Efficacy, Safety and Optimal Dose of VM-1500 in Comparison to Efavirenz Added to Standard-of-care Antiretroviral Therapy
Status:
Completed
Trial end date:
2017-09-18
Target enrollment:
Participant gender:
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.