset of participants who enroll in the PK substudy.

  • Area under the concentration-time curve over the dosing interval (AUCtau) for BIC, FTC, and TAF [ Time Frame: Week 4 or 8 ]
    For a subset of participants who enroll in the PK substudy. AUCtau is defined as concentration of drug over time.

  • Estimate of the terminal elimination half-life (t1/2) of BIC, FTC, and TAF [ Time Frame: Week 4 or 8 ]
    For a subset of participants who enroll in the PK substudy.

  • Trough plasma concentrations for BIC, FTC, and TAF [ Time Frame: Weeks 4, 8, 12 and 24 ]
    This endpoint will measure the plasma concentrations of BIC, FTC, and TAF.


Enrollment: 98
Study Start Date: March 2015
Estimated Study Completion Date: January 2019
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIC + FTC/TAF

Participants will receive BIC + FTC/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 (BIC/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: FTC/TAF
200/25 mg FDC tablet administered orally once daily
Drug: DTG Placebo
Tablet administered orally once daily
Drug: BIC/F/TAF
50/200/25 mg FDC tablet administered orally once daily
Active Comparator: DTG + FTC/TAF

Participants will receive DTG + FTC/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 BIC/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
Drug: FTC/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: BIC/F/TAF
50/200/25 mg FDC tablet administered orally once daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02397694

Locations
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, D.C., District of Columbia, United States, 20009
Washington, D.C., 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
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02397694     History of Changes
Other Study ID Numbers: GS-US-141-1475
Study First Received: March 20, 2015
Last Updated: June 30, 2017

Keywords provided by Gilead Sciences:
Adult
HIV
naive

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 25, 2017