This study is in progress, not accepting new patients

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

a study on HIV/AIDS

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

An 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

Keywords

HIV-1-Infection, Tenofovir, Emtricitabine, Emtricitabine tenofovir alafenamide, Bictegravir/emtricitabine/tenofovir alafenamide, GS-1720/GS-4182 FDC

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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/mm3 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/mm3
    • 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.

Locations

  • UCSF Division of HIV, Infectious Diseases & Global Medicine
    San Francisco California 94110 United States
  • Mills Clinical Research
    Los Angeles California 90069 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT06544733
Phase
Phase 2/3 HIV/AIDS Research Study
Study Type
Interventional
Participants
Expecting 675 study participants
Last Updated