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ACTIVE NOT RECRUITING Phase 2

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

NCT06544733 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG GS-1720
  • DRUG GS-4182
  • DRUG Bictegravir/emtricitabine/tenofovir alafenamide
  • DRUG GS-1720/GS-4182 FDC
  • DRUG Placebo to Match BVY

Study Locations (20)

Florida

  • Midland Florida Clinical Research Center, LLC — DeLand
  • CAN Community Health — Fort Lauderdale
  • Midway and Immunology Research Center — Ft. Pierce
  • AIDS Healthcare Foundation - The Kinder Medical Group — Miami
  • Floridian Clinical Research — Miami Lakes
  • Orlando Immunology Center — Orlando
  • CAN Community Health — Sarasota
  • Triple O Research Institute, P.A. — West Palm Beach

California

  • Pacific Oaks Medical Group — Beverly Hills
  • Ruane Clinical Research Group — Los Angeles
  • Mills Clinical Research — Los Angeles
  • BIOS Clinical Research — Palm Springs
  • UCSF Division of HIV, Infectious Diseases & Global Medicine — San Francisco
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance

Georgia

  • Metro Infectious Disease Consultants, P.L.L.C. — Decatur
  • Mercer University, Department of Internal Medicine — Macon
  • Chatham County Health Department — Savannah

Alabama

  • UAB 1917 Research Clinic — Birmingham

District of Columbia

  • Georgetown University Medical Center — Washington D.C.

Michigan

  • Be Well Medical Center — Berkley

Trial Details

FieldValue
Enrollment Target 675 participants
Start Date 2024-08-20
Est. Completion 2029-06
Phase Phase 2

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06544733

The ClinicalTrials.gov registry entry for NCT06544733 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 675 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HIV-1-Infection appearing as the primary indexed condition, and to 5 interventions — of which GS-1720 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06544733 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06544733 about?

NCT06544733 is a clinical study titled "Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed". 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...

What is the current status of trial NCT06544733?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 675 participants. The study started on 2024-08-20. Estimated completion is 2029-06.

What conditions does trial NCT06544733 study?

This clinical trial studies the following conditions: HIV-1-Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06544733?

The interventions under investigation include: GS-1720 (DRUG), GS-4182 (DRUG), Bictegravir/emtricitabine/tenofovir alafenamide (DRUG), GS-1720/GS-4182 FDC (DRUG), Placebo to Match BVY (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06544733?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06544733 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial