CAPELLA
Status:Ongoing
Phase:III, II
Principal Investigator(s):
Objective:The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people living with HIV (PLWH) with multi-drug resistance (MDR).
Last updated May 17, 2022
Prevention Option(s):Combination Prevention
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Cohort 1A Lenacapavir, Failing ARV Regimen, and OBR
Functional Monotherapy Period: Participants will receive oral lenacapavir 600 mg, 600mg, and 300 mg tablets on Days 1, 2, and 8 respectively while continuing their failing regimen (previous Antiretroviral (ARV) regimen).
Maintenance Period: At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive subcutaneous (SC) lenacapavir 927 mg and initiate an optimized background regimen (OBR) (as prescribed by the Investigator). Participants will continue to receive SC lenacapavir 927 mg once every 6 months (26 weeks).
Participants willing to continue beyond the study beyond Week 52 visit will receive SC lenacapavir every 6 months (26 weeks) starting at Week 52 visit, while continuing their OBR.
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: Failing ARV Regimen
Failing antiretroviral regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
Drug: Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
Mode of DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionPlacebo Comparator: Cohort 1B: Placebo, Lenacapavir, Failing ARV Regimen, and OBR
Cohort 1B:
Functional Monotherapy Period: Participants will receive placebo on Days 1, 2, and 8 while continuing their failing regimen.
Maintenance Period: At Day 15, participants will receive oral lenacapavir 600 mg and initiate an OBR (as prescribed by the Investigator). Participants will receive oral lenacapavir 600 mg and 300 mg at Day 16 and Day 22, respectively. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive SC lenacapavir 927 mg while continuing their optimized background regimen. Participants will continue to receive SC lenacapavir 927 mg once every 6 months (26 weeks).
Participants willing to continue beyond the study beyond Week 52 visit will receive SC lenacapavir every 6 months (26 weeks) starting at Week 52 visit, while continuing their OBR.
Mode of DeliverySubcutaneous, Tablet
ARMsPlacebo Comparator
DescriptionExperimental: Cohort 2: Lenacapavir and OBR
Oral Lead-in Period: At Day 1, participants will receive oral lenacapavir 600 mg and initiate an OBR (as prescribed by the Investigator). Participants will receive oral lenacapavir 600 mg and 300 mg at Day 2 and Day 8, respectively, while continuing their OBR.
Maintenance Period: At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive SC lenacapavir 927 mg once every 6 months (26 weeks).
Participants willing to continue beyond the study beyond Week 52 visit will receive SC lenacapavir every 6 months (26 weeks) starting at Week 52 visit, while continuing their OBR.
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: Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
Mode of DeliverySubcutaneous, Tablet
ARMsExperimental
Official Code:
NCT04150068
Trial Sponsors:
Gilead
Start Date
End Date
November 21, 2019
October 1, 2023
Enrollment:72
Age range:
12 Years ↔
any
Population:Cisgender Men, Cisgender Women, People Living with HIV