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Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants (BRAAVE 2020)

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ClinicalTrials.gov Identifier: NCT03631732
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Results First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 15, 2018
Results First Submitted Date  ICMJE August 12, 2020
Results First Posted Date  ICMJE August 27, 2020
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE August 28, 2018
Actual Primary Completion Date August 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2020)
Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set [ Time Frame: Week 24 ]
The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2020)
  • Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set [ Time Frame: Week 48 ]
    The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 were analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
  • Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set [ Time Frame: Week 24 ]
    The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined 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 Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set [ Time Frame: Week 24 ]
    The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined 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 Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set [ Time Frame: Week 48 ]
    The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 48 were analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
  • Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set [ Time Frame: Baseline to Week 24 ]
    The analysis includes values up to 1 day after permanent discontinuation of study treatment.
  • Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set [ Time Frame: Baseline to Week 24 ]
    The analysis includes values up to 1 day after permanent discontinuation of study treatment.
  • Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set [ Time Frame: Baseline to Week 48 ]
    The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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 ]
  • Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 24 ]
  • 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 ]
  • Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
Official Title  ICMJE A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
Brief Summary The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed african american participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Drug: B/F/TAF
    50/200/25 mg FDC tablets administered orally once daily without regard to food
    Other Name: Biktarvy®
  • Drug: NRTIs

    The following NRTIs will be administered as prescribed until Week 24 without regard to food:

    abacavir (ABC), emtricitabine (FTC), lamivudine (3TC), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), zidovudine (ZDV or AZT)

  • Drug: Third Agent

    Any one of the following third agents will be administered as prescribed. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir. :

    • Non-nucleoside reverse transcriptase inhibitors (NNRTIs)

      • delavirdine (DLV)
      • efavirenz (EFV)
      • nevirapine (NVP)
      • rilpivirine (RPV)
      • doravirine (DOR)
    • Integrase inhibitors

      • dolutegravir (DTG)
      • elvitegravir (EVG)
      • raltegravir (RAL)
    • Protease inhibitors (PIs)

      • atazanavir (ATV)
      • darunavir (DRV)
      • lopinavir (LPV)
      • nelfinavir NFV)
      • saquinavir (SQV)
      • tipranavir (TPV)
      • maraviroc (MVC)
Study Arms  ICMJE
  • Experimental: B/F/TAF
    Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
    Intervention: Drug: B/F/TAF
  • Active Comparator: Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF
    Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily with a delayed switch to FDC tablet of B/F/TAF (50/200/25 mg) administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
    Interventions:
    • Drug: B/F/TAF
    • Drug: NRTIs
    • Drug: Third Agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 27, 2019)
496
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
480
Estimated Study Completion Date  ICMJE August 2020
Actual Primary Completion Date August 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Self-describes as Black, African American, or mixed race, including Black
  • Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months
  • Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc
  • If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded
  • Baseline regimens containing investigational drugs or > 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI)
  • Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving <50 copies/mL while on an INSTI-containing regimen)
  • History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded
  • Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit
  • HIV-1 RNA levels < 50 copies/mL at Screening
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance

Key Exclusion Criteria:

  • History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT
  • No desire to switch from current ARVs
  • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
  • Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)
  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
  • Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed
  • Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance
  • Active, serious infections (other than HIV-1 infection) requiring 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
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements
  • Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient
  • Females who are pregnant (as confirmed by positive serum pregnancy test)
  • Females who are breastfeeding
  • Acute hepatitis in the 30 days prior to randomization
  • Active tuberculosis infection.

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03631732
Other Study ID Numbers  ICMJE GS-US-380-4580
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP