FindTrial
Sign In

A Phase 3, Randomized, Double-Blind, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF).

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514046-37-00
Acronym
GS-US-563-5925
Enrollment
87
Registered
2024-12-10
Start date
2025-01-16
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection

Brief summary

The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm [Time Frame: Week 48]

Detailed description

Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm, Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 as Determined by the US FDA-Defined Snapshot Algorithm, The change from baseline in CD4+ T-cell count at Weeks 48 and 96, Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (AEs)

Interventions

DRUGBiktarvy 50 mg/200 mg/25 mg film-coated tablets
DRUGPTM ISL/LEN
DRUGISLATRAVIR/LENACAPAVIR
DRUGPTM Biktarvy

Sponsors

Gilead Sciences Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm [Time Frame: Week 48]—

Secondary

MeasureTime frame
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm, Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 as Determined by the US FDA-Defined Snapshot Algorithm, The change from baseline in CD4+ T-cell count at Weeks 48 and 96, Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (AEs)—

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026