Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE)
Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE)
The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with HIV (PLWH).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIV
Actual Study Start Date: November 22, 2019
Estimated Primary Completion Date: October 2021
Estimated Study Completion Date: May 2023
Arm:
- Experimental: Lenacapavir, F/TAF, and TAF
- Experimental: Lenacapavir, F/TAF, and BIC
- Experimental: Lenacapavir and F/TAF
- Active Comparator: B/F/TAF
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 175 |
| Study start date | 22 November 2019 |
| Estimated study completion date | 01 May 2023 |