Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Keywords

HIV-1-infection, Bictegravir, Lenacapavir, B/F/TAF

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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/mm3.
    • 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.

Locations

  • UCSD Anti Viral Research Centre (AVRC) accepting new patients
    San Diego California 92103 United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT06333808
Phase
Phase 3 HIV/AIDS Research Study
Study Type
Interventional
Participants
Expecting 546 study participants
Last Updated