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Taking peoplePhase 3

Tests a new HIV pill combination against a current HIV treatment

Tests switching to bictegravir with lenacapavir in adults with HIV-1 already well controlled.

Key facts

Who runs it
Gilead Sciences Inc.
Where
Lyon Cedex 04, Montpellier Cedex 5, Nantes, Paris, Paris Cedex 18, and Tourcoing Cedex, FranceSee the 6 sitesAlso in 3 other countries, 19 sites
Registry title
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Status
Recruiting
Phase
Phase 3
People taking part
120 people, planned
Started
3 Oct 2024
Expected to end
28 Dec 2029
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Record updated
14 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with HIV-1 whose virus is already well controlled on Biktarvy (B/F/TAF). It compares switching to bictegravir/lenacapavir with staying on Biktarvy.

Age
18 years or older
Sex
All sexes can join.
Disease stage
HIV-1 infection with virus kept below 50 copies/mL at screening and in earlier tests.
Earlier treatment
Must have taken B/F/TAF for at least 6 months before screening. Must not have had lenacapavir before.
Biomarker or test result
HIV-1 RNA below 50 copies/mL. No known or suspected resistance to bictegravir or tenofovir alafenamide. Kidney function (eGFR) above 30 mL/min.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Chronic hepatitis B infection
  • Active tuberculosis or other serious infection needing treatment through a vein
  • Decompensated liver cirrhosis
  • Active cancer needing systemic treatment

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • Aged ≥ 18 years at screening
  • Currently receiving B/F/TAF for at least 6 months prior to screening
  • If plasma HIV-1 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 (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; 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 (CLcr)
  • Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception

Who cannot take part

  • Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization
  • Acute hepatitis < 30 days before randomization
  • Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3 of 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
  • Prior use of, or exposure to, LEN
  • Active tuberculosis infection
  • Chronic hepatitis B virus (HBV) infection, as determined by either: a) Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. b) 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)
  • Active malignancy requiring acute systemic therapy
  • Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization
  • Any of the following laboratory values at screening: a) Alanine aminotransferase > 5 × upper limit of normal (ULN) b) Direct bilirubin > 1.5 × ULN c) Platelets < 50,000/mm3 d) Hemoglobin < 8.0 g/dL
  • Participants under guardianship, curatorship, or legal protection may not participate in the study
  • Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator
  • Breastfeeding (nursing)

Where in France

Also in 3 other countries, 19 sites

  • Hospices Civils De LyonLyon Cedex 04, FranceNo longer taking part
  • Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceNo longer taking part
  • Centre Hospitalier Universitaire de NantesNantes, FranceNo longer taking part
  • Assistance Publique Hopitaux de ParisParis, FranceNo longer taking part
  • Assistance Publique Hopitaux De ParisParis Cedex 18, FranceNo longer taking part
  • Centre Hospitalier De TourcoingTourcoing Cedex, FranceNo longer taking part

About the trial

What the trial wants to find out

To evaluate the efficacy of switching to bictegravir/lenacapavir (BIC/LEN) (75/50 mg) fixed-dose combination (FDC) tablets versus continuing on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets in virologically suppressed people with HIV-1

The 3 groups in the trial

  • Blinded Phase: Treatment Group 1: BIC/LEN 75/50 mgTreatment being tested

    Participants will switch from bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed-dose combination (FDC) tablets to bictegravir/lenacapavir (BIC/LEN) 75/50 mg FDC tablets + placebo-to-match (PTM) B/F/TAF tablets, administered orally, once daily up to 48 weeks. Participants will also receive a 2-day oral pharmacokinetic (PK) loading dose of LEN 600 mg on Days 1 and 2, in addition to the daily doses of BIC/LEN 75/50 mg and PTM B/F/TAF tablets starting on Day 1. At the end of blinded treatment (EBT) participants will enter the open label (OL) phase and continue to receive BIC/LEN 75 mg/50 mg FDC tablets through at least 48 weeks in the OL phase. At the OL Week 48, participants will be given an option to continue to receive BIC/LEN FDC tablets.

    Treatment: Bictegravir/Lenacapavir (BIC/LEN) FDC, Lenacapavir, and Placebo to match B/F/TAF

  • Blinded Phase: Treatment Group 2: B/F/TAF 50/200/25 mgExisting treatment, for comparison

    Participants will continue with their B/F/TAF 50/200/25 mg tablets and start PTM BIC/LEN tablets on Day 1 administered orally, once daily up to 48 weeks. Participants will receive PTM oral LEN PK loading tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2). Participants who complete the EBT will be given an option to enter the OL phase to receive BIC/LEN FDC tablets.

    Treatment: B/F/TAF, Placebo to match BIC/LEN FDC, and Placebo to match Lenacapavir

  • Open-label Phase: BIC/LEN 75/50mgTreatment being tested

    Participants from Treatment Group 1 will receive BIC/LEN FDC tablets through at least OL Week 48. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets. 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. Participants from Treatment Group 2 who enter the OL phase will also receive a 2-day oral loading dose of LEN 600 mg (2 × 300 mg LEN on Day 1 and on Day 2). All participants who enter the OL phase may continue to receive BIC/LEN FDC tablets daily until study drug is available or until Gilead Sciences (Gilead) elects to discontinue the study.

    Treatment: Bictegravir/Lenacapavir (BIC/LEN) FDC and Lenacapavir

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests a new HIV pill combination against a current HIV treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Publications
Record updated
14 August 2026