Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

Description

The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), 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 in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.

Conditions

HIV-1-infection

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Study Overview

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Study Details

Study overview

The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), 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 in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.

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 Treatment-Naive People With HIV-1

Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

Condition
HIV-1-infection
Intervention / Treatment

-

Contacts and Locations

West Hollywood

Mills Clinical Research, West Hollywood, California, United States, 90046

DeLand

Midland Florida Clinical Research Center, LLC, DeLand, Florida, United States, 32720

Fort Pierce

Midway Immunology and Research Center, Fort Pierce, Florida, United States, 34982

West Palm Beach

Triple O Research Institute, P.A., West Palm Beach, Florida, United States, 33407

Macon

Mercer University, Department of Internal Medicine, Macon, Georgia, United States, 31201

Bellaire

St Hope Foundation, Inc., Bellaire, Texas, United States, 77401

Dallas

Prism Health North Texas, Aids Arms, Dallas, Texas, United States, 75208

Dallas

North Texas Infectious Diseases Consultants, PA, Dallas, Texas, United States, 75246

Fort Worth

Texas Centers for Infectious Disease Associates, Fort Worth, Texas, United States, 76104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * HIV-1 RNA ≥ 500 copies/mL at screening.
  • * Antiretroviral (ARV) treatment-naive, except the use of oral pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or F/TAF, up to 1 month prior to screening.
  • * Prior use of any long acting parenteral antiretrovirals (ARVs) such as monoclonal antibodies, broadly neutralizing antibodies targeting HIV-1, LEN, injectable cabotegravir (including oral cabotegravir lead-in), and/or injectable rilpivirine.
  • * Documented resistance to the integrase strand-transfer inhibitor class, specifically, resistance-associated mutations E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
  • * Any of the following laboratory values at screening:
  • 1. CD4 cell count \< 200 cells/mm3 at screening.
  • 2. Estimated glomerular filtrations arate \< 60 mL/min according to the Modification of Diet in Renal Disease formula.
  • 3. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) \> 1.5 × upper limit of normal (ULN).
  • 4. Direct bilirubin \> 1.5 × ULN.
  • 5. Platelets count \< 50,000 cells/mm3.
  • 6. Hemoglobin \< 8.0 g/dL.
  • * Active or occult hepatitis B virus infection.
  • * Active hepatitis C virus infection.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2030-08