HIV Infection Clinical Trial
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
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.
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:
1. 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.
2. 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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