Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection
Status:
Unknown status
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
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.