A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of oral VH4524184 Coadministered with Emtricitabine and Tenofovir Alafenamide in Treatment Naïve Viremic Persons with HIV-1.( INNOVATE Study)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521918-26-00

Acronym

222638

Enrollment

114

Registered

2026-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-23

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

Conditions

HIV Infections

Brief summary

Plasma HIV-1 RNA <50 copies/mL (FDA snapshot) at Month 12

Detailed description

• Plasma HIV-1 RNA <50 copies/mL (observed) until Month 24. • Plasma HIV-1 RNA <50 copies/mL (FDA snapshot) until Month 24., Change from baseline in CD4+ T-cell count until Month 24., To assess the safety and tolerability of oral VH4524184 containing regimens compared to the DTG/3TC FDC oral control arm, To assess the PK of VH4524184 during the Treatment Period

Interventions

DRUGDovato 50 mg/300 mg film-coated tablets

DRUGDescovy 200 mg/25 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Plasma HIV-1 RNA <50 copies/mL (FDA snapshot) at Month 12	—

Secondary

Measure	Time frame
• Plasma HIV-1 RNA <50 copies/mL (observed) until Month 24. • Plasma HIV-1 RNA <50 copies/mL (FDA snapshot) until Month 24., Change from baseline in CD4+ T-cell count until Month 24., To assess the safety and tolerability of oral VH4524184 containing regimens compared to the DTG/3TC FDC oral control arm, To assess the PK of VH4524184 during the Treatment Period	—

Countries

Spain

Outcome results

None listed

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