Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection
Objectives: 1. Primary objective: To Evaluate the rate of sustained virological response (SVR) of pegylated interferon alfa-2b (Peg-IFN) plus ribavirin (RBV) plus nitazoxanide (NTZ) in patients coinfected by HIV and HCV genotype 4 (HCV-4), never treated before (naïve) and with a treatment failure to a standard therapy with Peg-IFN plus RBV (experienced), and to compare it with the rate of SVR of these patients with Peg-IFN plus RBV is a historical cohort. 2. Secondary objectives: In naive, as well as in experienced patients: a) To evaluate the virological activity at weeks 4 and 12 after starting the combination of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients. b) To analyze the safety of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients.
Design: Pilot clinical trial without control to evaluate efficacy and safety (phase II).
Patients: Individuals with HIV infection and with confirmed chronic HCV infection.
Treatment: NTZ 500 mg every 12 hours during 4 weeks, followed by NTZ 500 mg every 12 hours plus Peg-IFN plus weigh-adjusted RBV for 48 weeks. Total duration of therapy: 52 weeks.
Primary variable: The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing the programmed length of treatment.
Secondary variables: 1. The frequency of individuals with HCV RNA ≤10 IU/ml 12 weeks after finishing the programmed length of treatment. 2. The proportion of patients with HCV RNA ≤10 IU/ml at 4 and 12 weeks after adding PegIFN plus RBV to NTZ. 3. The frequency of severe adverse events.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Trial to Evaluate the Antiviral Activity of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in Individuals With Chronic Hepatitis Due to HCV Genotype 4 and Coinfected by HIV|
- Sustained virological response [ Time Frame: 24 weeks after finishing the scheduled treatment ] [ Designated as safety issue: No ]The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing the programmed length of treatment (52 weeks).
- Safety of Peg-interferon plus ribavirin plus nitazoxanide [ Time Frame: Every 4 weeks until 28 weeks of treatment, then every 8 weeks until the end of treatment (52 weeks) ] [ Designated as safety issue: Yes ]The proportion of patients with grade 3 or 4 adverse events according to the WHO classification.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Nitazoxanide 500 mg bid po for 4 weeks, followed by nitazoxanide 500 mg bid plus pegylated interferon alpha 2b 1.5 mg/kg/week sc plus weight-adjusted ribavirin po for 48 weeks.
Main Objective To evaluate the SVR rate of treatment with Peg-IFN alfa-2b plus RBV and NTZ in patients coinfected with HIV and HCV genotype 4, both never exposed to therapy against HCV or who failed a previous treatment with Peg-IFN plus RBV, and to compare with the SVR rate obtained in patients with Peg-IFN plus RBV in a historical cohort.
Secondary objectives: In naive, as well as in experienced patients:
- To evaluate the virological activity at weeks 4 and 12 after starting the combination of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients.
- To analyze the safety of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients.
Design Single arm pilot clinical trial to evaluate safety and efficacy (phase II).
Disease or disorder under study Coinfection with HIV and HCV genotype 4.
Drugs under study Nitazoxanide 500 mg every 12 hours for 4 weeks followed by nitazoxanide 500 mg every 12 hours plus pegylated interferon alfa-2b 1.5 mcg/kg/week and weight-adjusted ribavirin for 48 weeks.
Study Population and total number of subjects Patients infected with HIV-1 with chronic HCV genotype 4 who meet the selection criteria.
Number of patients included in the study: 45.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529073
|Seville, Spain, 41014|
|Principal Investigator:||Juan Macías, MD, PhD||Infectious Diseases and Microbiology Unit. Hospital Universitario de Valme. Servicio Andaluz de Salud|