Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-30 @ 5:47 AM
Study NCT ID:
NCT05163535
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2021-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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®
Sponsor:
Viriom
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: