NCT05204394

Study to Evaluate Efficacy and Safety of Switching to VM-1500A-LAI + 2NRTIs From the 1st Line Standard of Care Therapy

Multicenter, Open-label, Randomized, Active Control Study to Evaluate Efficacy and Safety of Switching to VM-1500A-LAI + 2NRTIs From the 1st Line Standard of Care Therapy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 438 (estimated)
• Sponsor: Viriom · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open-label, randomized, active control study to evaluate efficacy and safety of switching to VM-1500A-LAI + 2NRTIs from the 1st line standard of care therapy for 48 weeks. The 1st part of the study will select one of 2 dose cohorts: 600mg or 900mg.

Detailed description

Eligible patients will be randomized (1:1:1) into 3 treatment groups - LAI 600 (ELPIDA+VM-1500A-LAI 600 mg), LAI 900 (ELPIDA+VM-1500A-LAI 900 mg), and Standard of Care (SoC) therapy. Patients of LAI groups will be assigned by ELPIDA®, 20 mg capsules (and same 2NRTIs) daily therapy for 4 weeks, then one IM injection of 1200 mg VM-1500A-LAI followed by 5 IM monthly injections of 600 mg or 900 mg VM-1500A-LAI QM. When all patients in the VM-1500A-LAI 600mg and VM-1500A-LAI 900 mg dose cohorts complete 24 weeks, the interim analysis will be performed in order to select the dosage regimen for VM-1500A-LAI to continue for additional 28 weeks for a total of 52 weeks of treatment. The analysis will be based on efficacy assessment (number of patients treated with VM1500-LAI who showed the viral load ≥ 50 copies/ml at Week 24 using FDA snapshot algorithm as well as on the basis of a safety and tolerability assessment (assessment of the frequency and severity of AEs associated with the study drug). The optimal dosage regimen will be selected by the IDMC. 4 weeks after the End of Treatment visit, subjects will come for the Follow-up visit.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	VM-1500A-LAI	Injectable nanoformulation of depulfavirine (parent drug of elsulfavirine)
OTHER	Standard of Care	Any oral 1st line approved HIV treatment regimen

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-09-30
• Completion: 2023-10-16
• First posted: 2022-01-24
• Last updated: 2022-01-24

Locations

2 sites across 1 country: Russia