Study to Evaluate the Safety and Efficacy of GS-5423 and GS-2872 in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

Status:Ongoing
Phase:I
Principal Investigator(s):
Objective:The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) GS-5423 and GS-2872 in combination with the HIV capsid inhibitor lenacapavir (LEN).  Last updated May 17, 2022
Prevention Option(s):Combination Prevention
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Lenacapavir (LEN), GS-5423, GS-2872 Dose C Participants will begin treatment by receiving LEN Dose A + LEN Dose B + GS-5423 + GS-2872 Dose C followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + GS-5423 + GS-2872 Dose C. Drug: Oral Lenacapavir Tablets administered without regard to food Other Name: GS-6207 Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections Other Name: GS-6207 Drug: GS-5423 Administered intravenously Other Name: 3BNC117-LS Drug: GS-2872 Administered intravenously Other Name: 10-1074-LS
Mode of DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: LEN, GS-5423, GS-2872 Dose D Participants will begin treatment by receiving LEN Dose A + LEN Dose B + GS-5423 + GS-2872 Dose D followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + GS-5423 + GS-2872 Dose D. Drug: Oral Lenacapavir Tablets administered without regard to food Other Name: GS-6207 Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections Other Name: GS-6207 Drug: GS-5423 Administered intravenously Other Name: 3BNC117-LS Drug: GS-2872 Administered intravenously Other Name: 10-1074-LS
Mode of DeliverySubcutaneous, Tablet
ARMsExperimental
Official Code: NCT04811040
Trial Sponsors: Gilead
Start Date
End Date
April 8, 2021
December 31, 2023
Enrollment:50
Age range: 18 Years ↔ 65 Years
Population:Cisgender Men, Cisgender Women