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Capsid Inhibitor
Combination Antiretroviral Therapy for HIV
Phase 2
Waitlist Available
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 end of study (up to approximately 6 years)
Awards & highlights
Study Summary
This trial tests a combination of HIV treatments for effectiveness, safety, and tolerability in adults with HIV-1.
Who is the study for?
This trial is for adults with HIV-1 who've had a stable viral load under 50 copies/mL for at least a year, no significant resistance to their current ART regimen, and CD4+ T-cell count over 200 cells/μL. They shouldn't have hepatitis B or C infections, require ongoing immunosuppression, or have had Stage 3 HIV illnesses.Check my eligibility
What is being tested?
The study tests the effectiveness of switching from standard oral ART to a new regimen combining lenacapavir (LEN) with two antibodies, teropavimab and zinlirvimab. It measures if participants maintain low HIV RNA levels (<50 copies/mL) after this switch.See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites for LEN and infusion-related reactions for bNAbs. Other common side effects can be fatigue, headache, gastrointestinal issues like nausea or diarrhea, and possible changes in liver enzymes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to end of study (up to approximately 6 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of study (up to approximately 6 years)
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 Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-defined Snapshot Algorithm
Secondary outcome measures
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 26
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 52
PK Parameter: AUClast for GS-5423, GS-2872, and LEN
+12 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose BExperimental Treatment4 Interventions
Participants will receive oral LEN 600mg, subcutaneous (SC) LEN 927 mg, teropavimab Dose A, and zinlirvimab Dose B on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. The last treatment regimen will include SC LEN + teropavimab Dose A + zinlirvimab Dose B.
Group II: Randomized Phase: Antiretroviral Therapy (ART)Experimental Treatment1 Intervention
Participants will continue their baseline oral ART through Week 52.
Group III: Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose BExperimental Treatment3 Interventions
At Week 52, participants who receive the study drug of LEN, teropavimab, zinlirvimab, and complete study through Week 52 with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL will be given the option to participate in the study extension phase, where they will continue to receive their randomized study drugs treatment regimen until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years.
Group IV: Extension Phase: ARTExperimental Treatment4 Interventions
Participants who complete study through Week 52 with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound (VR) throughout the randomized phase of the study will be given the option to participate in the extension phase and receive the study drugs of LEN, teropavimab, and zinlirvimab at the dose specified for randomized phase until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years. Treatment with study drug will begin at Week 52 and at that time the baseline oral ART will be discontinued.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antiretroviral Therapy
2018
N/A
~160
Teropavimab
2021
Completed Phase 1
~40
Zinlirvimab
2021
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,758 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,752 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have hepatitis B.My virus is sensitive to teropavimab and zinlirvimab based on recent tests.I changed my HIV medication more than 28 days ago, not due to treatment failure.I have been on a stable HIV medication regimen of up to 2 drug classes for over a year.My HIV treatment is working without significant resistance, except for some minor exceptions.I am on continuous medication to suppress my immune system due to another health condition.I have had a serious infection or illness because of advanced HIV.My HIV treatment is working without significant resistance, except for some minor exceptions.My virus is sensitive to teropavimab and zinlirvimab.I've been on a stable HIV treatment with up to 2 drug classes for over a year.
Research Study Groups:
This trial has the following groups:- Group 1: Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose B
- Group 2: Randomized Phase: Antiretroviral Therapy (ART)
- Group 3: Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose B
- Group 4: Extension Phase: ART
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this research project?
"According to the clinicaltrial.gov website, this medical trial is actively seeking participants at this moment in time. This initiative was initially posted on May 15th 2023 and was recently amended on May 30th 2023."
Answered by AI
Is the age requirement for this experiment restricted to adults?
"In order to be eligible for this research, potential participants must be between ages 18 and 65. Those younger than 18 years old have access to 284 associated trials while those over the age of 65 can explore 883 options."
Answered by AI
Are there a substantial number of medical centers experimenting with this trial in Canada?
"This trial is being conducted through Optimus Medical Group in San Francisco, Can Community Health Care in Fort Lauderdale, Midway Immunology and Research Center in Fort Pierce, as well as 11 other medical sites."
Answered by AI
Has the FDA sanctioned Randomized Phase: Treatment Group 2 - LEN + Teropavimab Dose C + Zinlirvimab Dose D?
"Our team at Power gauged the safety of Randomized Phase: Treatment Group 2 - LEN + Teropavimab Dose C + Zinlirvimab Dose D to be a 2, as this is currently in its second phase and there are data confirming safety but not efficacy."
Answered by AI
Who meets the criteria to be part of this medical experiment?
"This clinical trial needs to enlist 125 people living with HIV, aged between 18 and 65. Furthermore, they must meet the pre-determined criteria: stability on a two drug class ART regimen for at least one year prior to screening (with accepted exceptions); no significant documented historical resistance towards current antiretroviral treatments; plasma viral load of less than 50 copies/mL upon assessment; an undetectable viral load status over the 12 months before enrollment; proviral genotypic sensitivity towards both teropavimab and zinlirvimab from GS-US 536 5816 within 24 months prior to testing or during"
Answered by AI
Who else is applying?
What site did they apply to?
The Crofoot Research Center, INC
What portion of applicants met pre-screening criteria?
Met criteria
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