A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

NCT05729568 · tracked via the Priya Life Science Australia tracker

Sponsor

Gilead Sciences

Phase

Phase 2

Started

2023-05-15

Last updated

2026-04-27

Condition(s) studied

HIV-1 Infection

Investigational drug(s) / intervention(s)

Teropavimab →Zinlirvimab →Lenacapavir Tablet →Lenacapavir Injection →Antiretroviral Therapy

Teropavimab: Administered intravenously

Zinlirvimab: Administered intravenously

Lenacapavir Tablet: Administered orally

Lenacapavir Injection: Administered subcutaneously

Antiretroviral Therapy: Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide.

Study summary

The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection.

The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Key Inclusion Criteria: * On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed. * No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q). * Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL at screening visit 2. * Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable. * Proviral phenotypic sensitivity to both teropavimab and zinlirvimab by the PhenoSense Assay (Monogram Biosciences). * Screening clusters of differentiation 4 (CD4)+ T-cell count ≥ 200 cells/μL at screening visit 2. Key Exclusion Criteria: * Comorbid condition requiring ongoing immunosuppression. * Hepatitis C virus (HCV) antibody positive and HCV RNA detectable. * Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2. * History of opportunistic infection or illness indicative of Stage 3 HIV disease. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm — Week 26
Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.

Trial sites (34)

Facility	City	Region
Ruane Clinical Research Group, Inc.	Los Angeles	California
Mills Clinical Research	Los Angeles	California
UC San Diego (UCSD) AntiViral Research Center (AVRC)	San Diego	California
Optimus Medical Group	San Francisco	California
University of Colorado Clinical and Translational Research Center	Aurora	Colorado
Yale University; School of Medicine; AIDS Program	New Haven	Connecticut
Georgetown University Medical Center	Washington D.C.	District of Columbia
Midland Florida Clinical Research Center, LLC	DeLand	Florida
Can Community Health Care	Fort Lauderdale	Florida
Midway Immunology and Research Center	Ft. Pierce	Florida
Orlando Immunology Center	Orlando	Florida
Triple O Research Institute, P.A.	West Palm Beach	Florida
Emory University Hospital Midtown Infectious Disease Clinic	Atlanta	Georgia
Infectious Disease Specialists of Atlanta	Decatur	Georgia
Southhampton Healthcare, Inc	St Louis	Missouri
AXCES Research Group, LLC	Albuquerque	New Mexico
Montefiore Medical Center	The Bronx	New York
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
Duke University Health Center	Durham	North Carolina
Regional Center for Infectious Disease Research	Greensboro	North Carolina
The Brody School of Medicine at East Carolina University	Greenville	North Carolina
Rosedale Health and Wellness	Huntersville	North Carolina
Prisma Health - Clinical Research Unit	Columbia	South Carolina
St Jude Children's Research Hospital	Memphis	Tennessee
Central Texas Clinical Research	Austin	Texas
AIDS Arms, Inc. DBA Prism Health North Texas	Dallas	Texas
AXCES Research Group, LLC	El Paso	Texas
The Crofoot Research Center, INC	Houston	Texas
Clinical Alliance for Research & Education, Infectious Diseases LLC (CARE-ID)	Annandale	Virginia
East Sydney Doctors	Darlinghurst	New South Wales
Holdsworth House Medical Practice	Sydney	New South Wales
Alfred Hospital	Melbourne	Victoria
Maple Leaf Research/Maple Leaf Medical Clinic	Toronto	Canada
Clinical Research Puerto Rico	San Juan	Puerto Rico

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Other trials for the same condition

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) Active, not recruiting

Pomalidomide as an Immune-enhancing Agent for the Control of HIV Active, not recruiting

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051) Active, not recruiting

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) Active, not recruiting

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05729568 on ClinicalTrials.gov ↗ ← All trials in Australia