A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living with HIV-1

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505780-37-00

Acronym

212580

Enrollment

Registered

2023-12-12

Start date

2023-12-21

Completion date

2025-03-17

Last updated

2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

Maximum change from baseline (Day 1) in plasma HIV-1 RNA through Day 8

Detailed description

Incidence of SAEs, Deaths and AEs leading to Discontinuation through Day 8, VH3739937 PK parameters : Following QD dosing: • Day 1: Cmax, tmax, C24 and AUC(0 24) • Day 7: Cmax,ss, tmax, C24,ss and AUC(0-24),ss Following single dose: Cmax, tmax, AUC(0-168) and C168

Interventions

DRUGPlacebo for GSK3739937 Tablets are tablets for oral administration and visually match the active GSK3739937 Tablets with the omission of the active ingredient. Placebo for GSK3739937 Tablets are white

DRUGround

DRUGfilm coated tablets containing no markings.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Maximum change from baseline (Day 1) in plasma HIV-1 RNA through Day 8	—

Secondary

Measure	Time frame
Incidence of SAEs, Deaths and AEs leading to Discontinuation through Day 8, VH3739937 PK parameters : Following QD dosing: • Day 1: Cmax, tmax, C24 and AUC(0 24) • Day 7: Cmax,ss, tmax, C24,ss and AUC(0-24),ss Following single dose: Cmax, tmax, AUC(0-168) and C168	—

Countries

Greece, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026