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Clinical Trials in Canada / NCT06333808
Active, not recruiting Phase 3

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

NCT06333808 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2024-03-25
Last updated
2026-06-15

Condition(s) studied

HIV-1-infection

Investigational drug(s) / intervention(s)

Bictegravir →Lenacapavir →B/F/TAF →Placebo to match B/F/TAFPlacebo to match BIC/LEN

Bictegravir: Tablets administered orally without regard to food

Lenacapavir: Tablets administered orally without regard to food

B/F/TAF: Tablets administered orally without regard to food

Placebo to match B/F/TAF: Tablets administered orally without regard to food

Placebo to match BIC/LEN: Tablets administered orally without regard to food

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * 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 Exclusion Criteria: * Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization. * Breastfeeding (nursing). * Prior use of, or exposure to, LEN. * Active, serious infections (other than HIV-1) requiring parenteral therapy \< 30 days prior to randomization. * Active tuberculosis infection. * Acute hepatitis \< 30 days before randomization. * 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. * Known hypersensitivity to the study drug, its metabolites, or any formulation excipient. * History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding). * Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator. * Active malignancy requiring acute systemic therapy. * 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. * Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. * Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor. * 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.

Primary outcome measure(s)

Trial sites (104)

FacilityCityRegionStatus
Pueblo Family Physicians Phoenix Arizona
Be Well Medical Center Berkeley California
Pacific Oaks Medical Group Beverly Hills California
Ruane Clinical Research Group Inc. Los Angeles California
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care Oakland California
BIOS Clinical Research Palm Springs California
UCSD Anti Viral Research Centre (AVRC) San Diego California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
Mills Clinical Research West Hollywood California
Public Health Institute at Denver Health Denver Colorado
Yale University School of Medicine (study visits) New Haven Connecticut
Midland Florida Infectious Diseases Specialists, PL - Orange City DeLand Florida
Therafirst Medical Center Fort Lauderdale Florida
CAN Community Health Fort Lauderdale Florida
Midway Immunology and Research Center Ft. Pierce Florida
AIDS Healthcare Foundation - The Kinder Medical Group Miami Florida
Schiff Center for liver Diseases/University of Miami Miami Florida
Floridian Clinical Research Miami Lakes Florida
Orlando Immunology Center Orlando Florida
Bliss Healthcare Orlando Florida
AHF Pensacola Pensacola Florida
CAN community Health Sarasota Florida
Triple O Research Institute, P.A. West Palm Beach Florida
Infectious Disease Specialists of Atlanta Decatur Georgia
Mercer University, Department of Internal Medicine Macon Georgia
Claudia T Martorell MD LLC dba The Research Institute Springfield Massachusetts
Henry Ford Health Detroit Michigan
KC Care health Center Kansas City Missouri
Southampton Community Healthcare, Inc. St Louis Missouri
ID Care, LLC Hillsborough New Jersey
Saint Michael's Medical Center Newark New Jersey
New Jersey Medical School - Clinical Research Center Newark New Jersey
South Jersey Infectious Disease Somers Point New Jersey
AXCES Research Group, LLC Santa Fe New Mexico
New York-Presbyterian Queens Flushing New York
Montefiore Medical Center The Bronx New York
The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care Greenville North Carolina
Rosedale Health and Wellness Huntersville North Carolina
Philadelphia FIGHT Community Health Centers Philadelphia Pennsylvania
Medical University of South Carolina (MUSC) Research Nexus Charleston South Carolina

+ 64 more sites — see the full list on the official registry below.

More Gilead Sciences trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06333808 on ClinicalTrials.gov ↗ ← All trials in Canada