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

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)

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.

Inclusion Criteria:

• Participant must be at least 18 years of age (or older, if required for adults by local regulations).

• Screening CD4+ T-cell count ≥ 200 cells/µL.

• Documented HIV-1 infection and screening plasma HIV-1 RNA ≥

  1 000 and ≤ 100 000 copies/mL.

• Treatment-naïve. Prior use of oral pre-exposure prophylaxis (PrEP) or oral post-exposure prophylaxis (PEP) that is not INSTI or CAI based is permitted.

• Body weight ≥ 50.0 kg (110 lbs) for participants assigned male at birth and ≥ 45.0 kg (99 lbs) for participants assigned female at birth.

• Agrees to adequate birth control if a participant of childbearing potential

Exclusion Criteria:

• Participants with acute HIV-1 infection
• Prior exposure to any HIV-1 capsid inhibitor or any HIV-1 INSTI for any reason is prohibited.
• Participants with known or suspected presence of major virologic resistance mutations to study drugs
• Unstable liver disease
• Participants with HCV co-infection
• Participant has evidence of chronic active HBV infection
• Clinically significant cardiovascular disease