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Integrase Strand Transfer Inhibitor

Bictegravir + Lenacapavir for HIV (ARTISTRY-1 Trial)

Phase 2 & 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
Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy
No documented or suspected resistance to bictegravir (BIC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to week 24
Awards & highlights

ARTISTRY-1 Trial Summary

This trial will look at whether switching to a new antiviral regimen of bictegravir and lenacapavir is more effective than continuing on a stable baseline regimen in people with human immunodeficiency virus who are virologically suppressed.

Who is the study for?
This trial is for people with HIV-1 who have been successfully treated but are on complex regimens, including multiple pills or injections plus oral meds. They should have no resistance to bictegravir, stable kidney function (not on dialysis), and undetectable HIV levels for at least 6 months. It's not for those with active tuberculosis, prior lenacapavir use, or chronic hepatitis B.Check my eligibility
What is being tested?
The study compares the effects of switching to a new regimen of bictegravir plus lenacapavir versus continuing current therapy in Phase 2. In Phase 3, it looks at a fixed-dose combination of these drugs against current treatments in people living with HIV.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal issues like nausea and diarrhea, possible allergic reactions, liver enzyme changes indicating liver health concerns, fatigue, headache and other common drug-related adverse events.

ARTISTRY-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidneys work well enough, and I don't need dialysis.
Select...
My condition does not resist bictegravir treatment.
Select...
I have been on a complex HIV medication plan for at least 6 months.

ARTISTRY-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Secondary outcome measures
Phase 2: Change From Baseline in CD4 Cell Count at Week 24
Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State
Structure of lenticular fasciculus
+9 more

Side effects data

From 2015 Phase 1 trial • 23 Patients • NCT02275065
25%
Blood creatine phosphokinase increased
25%
Upper respiratory tract infection
25%
Diarrhoea
25%
Musculoskeletal pain
25%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bictegravir 5 mg
Bictegravir 25 mg
Bictegravir 100 mg
Placebo
Bictegravir 50 mg

ARTISTRY-1 Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)Experimental Treatment1 Intervention
Participants will switch from their SBR to a regimen of BIC/LEN 75 mg/50 mg FDC. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1 up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
Group II: Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mgExperimental Treatment2 Interventions
Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg fixed dose combination (FDC).
Group III: Phase 2: BIC 75 mg + LEN 50 mgExperimental Treatment2 Interventions
Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1 up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
Group IV: Phase 2: Stable Baseline Regimen (SBR)Active Control1 Intervention
Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
Group V: Phase 3: Stable Baseline RegimenActive Control1 Intervention
Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bictegravir
2015
Completed Phase 1
~50
Lenacapavir
2018
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,082 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,076 Total Patients Enrolled

Media Library

Bictegravir (Integrase Strand Transfer Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05502341 — Phase 2 & 3
HIV Research Study Groups: Phase 2: Stable Baseline Regimen (SBR), Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC), Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg, Phase 2: BIC 75 mg + LEN 50 mg, Phase 3: Stable Baseline Regimen
HIV Clinical Trial 2023: Bictegravir Highlights & Side Effects. Trial Name: NCT05502341 — Phase 2 & 3
Bictegravir (Integrase Strand Transfer Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05502341 — Phase 2 & 3
HIV Patient Testimony for trial: Trial Name: NCT05502341 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum amount of people who can join this clinical trial?

"In order to successfully complete this clinical trial, 671 patients must be recruited. The trial is being conducted at multiple sites, such as Saint Michael's Medical Center in Newark, New jersey and Clinique Medicale du Quartier Latin in Montreal, Florida."

Answered by AI

Are investigators still enrolling patients in this clinical trial?

"The latest information available on clinicaltrials.gov reveals that this study is currently looking for participants. This research was first made public on August 16th, 2020 and was last edited on November 3rd, 2020."

Answered by AI

Are there several facilities running this clinical trial in North America?

"This trial is being conducted out of multiple hospitals and medical centres including Saint Michael's Medical Center in Newark, New jersey, Clinique Medicale du Quartier Latin in Montreal, Florida, and Midland Florida Clinical Research Center, LLC in DeLand, California."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want to ensure that this drug can reduce levels and get to an undetectable level.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How much is the compensation?
PatientReceived no prior treatments
~335 spots leftby Jan 2026