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

NCT06333808 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 577

Last updated 2025-11-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bictegravir

Tablets administered orally without regard to food

DRUG

Lenacapavir

Tablets administered orally without regard to food

DRUG

B/F/TAF

Tablets administered orally without regard to food

DRUG

Placebo to match B/F/TAF

Tablets administered orally without regard to food

DRUG

Placebo to match BIC/LEN

Tablets administered orally without regard to food

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2025-10-27
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Dominican Republic
  • Germany
  • Italy
  • Japan
  • Mexico
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333808 on ClinicalTrials.gov