NCT02489461

Efficacy, Safety and Optimal Dose of VM-1500 in Comparison to Efavirenz Added to Standard-of-care Antiretroviral Therapy

International, Multicenter, Randomized, Partially Blind Study to Evaluate Efficacy, Safety and Selection of the Optimal Dose for VM-1500 in Comparison to Efavirenz in Combination With Two NRTIs in Treatment-naïve, HIV-1 Infected Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Viriom · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is conducted in two stages and open-label stage of the study. At the first stage of the study, the main purpose was to choose the optimal dose of VM-1500 (20 mg or 40 mg per day) in addition to standard-of-care basic antiretroviral therapy consisting of two NRTIs, in terms of reduction of viral load at Week 12 (\<400 copies/ml) in treatment-naïve HIV-1-infected patients. At the second stage of the study, the main purpose was to evaluate efficacy of VM- 1500 (in the optimal dose selected at the first stage of the study) in comparison to Efavirenz added to standard-of-care antiretroviral therapy of two NRTIs, in terms of reduction of viral load at Week 24 to the undetectable level (\<50 copies/ml) in treatment-naïve HIV-1 infected patients. Open-label stage of the study continued evaluation of viral load and immunological and safety parameters in HIV-1 patients receiving VM-1500 up to Week 96 and additional PK up to Week 100.

Detailed description

This project is an international, multicenter, randomized, partially blind clinical study to evaluate efficacy and safety of two different doses of VM-1500 in comparison with Efavirenz added to standard antiretroviral therapy including two NRTIs in treatment-naïve HIV-1-infected patients.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	VM-1500	VM-1500 up to 96 weeks
DRUG	Efavirenz	Efavirenz up to 48 weeks
DRUG	Antiretroviral therapy (ART)	Antiretroviral therapy up to 96 weeks

Timeline

• Start date: 2014-08-05
• Primary completion: 2016-04-05
• Completion: 2017-09-18
• First posted: 2015-07-03
• Last updated: 2018-09-25

Locations

13 sites across 1 country: Russia