Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed (NCT06544733) — USA Trial Details

Condition(s) studied

HIV-1-Infection

Investigational drug(s) / intervention(s)

LepetegravirLenacapavir pacfosacilPlacebo to Match BVYBictegravir/emtricitabine/tenofovir alafenamide →Lepetegravir/Lenacapavir pacfosacil FDCPlacebo to Match GS1720/GS-4182 FDC

Lepetegravir: Tablets administered orally without regard to food

Lenacapavir pacfosacil: Tablets administered orally without regard to food

Placebo to Match BVY: Tablets administered orally without regard to food

Bictegravir/emtricitabine/tenofovir alafenamide: Tablets administered orally without regard to food

Lepetegravir/Lenacapavir pacfosacil FDC: Tablets administered orally without regard to food

Placebo to Match GS1720/GS-4182 FDC: Tablets administered orally without regard to food

Study summary

The goal of this clinical study is to learn more about the experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of lepetegravir and lenacapavir pacfosacil 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 lepetegravir in combination with lenacapavir pacfosacil 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 lepetegravir /lenacapavir pacfosacil Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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, lepetegravir, or lenacapavir pacfosacil. * 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.

Primary outcome measure(s)

Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-defined Snapshot Algorithm — Week 24
Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm — Week 48

Trial sites (39)

Facility	City	Region
UAB 1917 Research Clinic	Birmingham	Alabama
Pacific Oaks Medical Group	Beverly Hills	California
Ruane Clinical Research Group	Los Angeles	California
Mills Clinical Research	Los Angeles	California
BIOS Clinical Research	Palm Springs	California
UCSF Division of HIV, Infectious Diseases & Global Medicine	San Francisco	California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
Georgetown University Medical Center	Washington D.C.	District of Columbia
Midland Florida Clinical Research Center, LLC	DeLand	Florida
CAN Community Health	Fort Lauderdale	Florida
Midway and Immunology Research Center	Ft. Pierce	Florida
AIDS Healthcare Foundation - The Kinder Medical Group	Miami	Florida
Floridian Clinical Research	Miami Lakes	Florida
Orlando Immunology Center	Orlando	Florida
CAN Community Health	Sarasota	Florida
Triple O Research Institute, P.A.	West Palm Beach	Florida
Metro Infectious Disease Consultants, P.L.L.C.	Decatur	Georgia
Mercer University, Department of Internal Medicine	Macon	Georgia
Chatham County Health Department	Savannah	Georgia
Be Well Medical Center	Berkley	Michigan
KC CARE Health Center	Kansas City	Missouri
Saint Michael's Medical Center	Newark	New Jersey
AXCES Research Group, LLC	Santa Fe	New Mexico
NewYork-Presbyterian Queens	Flushing	New York
NYU Langone Health Vaccine Center	New York	New York
Rosedale Health and Wellness	Huntersville	North Carolina
Central Texas Clinical Research	Austin	Texas
St Hope Foundation, Inc.	Bellaire	Texas
Prism Health North Texas, Oak Cliff Health Center	Dallas	Texas
North Texas Infectious Diseases Consultants, PA	Dallas	Texas
AXCES Research Group, LLC	El Paso	Texas
Texas Centers for Infectious Disease Associates	Fort Worth	Texas
The Crofoot Research Center, INC.	Houston	Texas
DCOL Center for Clinical Research	Longview	Texas
Peter Shalit, MD	Seattle	Washington
Centro Ararat, Inc.	San Juan	PR
Clinical Research Puerto Rico	San Juan	PR
HOPE Clinical Research	San Juan	PR
Proyecto ACTC	San Juan	PR

On this site

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