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Integrase Inhibitor

Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF for HIV (ARTISTRY-2 Trial)

Q: At how many distinct sites is this research study currently underway?

Enrollment for this research includes sites such as Southhampton Community Healthcare, Inc. in Saint Louis, Ruane Medical and Clinical Research Institute in Los Angeles, and Therafirst Medical Center in Fort Lauderdale among 7 additional locations.

Q: Are there any available positions for patients in this ongoing clinical trial?

According to the details available on clinicaltrials.gov, this study is actively pursuing eligible candidates. The trial was initially uploaded on March 25th, 2024, and last revised on April 15th of the same year.

Q: What is the current number of individuals being recruited for participation in this clinical investigation?

To commence the trial, 546 eligible participants are needed. The sponsor, Gilead Sciences, will oversee operations across multiple locations such as Southhampton Community Healthcare in Saint Louis and Ruane Medical and Clinical Research Institute in Los Angeles.

Q: Is the combination of Bictegravir and Lenacapavir along with a regimen of PTM B/F/TAF at doses 75/50 mg FDA approved for Treatment Group 1?

When evaluating the safety of Treatment Group 1, consisting of Bictegravir (BIC)/ Lenacapavir (LEN) at a dose of 75/50 mg in combination with PTM B/F/TAF, our team assigns a rating of 3. This decision is based on the trial being in Phase 3 and having existing data supporting effectiveness along with robust safety records from multiple iterations.

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 week 96

Awards & highlights

ARTISTRY-2 Trial 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.Check my eligibility

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.See study design

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.

ARTISTRY-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48

Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

+4 more

ARTISTRY-2 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

~50

Lenacapavir

2018

Completed Phase 1

~60

B/F/TAF

2016

Completed Phase 4

~4900

Placebo to match B/F/TAF

2018

Completed Phase 3

~250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

847,716 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,147 Total Patients Enrolled

Frequently Asked Questions

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

At how many distinct sites is this research study currently underway?

"Enrollment for this research includes sites such as Southhampton Community Healthcare, Inc. in Saint Louis, Ruane Medical and Clinical Research Institute in Los Angeles, and Therafirst Medical Center in Fort Lauderdale among 7 additional locations."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"According to the details available on clinicaltrials.gov, this study is actively pursuing eligible candidates. The trial was initially uploaded on March 25th, 2024, and last revised on April 15th of the same year."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"To commence the trial, 546 eligible participants are needed. The sponsor, Gilead Sciences, will oversee operations across multiple locations such as Southhampton Community Healthcare in Saint Louis and Ruane Medical and Clinical Research Institute in Los Angeles."

Answered by AI

Is the combination of Bictegravir and Lenacapavir along with a regimen of PTM B/F/TAF at doses 75/50 mg FDA approved for Treatment Group 1?

"When evaluating the safety of Treatment Group 1, consisting of Bictegravir (BIC)/ Lenacapavir (LEN) at a dose of 75/50 mg in combination with PTM B/F/TAF, our team assigns a rating of 3. This decision is based on the trial being in Phase 3 and having existing data supporting effectiveness along with robust safety records from multiple iterations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06333808.

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