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Integrase Strand Transfer Inhibitor

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

Key

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to week 24

Summary

This trial aims to test two new drugs, GS-1720 and GS-4182, for treating HIV-1 infection in people who have not received treatment before. The study will compare these drugs

Who is the study for?

This trial is for people with HIV-1 who haven't been treated before. They must have an HIV-1 RNA count of at least 500 copies/mL and can have used pre-exposure or postexposure prophylaxis up to a month before screening.

What is being tested?

The study tests GS-1720, an experimental oral drug, and GS-4182, its prodrug form, against Biktarvy (B/F/TAF), the current standard treatment. It's in two phases: Phase 2 checks efficacy at Week 24; Phase 3 compares a fixed-dose combo tablet regimen to Biktarvy at Week 48.

What are the potential side effects?

Possible side effects are not detailed here but typically include reactions similar to other antiretroviral drugs such as nausea, headache, fatigue, and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to week 24

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

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, as Applicable

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

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

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

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

Participants will receive a 1-day loading dose of GS-1720/GS-4182 FDC on Day 1. Thereafter, participants will receive GS-1720/GS-4182 FDC tablets weekly + PTM B/F/TAF once daily. 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 continue to receive GS-1720/GS-4182 FDC weekly while PTM B/F/TAF will be discontinued. Phase 3 Treatment Group 2 will switch to receive GS-1720/GS-4182 FDC tablets weekly. Participants in Treatment Group 2 will also receive a 1-day loading dose of GS-1720/GS-4182 FDC on Extension Phase Day 1. Participants who choose to enter the Phase 3 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 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 (650/300 mg) weekly. Phase 2 Treatment Group 2 will receive a loading dose of GS-1720/GS-4182 FDC (1300 mg/600 mg) on Extension Phase Day 1, then GS-1720/GS-4182 FDC (650/300 mg) 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: B/F/TAF (Treatment Group 2)Active Control1 Intervention

Participants will receive B/F/TAF (50/200/25 mg) daily for at least 48 weeks.

Group VI: Phase 3: B/F/TAF + PTM GS-1720/GS-4182 FDC (Treatment Group 2)Active Control2 Interventions

Participants will receive oral B/F/TAF daily along with PTM GS-1720/GS-4182 FDC weekly for at least 96 weeks. Additionally, participants will receive a 1-day loading dose of PTM GS-1720/GS-4182 on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GS-1720

2022

Completed Phase 1

~50

0 / 1Eligibility criteria met