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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE July 3, 2015
Last Update Posted Date September 25, 2018
Actual Study Start Date  ICMJE August 5, 2014
Actual Primary Completion Date April 5, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • Optimal dose selection for VM-1500 in combination with two nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) based on analysis of AEs, laboratory values, subjects' diaries. [ Time Frame: 48 weeks ]
  • Efficacy evaluation of VM-1500 (optimal dose selected at Stage I) in combination with two NRTIs, as compared to Efavirenz in combination with two NRTIs based on analysis of viral load. [ Time Frame: 52 weeks ]
  • Safety evaluation of VM-1500 (optimal dose selected at Stage I) in combination with two NRTIs, as compared to Efavirenz in combination with two NRTIs based on analysis of AEs, laboratory values and subjects' diaries. [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Optimal Dose of VM-1500 in Comparison to Efavirenz Added to Standard-of-care Antiretroviral Therapy
Official Title  ICMJE 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
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV-1-infection
Intervention  ICMJE
  • Drug: VM-1500
    VM-1500 up to 96 weeks
    Other Names:
    • Elsulfavirine
    • Elpida®
  • 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
Study Arms  ICMJE
  • Experimental: VM-1500 20 mg + ART
    VM-1500 - 20 mg (Stage I), then optimal dose (Stage II and Open-Label Stage), ART
    Interventions:
    • Drug: VM-1500
    • Drug: Antiretroviral therapy (ART)
  • Experimental: VM-1500 40 mg + ART
    VM-1500 - 40 mg (Stage I), then optimal dose (Stage II and Open-Label Stage), ART
    Interventions:
    • Drug: VM-1500
    • Drug: Antiretroviral therapy (ART)
  • Active Comparator: Efavirenz 600 mg + ART
    Efavirenz 600 mg (Stage I and Stage II), ART
    Interventions:
    • Drug: Efavirenz
    • Drug: Antiretroviral therapy (ART)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2015)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 18, 2017
Actual Primary Completion Date April 5, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02489461
Other Study ID Numbers  ICMJE HIV-VM1500-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Viriom
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Viriom
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Irina Y Tyrnova Viriom,LLC
PRS Account Viriom
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP