NCT04811040

Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir (LEN).

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Oral Lenacapavir	Tablets administered without regard to food
DRUG	Subcutaneous Lenacapavir	Administered in the abdomen via subcutaneous injections
DRUG	Teropavimab	Administered intravenously
DRUG	Zinlirvimab	Administered intravenously

Timeline

• Start date: 2021-04-08
• Primary completion: 2022-06-09
• Completion: 2023-10-26
• First posted: 2021-03-23
• Last updated: 2025-01-27
• Results posted: 2025-01-27

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study