Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance (CAPELLA)
Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance (CAPELLA)
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).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Participants will be enrolled into Cohort 2 if Cohort 1 is fully enrolled or if they do not meet the criteria for randomization in Cohort 1.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Knowledge of treatment assignments will be masked during the Functional Monotherapy Period in Cohort 1.
Primary Purpose: Treatment
Official Title: A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance
Actual Study Start Date: November 21, 2019
Estimated Primary Completion Date: October 2020
Estimated Study Completion Date: October 2023
Arm:
- Experimental: Cohort 1A Lenacapavir, Failing ARV Regimen, and OBR
- Placebo Comparator: Cohort 1B: Placebo, Lenacapavir, Failing ARV Regimen, and OBR
- Experimental: Cohort 2: Lenacapavir and OBR
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 100 |
| Study start date | 21 November 2019 |
| Estimated study completion date | 01 October 2023 |