Suspended

WONDERS1GS-1720 and GS-4182 for HIV-1 in Virologically Suppressed Patients

What is being tested

GS-1720

+ GS-4182

+ Placebo to Match BVY

Drug

Who is being recruted

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: August 2024

See protocol details

Summary

Principal SponsorGilead Sciences

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 20, 2024

Actual date on which the first participant was enrolled.

This clinical study aims to explore new treatment options for individuals living with HIV-1 who are currently managing their condition well with medication. The study focuses on two experimental drugs, GS-1720 and GS-4182, and compares their effectiveness and safety against a commonly used HIV treatment known as Biktarvy. The goal is to determine if this new combination of medications can provide a safe and effective alternative for people who have successfully suppressed the virus in their bodies, offering them potentially improved treatment options in the future. Participants in this study will switch from their regular medication to a once-a-week oral regimen of GS-1720 and GS-4182, or they will continue with Biktarvy. The study will assess how well the new combination controls the HIV virus after 24 weeks in the initial phase and after 48 weeks in the later phase. This involves regular monitoring to ensure the virus remains suppressed and to check for any side effects or health changes. The study's findings could lead to more convenient treatment schedules and possibly enhance the quality of life for those living with HIV-1.

Official TitleAn Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1

NCT06544733

Principal SponsorGilead Sciences

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

675 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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 II

Experimental

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 III

Active Comparator

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

Group IV

Active Comparator

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.

Group 5

Experimental

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 6

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 39 locations

Suspended

UAB 1917 Research Clinic

Birmingham, United StatesOpen UAB 1917 Research Clinic in Google Maps

Suspended

Pacific Oaks Medical Group

Beverly Hills, United States

Suspended

Ruane Clinical Research Group

Los Angeles, United States

Suspended

Mills Clinical Research

Los Angeles, United States

Suspended39 Study Centers