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A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)
Sponsor: ViiV Healthcare
Summary
The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI). This study will explore 4 different regimens of VH4011499 when paired with cabotegravir (CAB) as an initial two-drug regimen.
Official title: A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of 2-drug Injectable Regimens of VH4011499 Plus Cabotegravir in Treatment Naïve Viremic Adult Participants With HIV-1 (CINERGY)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-10-19
Completion Date
2032-06-11
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
VH4011499
Participants receive injectable VH4011499 at different dose groups.
CAB
Participants receive injectable CAB.
DTG/3TC
Participants receive DTG/3TC orally once daily.