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Anti-retroviral

GS-1720 + GS-4182 for HIV

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

Receiving BVY for ≥ 24 weeks prior to screening

Be older than 18 years old

Must not have

Prior use of, or exposure to LEN, GS-1720, or GS-4182

Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to week 48

Summary

This trial aims to study two experimental drugs, GS-1720 and GS-4182, and compare them with the current standard HIV treatment, BVY. The study will determine if the combination of

Who is the study for?

This trial is for people with HIV who have their virus levels under control. Participants should be currently taking and responding well to standard HIV treatment. The study will exclude individuals based on certain medical conditions or treatments that could interfere with the trial.

What is being tested?

The study is testing new drugs, GS-1720 and GS-4182, alone and in combination, against a current standard HIV treatment (Biktarvy). It's designed to see if these new drugs are safe and effective when taken weekly by people whose HIV is already suppressed.

What are the potential side effects?

Potential side effects aren't specified here but may include typical reactions seen with antiretroviral therapy such as nausea, headaches, fatigue, or more serious effects like liver toxicity or drug resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been taking BVY for at least 24 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously used LEN, GS-1720, or GS-4182.

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I have used long-acting HIV drugs like injectable cabotegravir or rilpivirine.

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My HIV treatment with INSTI drugs failed to control the virus.

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My HIV treatment is not working due to specific resistance mutations.

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My kidney function is reduced, with a filtration rate under 60 mL/min.

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I have hepatitis B.

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I have active hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Phase 2: PK Parameter: AUCtau of GS-1720 and LEN

Phase 2: PK Parameter: Ctau of GS-1720 and LEN

Phase 2: PK Parameter: Tmax of GS-1720 and LEN

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Phase 3: GS-1720/GS-4182 FDC + Placebo to Match (PTM) BVY (Treatment Group 1)Experimental Treatment2 Interventions

Participants who have been virologically suppressed on BVY will switch from BVY to GS-1720/GS-4182 FDC tablets weekly + placebo-to-match (PTM) BVY once daily. In addition, participants will receive a 1-day loading dose regimen of GS-1720/GS-4182 FDC on Day 1. Participants will receive treatment for at least 96 weeks.

Group II: Phase 3 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC)Experimental Treatment1 Intervention

After the end of blinded treatment, Phase 3 participants will be given the option to participate in the Extension Phase. Phase 3 Treatment Group 1 will switch to GS-1720/GS-4182 FDC weekly. Phase 3 Treatment Group 2 will receive a 1-day loading dose of GS-1720/GS-4182 FDC on Extension Phase Day 1, then GS-1720/GS-4182 FDC weekly. Participants who choose to enter the Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.

Group III: Phase 2: GS-1720 + GS-4182 (Treatment Group 1)Experimental Treatment2 Interventions

Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will switch to GS-1720 (650 mg tablet) and GS-4182 (300 mg tablet) coadministered. Participants will receive a 1-day loading dose of GS-1720 (1300 mg) and GS-4182 (600 mg) on Day 1. Thereafter, participants will take weekly doses of single agent GS-1720 (650 mg) and GS-4182 (300 mg) coadministered for at least 48 weeks.

Group IV: Phase 2 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC)Experimental Treatment1 Intervention

At the end of the randomized treatment, Phase 2 participants will be given the option to participate in the Extension Phase. Phase 2 Treatment Group 1 will switch to GS-1720/GS-4182 FDC weekly. Phase 2 Treatment Group 2 will receive a loading dose of GS-1720/GS-4182 FDC on Extension Phase Day 1 then, GS-1720/GS-4182 FDC weekly. Participants who choose to enter the Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.

Group V: Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2)Active Control1 Intervention

Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will continue receiving BVY daily for at least 48 weeks.

Group VI: Phase 3: BVY Placebo to Match GS-1720/GS-4182 FDC + BVY (Treatment Group 2)Active Control2 Interventions

Participants who have been virologically suppressed on BVY will continue receiving oral BVY daily. In addition, participants will receive a 1-day loading dose of PTM GS-1720/GS-4182 on Day 1 and weekly PTM thereafter. Participants will receive treatment for at least 96 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GS-1720

2022

Completed Phase 1

~50

0 / 8Eligibility criteria met