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Trial record 2 of 4 for:    Emtricitabine/Tenofovir Alafenamide | Recruiting Studies | Phase 3 | Industry

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 : Recruiting
First Posted : August 15, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: B/F/TAF Drug: NRTIs Drug: Third Agent Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: B/F/TAF
Participants will receive B/F/TAF FDC.
Drug: B/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
Other Name: Biktarvy®

Active Comparator: Stay on Baseline Regimen
Participants will stay on 2 NRTIs and a third agent until Week 24, with a delayed switch to B/F/TAF FDC at Week 24.
Drug: B/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
Other Name: Biktarvy®

Drug: NRTIs

NRTIs could include one of the following:

  • Abacavir (ABC)
  • Didanosine (ddI)
  • Emtricitabine (FTC)
  • Lamivudine (3TC)
  • Stavudine (d4T)
  • Tenofovir alafenamide (TAF)
  • Tenofovir disoproxil fumarate (TDF)
  • Zidovudine (ZDV or AZT)

NRTIs will be administered as prescribed until Week 24 without regard to food.


Drug: Third Agent

Third agent could include one of the following:

  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs)

    • Delavirdine (DLV)
    • Efavirenz (EFV)
    • Nevirapine (NVP)
    • Rilpivirine (RPV)
  • Integrase inhibitors

    • Dolutegravir (DTG)
    • Elvitegravir (EVG)
    • Raltegravir (RAL)
  • Protease inhibitors (PIs)

    • Atazanavir (ATV)
    • Darunavir (DRV)
    • Lopinavir
    • Nelfinavir NFV)
    • Saquinavir (SQV)
    • Tipranavir (TPV)

Third agents will be administered as prescribed without regard to food. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir.





Primary Outcome Measures :
  1. 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 ]

Secondary 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 HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 24 ]
  3. 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 ]
  4. Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  5. Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]


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:

  • Self-describes as Black, African American, or mixed race, including Black
  • Currently receiving an 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, PI 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 antiretrovirals (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)
  • 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.


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): NCT03631732


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

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Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03631732     History of Changes
Other Study ID Numbers: GS-US-380-4580
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 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:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents