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®.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
VM-1500A (parent drug of elsulfavirine) IM injection dosage form
Elsulfavirine capsules
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
Concentration of VM1500A in plasma and RBCs
Assess the clinical and virological efficacy of three dosage regimens of VM-1500A-LAI in HIV-infected patients transferred to VM-1500A-LAI from previous stable therapy (NNRTI + 2NRTI), including ELPIDA®, 20 mg capsules, lasting at least 6 months
Time frame: 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.