['hiv-1-infection']
['vm-1500', 'efavirenz', 'antiretroviral therapy (art)']

        Inclusion Criteria:

          1. Signed Patient Information and Informed Consent Form.

          2. Males and females, age ≥ 18 years.

          3. HIV-1 infection, confirmed serologically in IFA or immunoblot analysis (or documented
             HIV-1 infection).

          4. Clinically stable HIV infection (clinical stages 1 or 2 according to the WHO
             classification).

          5. Indications (in the Investigator's opinion) for ART, according to the WHO Summary
             Guideline for use of antiretroviral drugs in HIV prevention and treatment (2013).

          6. HIV-1 RNA plasma level ≥ 5 000 copies/ml at screening.

          7. СD4+ Т-cells number > 200 cells/mm3 at screening.

          8. Laboratory parameters as follows:

        White blood cells ≥ 2900/mm3 (2,9 x 109 cells/l) Absolute neutrophils ≥ 1500/mm3 (1,5 x 109
        cells/l) Platelets ≥ 100000/mm3 (100 x 109 cells/l) Hemoglobin ≥ 9.0 g/dl Total bilirubin ≤
        1.5 x ULN AST and ALT≤ 2.5 x ULN Renal function GFR > 60 ml/min

        Exclusion Criteria:

          1. Primary HIV-1 resistance to ART. Viral resistance mutations are defined as any basic
             mutations of resistance to NNRTIs, according to the updated list of VIH-1 resistance
             mutations (International AIDS society, 2013), associated with drug resistance in any
             genotype.

          2. History of antiretroviral therapy (ART), including for the prevention of vertical
             transmission of HIV.

          3. Acute hepatitis or hepatic cirrhosis of any etiology; anti-HCV antibodies or HBsAg at
             screening.

          4. Signs of acute infection or positive test result for syphilis, hepatitis A, Toxoplasma
             gondii, cytomegalovirus, gonorrhea, Chlamydia trachomatis during 30 days before
             screening.

          5. Opportunistic infections of the Category C (Centers of Disease Control (CDC), 2008),
             excluding Kaposi's sarcoma not requiring systemic therapy.

          6. History of tuberculosis of any localization, or tuberculosis at screening, according
             to x-ray examination.

          7. History of malignant tumors (except basal cell carcinoma, squamous cell carcinoma, or
             cervical carcinoma in situ, eliminated and cured ≥ 5 years ago).
      