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Bictegravir + Lenacapavir for HIV (ARTISTRY-1 Trial)
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.
ARTISTRY-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 1 trial • 23 Patients • NCT02275065ARTISTRY-1 Trial Design
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Who is running the clinical trial?
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- My kidneys work well enough, and I don't need dialysis.I have chronic hepatitis B.I do not have an active tuberculosis infection.My kidneys work well enough, and I don't need dialysis.I have previously used or been exposed to lenacapavir.My condition does not resist bictegravir treatment.My HIV treatment is complex, involving multiple pills or injections.I have been on a complex HIV medication plan for at least 6 months.My HIV treatment includes more than one type of medication.Plasma HIV-1 RNA levels < 50 copies/mL at screening.My condition does not resist bictegravir treatment.My HIV-1 levels have been under control for at least 6 months.I'm sorry, but I need more context to properly summarize this criterion. Can you please provide more information or context for me to work with?
- Group 1: Phase 2: Stable Baseline Regimen (SBR)
- Group 2: Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)
- Group 3: Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg
- Group 4: Phase 2: BIC 75 mg + LEN 50 mg
- Group 5: Phase 3: Stable Baseline Regimen
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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