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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
438
Injectable nanoformulation of depulfavirine (parent drug of elsulfavirine)
Any oral 1st line approved HIV treatment regimen
Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor
Moscow, Russia
St. Petersburg State Medical Institution " Center for AIDS and Infectious Diseases"
Saint Petersburg, Russia
Proportion of participants with plasma HIV-1 RNA level > 50 copies/mL
Proportion of participants with plasma HIV-1 RNA level \> 50 copies/mL at Week 48 using the snapshot algorithm (FDA).
Time frame: 48 Weeks
Percentage of patients with undetectable viral load
Percentage of patients with HIV-1 RNA \< 50 copies/ml at Week 48
Time frame: 48 Weeks
Proportion of patients with Confirmed Virologic Failure
Proportion of patients with Confirmed Virologic Failure (two consecutive plasma HIV-1 RNA levels \> 200cmL after prior suppression to \< 200copies/ml) at Week 48
Time frame: 48 Weeks
Change in the absolute lymphocyte counts
Change in the absolute CD4+ and CD8+ lymphocyte counts over 48 weeks
Time frame: 48 Weeks
Percentage of patients with developed HIV-1 resistance
Percentage of patients who develop HIV-1 resistance to study therapy over 48 weeks
Time frame: 48 Weeks
Incidence of AEs / SAEs
Time frame: 48 Weeks
VM-1500A plasma concentration
To assess PK parameters of VM-1500A-LAI
Time frame: 48 Weeks
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