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Open Labelled, Randomized Study to Evaluate the Efficacy, Safety and Dose Selection of VM-1500A-LAI Drug in HIV-infected Patients Transferred From Previous Stable Therapy (NNRTI + 2NRTI), Including ELPIDA®

NCT05163535 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-01-11

No results posted yet for this study

Summary

Open labelled, randomized study to evaluate the efficacy, safety and dose selection of VM-1500A-LAI drug in HIV-infected patients transferred from previous stable therapy (NNRTI + 2NRTI), including ELPIDA®.

Conditions

Interventions

DRUG

VM-1500A-LAI

VM-1500A (parent drug of elsulfavirine) IM injection dosage form

OTHER

ELPIDA®

Elsulfavirine capsules

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
2021-01-19
Primary Completion
2021-08-03
Completion
2021-08-03

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 NCT05163535 on ClinicalTrials.gov