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

NCT05204394 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2022-01-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

VM-1500A-LAI

Injectable nanoformulation of depulfavirine (parent drug of elsulfavirine)

OTHER

Standard of Care

Any oral 1st line approved HIV treatment regimen

Sponsors & Collaborators

  • Viriom

    lead INDUSTRY

Principal Investigators

  • Anastasia Pokrovskaya, PhD · Central Research Institute of Epidemiology of Rospotrebnadzor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-09-30
Completion
2023-10-16

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05204394 on ClinicalTrials.gov