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

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ClinicalTrials.gov Identifier: NCT02489461
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Viriom

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: VM-1500 Drug: Efavirenz Drug: Antiretroviral therapy (ART) Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 2014
Actual Primary Completion Date : April 5, 2016
Actual Study Completion Date : September 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV
Drug Information available for: Efavirenz

Arms and Interventions
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Arm Intervention/treatment
Experimental: VM-1500 20 mg + ART
VM-1500 - 20 mg (Stage I), then optimal dose (Stage II and Open-Label Stage), ART
 Drug: VM-1500
VM-1500 up to 96 weeks
Other Names:
  • Elsulfavirine
  • Elpida®

Drug: Antiretroviral therapy (ART)
Antiretroviral therapy up to 96 weeks
Other Name: standard antiretroviral therapy of two NNRTIs
Experimental: VM-1500 40 mg + ART
VM-1500 - 40 mg (Stage I), then optimal dose (Stage II and Open-Label Stage), ART
 Drug: VM-1500
VM-1500 up to 96 weeks
Other Names:
  • Elsulfavirine
  • Elpida®

Drug: Antiretroviral therapy (ART)
Antiretroviral therapy up to 96 weeks
Other Name: standard antiretroviral therapy of two NNRTIs
Active Comparator: Efavirenz 600 mg + ART
Efavirenz 600 mg (Stage I and Stage II), ART
 Drug: Efavirenz
Efavirenz up to 48 weeks
Other Name: Stocrin®

Drug: Antiretroviral therapy (ART)
Antiretroviral therapy up to 96 weeks
Other Name: standard antiretroviral therapy of two NNRTIs


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of HIV-1 RNA level in blood plasma <400 copies/ml [ Time Frame: 12 weeks ]
    Comparison of the percentage of patients with reduced viral load to < 400 copies/ml at Week 12 in VM-1500 20 mg, VM-1500 40 mg and Efavirenz treatment groups


Secondary Outcome Measures :
  1. Reduction of HIV-1 RNA level in blood plasma <50 copies/ml [ Time Frame: 24 weeks ]
    Comparison of the percentage of patients with reduced viral load to an undetectable level (< 50 copies/ml) at Week 24 in VM-1500 group with the selected dose and Efavirenz group.

  2. Reduction of HIV-1 RNA level in blood plasma <50 copies/ml [ Time Frame: 48 weeks ]
    Comparison of the percentage of patients with reduced viral load to an undetectable level (< 50 copies/ml) at Week 48 in VM-1500 group with the selected dose and Efavirenz group.

  3. Change in the absolute CD4+ lymphocytes count [ Time Frame: 48 weeks ]
    Change in the absolute CD4+ lymphocytes count from Baseline to Week 48 in VM-1500 group with the selected dose and Efavirenz group.

  4. Change in the absolute CD8+ lymphocytes count [ Time Frame: 48 weeks ]
    Change in the absolute CD8+ lymphocytes count from Baseline to Week 48 in VM-1500 group with the selected dose and Efavirenz group.

  5. The percent of patients with study therapy-resistant HIV-1 development [ Time Frame: 48 weeks ]
    The proportion of patients who develop study therapy-resistant HIV-1 from Baseline to Week 48 in VM-1500 group with the selected dose and Efavirenz group.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489461


Locations
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Russian Federation
Kaluga regional center for AIDS prevention
Kaluga, Kaluga Region, Russian Federation
Lipetsk regional center for AIDS prevention
Lipetsk, Lipetsk Region, Russian Federation, 398043
Perm Regional center for AIDS prevention
Perm, Perm Region, Russian Federation, 614088
Ryazan Regional Clinical Dermatovenerologic Dispensary
Ryazan, Ryazan Region, Russian Federation, 390046
City center for AIDS prevention
Tolyatti, Samara Region, Russian Federation, 445846
Republican hospital for AIDS prevention
Kazan, Tatarstan Republic, Russian Federation, 420097
Udmurtia Republican hospital for AIDS prevention
Izhevsk, Udmurtia Republic, Russian Federation, 426067
Volgograd regional center for AIDS prevention
Volgograd, Volgograd Region, Russian Federation, 400040
Central Scientific Research Institute of Epidemiology
Moscow, Russian Federation, 105275
Moscow Infectional Clinical Hospital #2
Moscow, Russian Federation, 105275
Moscow Prevention AIDS Center
Moscow, Russian Federation, 129110
St.Petersburg city center for AIDS prevention
St.Petersburg, Russian Federation, 190103
Clinical infectious diseases hospital n.a. S.P. Botkin"
St.Petersburg, Russian Federation, 191167
Sponsors and Collaborators
Viriom
Investigators
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Study Chair: Irina Y Tyrnova Viriom,LLC
More Information
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Responsible Party: Viriom
ClinicalTrials.gov Identifier: NCT02489461    
Other Study ID Numbers: HIV-VM1500-04
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viriom:
HIV
Additional relevant MeSH terms:
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Efavirenz
Elsulfavirine
Anti-Retroviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
 Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Anti-HIV Agents