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Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
Viriom


Information provided by (Responsible Party)
Viriom
ClinicalTrials.gov Identifier
NCT02489461

First received: June 18, 2015
Last updated: May 12, 2017
Last Verified: May 2017
History of Changes
Purpose

Purpose

To evaluate the following safety and efficacy parameters for VM-1500:

  • Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 12 (Stage I)
  • Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 24 (Stage II)
  • Decrease in viral load during 48 weeks of treatment
  • Percentage of subjects with at least 10-fold (1 log10) decrease in viral load at Week 4
  • Percentage of subjects with decrease in viral load to <400 copies/ml at Week 12
  • Percentage of subjects who continued to receive the investigational treatment up to Week 48
  • СD4+ and СD8+ cell count change during 48 weeks of the study
  • Percentage of subject who developed HIV-1 resistance to the investigational treatment by week 48
  • Frequency of adverse events (AE) of different severity according to subjective complaints, physical assessment, vital signs, laboratory tests, ECG
  • Frequency of adverse events of special interest, including of central nervous system (CNS) effects
00 pharmacokinetic profile in selected subjects

Condition Intervention Phase
HIV-infection

Drug : VM-1500
Drug : Efavirenz
Drug : Antiretroviral therapy (ART)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: International, Multicenter, Randomized, Partially Blind Clinical 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

Further study details as provided by Viriom:

Primary Outcome Measures

  • 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 ]

Estimated Enrollment: 150
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: VM-1500 20 mg (Stage I)
VM-1500 20 mg
Drug: VM-1500

VM-1500 up to 48 weeks

Drug: Antiretroviral therapy (ART)

ART up to 48 weeks

Experimental: VM-1500 40 mg (Stage I)
VM-1500 40 mg
Drug: VM-1500

VM-1500 up to 48 weeks

Drug: Antiretroviral therapy (ART)

ART up to 48 weeks

Active Comparator: Efavirenz 600 mg (Stage I and Stage II)
Efavirenz 600 mg
Drug: Efavirenz

Efavirenz up to 48 weeks

Other Name: Stocrin®
Drug: Antiretroviral therapy (ART)

ART up to 48 weeks

Experimental: VM-1500 (optima dose) (Stage II)
VM-1500 (optimal dose)
Drug: VM-1500

VM-1500 up to 48 weeks

Drug: Antiretroviral therapy (ART)

ART up to 48 weeks

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02489461

Locations

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
More Information

More Information


Responsible Party: Viriom  
ClinicalTrials.gov Identifier: NCT02489461   History of Changes  
Other Study ID Numbers: HIV-VM1500-04  
Study First Received: June 18, 2015  
Last Updated: May 12, 2017  

Additional relevant MeSH terms:
HIV Infections
Efavirenz

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.