The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1 infected patients
The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of rapid (after the 4th week) and early (after the 12th week) virologic response will be based on polymerase chain reaction data. For patients with treatment failure after the 12th week the antiviral therapy shall be discontinued. All patients who require further anti-viral treatment will receive a combination treatment with Algeron / PegIntron and ribavirin for another 36 weeks. Sustained virologic response will be assessed 24 weeks after last dose of study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
State Public Healthcare Institution National Center for the Prevention and Control of AIDS and other infectious diseases of the Ministry of Health of the Republic of Tatarstan
Kazan', Tatarstan Republic, Russia
State Institution of Nizhny Novgorod region "Regional Center for Prevention and Control of AIDS and other infectious diseases"
Nizhny Novgorod, Russia
State Healthcare Institution Center for the Prevention and Control of AIDS and infectious diseases of the city, St.Petersburg CityHealth Department
Saint Petersburg, Russia
State Budgetary Higher Vocational Education Institution V.I. Razumovsky Saratov State University of medicine
Saratov, Russia
State Budgetary Higher Vocational Education Institution Pacific State Medical University, Ministry of Health of the Russian Federation
Vladivostok, Russia
State Healthcare Institution "Volgograd Regional Center for the Prevention and Control of AIDS and infectious diseases"
Volgograd, Russia
Early Virological Response
Proportion of randomized patients achieving early virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (\< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment
Time frame: 12 weeks
Early Virological Response in Patients With Different Hepatitis C Virus Genotypes
Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving early virologic response - negative polymerase chain reaction result for HCV ribonucleic acid (\< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment
Time frame: 12 weeks
Rapid Virological Response
Proportion of randomized patients achieving rapid virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (\< 15 IU/ml) after 4 weeks of treatment
Time frame: 4 weeks
Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes
Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving rapid virological response - negative polymerase chain reaction result for HCV ribonucleic acid (\< 15 IU/ml) after 4 weeks of treatment
Time frame: 4 weeks
Viral Breakthrough
Proportion of patients in each groups with level of Hepatitis C Virus ribonucleic acid \> 15 IU/ml after Hepatitis C Virus ribonucleic acid was not present or Hepatitis C Virus ribonucleic acid was increased by more than 1log10 from baseline at 4 or 12 weeks of treatment
Time frame: screening data and at 4 or 12 weeks of treatment.
Biochemical Response
Proportion of patients in each group with alanine aminotransferase level ≤ upper normal limit after 12 weeks of therapy
Time frame: 12 weeks
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