Study Details

OVERVIEW

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

PROTOCOL SUMMARY

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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

HIV-1-infection

Gender

N/A

Date

October 2024 - January 2029

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

Product

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

Eligibility Information

Inclusion 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.

Exclusion Criteria

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

Locations

Locations (14)

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States, 90502

Mills Clinical Research

West Hollywood, California, United States, 90046

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States, 33016

Orlando Immunology Center

Orlando, Florida, United States, 32803

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33407

Mercer University, Department of Internal Medicine

Macon, Georgia, United States, 31201

St Hope Foundation, Inc.

Bellaire, Texas, United States, 77401

Prism Health North Texas, Aids Arms

Dallas, Texas, United States, 75208

North Texas Infectious Diseases Consultants, PA

Dallas, Texas, United States, 75246

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

HOPE Clinical Research

San Juan, Puerto Rico, 00909

Proyecto ACTU

San Juan, Puerto Rico, 00935

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