Clinical Trials

MainTitle

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
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02397694

First received: March 20, 2015
Last updated: February 27, 2018
Last Verified: February 2018
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV-1 Infection

Drug : BIC
Drug : F/TAF
Drug : DTG
Drug : BIC Placebo
Drug : DTG Placebo
Drug : B/F/TAF
Phase 2

Study Type: Interventional
Study Design: 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

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 ]
    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:
  • 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.
  • 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.
  • The Change From Baseline in log10 HIV-1 RNA at Week 12 [ Time Frame: Baseline; Week 12 ]
  • The Change From Baseline in log10 HIV-1 RNA at Week 24 [ Time Frame: Baseline; Week 24 ]
  • The Change From Baseline in log10 HIV-1 RNA at Week 48 [ Time Frame: Baseline; Week 48 ]
  • The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12 [ Time Frame: Baseline; Week 12 ]
  • The Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  • The Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 72 weeks ]
  • Number of Participants With Treatment Emergent Laboratory Abnormalities [ Time Frame: Up to 72 weeks ]
  • 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 ]
    Cmax is the maximum observed plasma concentration of the drug.
  • 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 ]
    Tmax was defined as the time to Cmax.
  • PK Parameter:Ctau for BIC, FTC and TFV [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose ]
    Ctau was defined as the observed drug concentration at the end of the dosing interval.
  • 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 ]
    AUCtau is defined as the area under the concentration-time curve of the drug over time.
  • 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 ]
    t1/2 was defined as the terminal elimination half-life of the drug

Enrollment: 98
Study Start Date: March 23, 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: October 1, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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, District of Columbia, United States, 20005
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

Study Director: Gilead Study Director Gilead Sciences
More Information

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: February 27, 2018  

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:
Tenofovir
Emtricitabine
Dolutegravir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on July 16, 2018
This information is provided by ClinicalTrials.gov.