NCT05502341ACTIVE_NOT_RECRUITINGanonymous

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Sponsor

Source record

Gilead Sciences

Phase

Source record

Phase 2/3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

HIV-1 infection

Indication / condition

AI-normalized

HIV-1-infection

Intervention

Source record

Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen

Source & freshness

Source record

NCT ID

NCT05502341

Original source

ClinicalTrials.gov

Source last updated

Oct 14, 2025

Ingested at

May 23, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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NCT ID

NCT05502341

Title

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Sponsor

Gilead Sciences

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 2/3

Condition raw

HIV-1-infection

Condition normalized

HIV-1-infection

Modality raw

HIV-1-infection

Modality normalized

monoclonal antibody

Target raw

HIV-1 infection

Target normalized

HIV-1 infection

Interventions

Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen

Public preview

Source record

This clinical trial, sponsored by Gilead Sciences, aims to evaluate the safety and efficacy of Bictegravir (BIC) and Lenacapavir (LEN) compared to current therapies in patients with HIV-1 who are virologically suppressed on complex treatment regimens. The study is designed as a randomized, open-label, multicenter trial with a total enrollment of 689 participants.

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Investment-Ready Snapshot

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Source & freshness

Public preview

Create an account to unlock this report

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Investment-Ready Snapshot

Provenance

Protocol Description

Outcome Measures

Eligibility

Known Results And Readout Context

Patent And IP Landscape

Contacts