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NOT YET RECRUITING
NCT07816250
PHASE2

A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

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

DRUG

VH4011499

Participants receive injectable VH4011499 at different dose groups.

DRUG

CAB

Participants receive injectable CAB.

DRUG

DTG/3TC

Participants receive DTG/3TC orally once daily.