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NCT07908446Not yet recruitingPhase 4

Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV

Phase 4, Randomized, Open-label, Non-inferiority Trial of Bictegravir/Lenacapavir Fixed-dose Combination (BIC/LEN FDC) Versus Stable Baseline Regimens (SBR) in Virologically Suppressed (VS) People With HIV (PWH)

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

The goal of this clinical trial is to assess the effectiveness and safety of switching to bictegravir/lenacapavir (BIC/LEN) fixed-dose combination (FDC) compared with continuing stable baseline regimens (SBR) in virologically suppressed people with HIV. The primary objective of this study is to evaluate the efficacy of switching to BIC/LEN (75/50 mg) fixed-dose combination (FDC) tablets versus continuing their stable baseline regimen (SBR) in virologically suppressed people with HIV.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
400 (estimated)
First submitted
26 Oct 2026
Start date
1 Nov 2026
Primary completion date
31 Jul 2028
Lead sponsor
Gilead Sciences
Diseases
HIV
NCT number
NCT07908446

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 400
  • From 1 Nov 2026 to the primary completion date, 31 Jul 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently receiving renal replacement therapy (eg, hemodialysis)
  • Requirement for ongoing therapy with any prohibited medications listed for BIC/LEN FDC
  • Prior use of, or exposure to, LEN
  • Ongoing treatment with BIC/FTC/TAF
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other illness

  • Chronic hepatitis B virus (HBV)
  • Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
  • History of, or current severe decompensated cirrhosis

Other

  • Actively pregnant or breastfeeding (nursing)
  • Documented or suspected resistance to BIC

Who the study is looking for

  • Currently receiving a SBR defined as (1) integrase strand-transfer inhibitor (INSTI) + 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) (excluding bictegravir/emtricitabine/tenofovir alafenamide (BIC/emtricitabine (FTC)/tenofovir alafenamide (TAF)), (2) boosted-protease inhibitor (PI) + 2 NRTIs, (3) nonnucleoside reverse transcriptase inhibitor (NNRTI) + 2 NRTIs, (4) dolutegravir (DTG)/RPV or (5) cabotegravir (CAB)/rilpivirine (RPV) for at least 3 months without switch prior to screening, and willing to continue their SBR through at least Week 24.
  • HIV-1 RNA \< 50 copies/mL for ≥ 3 months before screening
  • Estimated creatinine clearance (eCLcr) rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) at screening
  • Plasma HIV-1 RNA levels \< 50 copies/mL at screening

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.