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Integrase Inhibitor

Bictegravir + Lenacapavir for HIV (ARTISTRY-2 Trial)

Phase 3
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial aims to compare the effects of switching to a new combination drug (BIC/LEN) versus continuing the current therapy (B/F/TAF) in HIV patients who have the virus under control

Who is the study for?
This trial is for people with HIV-1 who have been successfully treated with Biktarvy (B/F/TAF) for at least 6 months, have undetectable viral loads (<50 copies/mL), and adequate kidney function. They must not have resistance to the drugs Bictegravir or Tenofovir Alafenamide.
What is being tested?
The study compares a new combination of HIV medications, Bictegravir/Lenacapavir (BIC/LEN), against the current therapy of Biktarvy (B/F/TAF). It aims to see if switching treatments maintains virus suppression in people with HIV.
What are the potential side effects?
Potential side effects may include gastrointestinal issues, headaches, fatigue, and allergic reactions. Specific side effects related to Bictegravir or Lenacapavir will be monitored closely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LENExperimental Treatment4 Interventions
Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.
Group II: Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAFExperimental Treatment3 Interventions
Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bictegravir
2015
Completed Phase 1
~230
B/F/TAF
2016
Completed Phase 4
~5170
Lenacapavir
2018
Completed Phase 1
~60
Placebo to match B/F/TAF
2018
Completed Phase 3
~250

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Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,098 Previous Clinical Trials
859,923 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
351 Previous Clinical Trials
188,814 Total Patients Enrolled
~364 spots leftby Dec 2025
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