NCT05163535

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®

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Viriom · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

Detailed description

The clinical study will consist of the following stages: 1. Screening: On Week 2, after signing the Patient Information Sheet and the Informed Consent form, subjects will undergo screening procedures to assess the inclusion/exclusion criteria. Patients meeting all inclusion / exclusion criteria will be invited to the center for randomization and initiation of study drug therapy. 2. Study treatment period: Once the inclusion / exclusion criteria have been confirmed, patients will be randomized to one of four treatment groups. For patients assigned to Groups 1, 2 and 3, all i/m injections of VM-1500A-LAI will be administered at Week 0, Week 4 and Week 8 by the study physician at the center, where they will remain monitored for up to 2 hours. Patients will also receive 2NRTI according to the standard regimen. Blood samples for PK study will be taken immediately before and 2 hours after each i/m injection of VM-1500A-LAI. Patients assigned to Group 4 will receive daily ELPIDA® 20 mg in the morning and 2NRTIs according to the standard regimen. 3. End of Therapy: At the end of the study therapy course, patients will be invited to the study center for a Week 12 visit for the end of therapy visit procedures. 4. Follow-up Observation period: After the end of the course of study therapy, patients will be monitored for another 4 weeks. Patients will be invited to the center for a Follow-up Visit at Week 16. Follow-Up to obtain the data on adverse events will be continued for up to 30 days after the last visit or the last study procedure planned in the Study Protocol.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	VM-1500A-LAI	VM-1500A (parent drug of elsulfavirine) IM injection dosage form
OTHER	ELPIDA®	Elsulfavirine capsules

Timeline

• Start date: 2021-01-19
• Primary completion: 2021-08-03
• Completion: 2021-08-03
• First posted: 2021-12-20
• Last updated: 2022-01-11

Locations

2 sites across 1 country: Russia