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The trial is taking place at:
T

The Crofoot Research Center, Inc. | Houston, TX

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Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

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Gilead Sciences

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

HIV-1-Infection

Treatments

Drug: Placebo to Match BVY
Drug: Placebo to Match GS1720/GS-4182 FDC
Drug: GS-4182
Drug: GS-1720/GS-4182 FDC
Drug: Bictegravir/emtricitabine/tenofovir alafenamide
Drug: GS-1720

Study type

Interventional

Funder types

Industry

Identifiers

NCT06544733
2024-511054-50 (Other Identifier)
GS-US-695-6509

Details and patient eligibility

About

The goal of this clinical study is to learn more about the experimental drugs GS-1720 and GS-4182; to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection.

This study has two phases: Phase 2 and Phase 3.

The primary objectives of this study are:

Phase 2: To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24.

Phase 3: To evaluate the efficacy of switching to oral weekly GS-1720/GS-4182 Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.

Enrollment

675 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
  • Receiving BVY for ≥ 24 weeks prior to screening.

Key Exclusion Criteria:

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

  • History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.

  • Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.

  • 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.

  • Any of the following laboratory values at screening:

    • Clusters of differentiation 4 (CD4) cell count < 200 cells/mm^3 at screening
    • Glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula
    • Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN)
    • Direct bilirubin > 1.5 × ULN
    • Platelets count < 50,000 cells/mm^3
    • Hemoglobin < 8.0 g/dL
  • Active or occult hepatitis B virus (HBV) infection.

  • Active hepatitis C virus (HCV).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

675 participants in 6 patient groups

Phase 2: GS-1720 + GS-4182 (Treatment Group 1)
Experimental group
Description:
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.
Treatment:
Drug: GS-1720
Drug: GS-4182
Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2)
Active Comparator group
Description:
Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will continue receiving BVY daily for at least 48 weeks.
Treatment:
Drug: Bictegravir/emtricitabine/tenofovir alafenamide
Phase 2 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC)
Experimental group
Description:
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.
Treatment:
Drug: GS-1720/GS-4182 FDC
Phase 3: GS-1720/GS-4182 FDC + Placebo to Match (PTM) BVY (Treatment Group 1)
Experimental group
Description:
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.
Treatment:
Drug: GS-1720/GS-4182 FDC
Drug: Placebo to Match BVY
Phase 3: BVY Placebo to Match GS-1720/GS-4182 FDC + BVY (Treatment Group 2)
Active Comparator group
Description:
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:
Drug: Bictegravir/emtricitabine/tenofovir alafenamide
Drug: Placebo to Match GS1720/GS-4182 FDC
Phase 3 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC)
Experimental group
Description:
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.
Treatment:
Drug: GS-1720/GS-4182 FDC

Trial contacts and locations

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Central trial contact

Study Director; Gilead Clinical Study Information Center

Data sourced from clinicaltrials.gov

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