Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
- Conditions
- HIV-1-infection
- Interventions
- Drug: B/F/TAFDrug: Placebo to match B/F/TAFDrug: Placebo to match BIC/LEN
- Registration Number
- NCT06333808
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).
The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 577
- Currently receiving B/F/TAF for at least 6 months prior to screening.
- If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
- At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL.
- Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
- No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
- Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance.
Key
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Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
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Breastfeeding (nursing).
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Prior use of, or exposure to, LEN.
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Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.
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Active tuberculosis infection.
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Acute hepatitis < 30 days before randomization.
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Chronic hepatitis B virus (HBV) infection, as determined by either:
- Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
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Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.
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History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
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Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
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Active malignancy requiring acute systemic therapy.
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Any of the following laboratory values at screening:
- Alanine aminotransferase > 5 × upper limit of normal (ULN).
- Direct bilirubin > 1.5 × ULN.
- Platelets < 50,000/mm^3.
- Hemoglobin < 8.0 g/dL.
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Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol.
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Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
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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 dosing requirements.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF Lenacapavir Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN Lenacapavir Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN B/F/TAF Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN Placebo to match BIC/LEN Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF Placebo to match B/F/TAF Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF Bictegravir Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN Bictegravir Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.
- Primary Outcome Measures
Name Time Method Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm Week 48
- Secondary Outcome Measures
Name Time Method Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96 Baseline; Week 96 Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96 From first dose date up to Week 96 Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm Week 48 Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm Week 96 Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm Week 96 Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48 From first dose date up to Week 48 Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48 Baseline; Week 48
Trial Locations
- Locations (102)
Pueblo Family Physicians
🇺🇸Phoenix, Arizona, United States
Be Well Medical Center
🇺🇸Berkeley, California, United States
Pacific Oaks Medical Group
🇺🇸Beverly Hills, California, United States
Ruane Clinical Research Group Inc.
🇺🇸Los Angeles, California, United States
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
🇺🇸Oakland, California, United States
BIOS Clinical Research
🇺🇸Palm Springs, California, United States
UCSD Anti Viral Research Centre (AVRC)
🇺🇸San Diego, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Mills Clinical Research
🇺🇸West Hollywood, California, United States
Public Health Institute at Denver Health
🇺🇸Denver, Colorado, United States
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