NCT05996471

A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV. VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	VH3810109	VH3810109 will be administered.
DRUG	Cabotegravir	Cabotegravir will be administered.
DRUG	Standard of care (SOC)	Pre-baseline SOC antiretroviral therapy (ART) will be administered.
BIOLOGICAL	rHuPH20	rHuPH20 will be administered.

Timeline

• Start date: 2023-08-17
• Primary completion: 2026-05-22
• Completion: 2028-11-09
• First posted: 2023-08-18
• Last updated: 2026-03-11

Locations

45 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study