Active — Not RecruitingPhase 3

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

United States, Argentina, Australia577 participantsStarted 2024-03-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. *…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is comparing a new two-drug combination of bictegravir and lenacapavir against my current Biktarvy regimen, can you help me understand what potential advantage this switch might offer me if I'm already doing well on Biktarvy?
2The trial is measuring how many participants still have detectable HIV levels — defined as HIV-1 RNA at or above 50 copies/mL — at 48 weeks, so what would it mean for my care if the new combination performed worse on that measure than my current therapy?
3Since this is a Phase 3 trial and it's no longer actively recruiting, does that affect whether I could still be considered for participation, and if not, when might results from this study be available to inform my treatment options?
4Lenacapavir is a newer type of HIV drug called a capsid inhibitor — given that it works differently from the drugs in Biktarvy, what do you know so far about its safety profile and whether there are any side effects I should be aware of when it's combined with bictegravir?
5Given that I'm currently stable on Biktarvy, would switching to a new combination in a trial setting carry any risks to my viral suppression, and is staying on my current regimen the more cautious path right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

Timeframe: Week 48

Trial details

NCT IDNCT06333808

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-27

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