Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects
Condition: HIV Infection; Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Intervention: Nitazoxanide (NTZ); Pegylated interferon alfa-2a (PEG); Ribavirin (RBV)
Intervention description: 500 mg twice daily, taken orally with food; 180 micrograms via subcutaneous injection once weekly; Weight-based dosing; 1,000 mg daily, taken orally, for people weighing less than 75 kg or 1,200 mg for people weighing at least 75 kg.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Nitazoxanide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C genotype 1; HCV treatment naive; HCV/HIV coinfection; Antiretroviral; Ribavirin; Pegylated Interferon alfa; Nitazoxanide

Summary:

      Infection with hepatitis C virus (HCV) can cause liver scarring, or cirrhosis, and this
      usually occurs more rapidly among people infected with both HCV and human immunodeficiency
      virus (HIV). People infected with both HCV and HIV have poor response to the current HCV
      treatments. This phase II pilot study evaluated whether adding a new HCV medication improves
      response to the current standard HCV treatment with pegylated interferon and ribavirin in
      people with both HCV and HIV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection

          -  Documentation of hepatitis C virus (HCV) genotype 1 infection prior to entry

          -  Chronic HCV infection for at least 180 days

          -  CD4+ cell count greater than 200 cells/mm3 obtained within 90 days prior to study
             entry

          -  Detectable HCV viral load obtained within 90 days prior to study entry

          -  Any change in antiretroviral (ARV) regimen, including initiation of antiretroviral
             therapy (ART), a switch in ART regimen, or a discontinuation of ART, had to have
             occurred more than 60 days prior to study entry. Breaks in therapy for a maximum of 14
             days total during the 60-day period were allowed. Participants not on ART should have
             had no plans to initiate therapy during the first 24 weeks after study entry.
             Participants who did start ART did not have to discontinue study treatment.
             Participants on ART should have planned to remain on the same therapy for at least 12
             weeks after study entry. Changes in formulation or dosage were permitted.

          -  Certain laboratory values obtained within 42 days prior to study entry

          -  Agreement to use contraception, if participating in sexual activity that could lead to
             pregnancy, for the duration of study and for 6 months afterward

          -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
             phosphatase less than or equal to five times the upper limit of normal (ULN)

          -  Hemoglobin >=11 g/dl for men and >=10 g/dl for women

        Exclusion Criteria:

          -  Use of the ARV didanosine (ddI)

          -  Receipt of any interferon

          -  Receipt of any therapy for HCV, including ribavirin (RBV) or experimental treatment

          -  Decompensated cirrhosis

          -  Currently active or other known causes of significant liver disease, including chronic
             or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygous alpha-1
             antitrypsin deficiency

          -  Pregnancy or breastfeeding

          -  Men with pregnant sexual partners or men planning pregnancy with any sexual partner
             during treatment or for 24 weeks after treatment completion

          -  Uncontrolled or active depression, other psychiatric disorder, or any hospitalization
             within the past 52 weeks that, in the opinion of the site investigator, would prevent
             participation

          -  Prior suicide attempt

          -  Active thyroid disease (use of thyroid hormone replacement therapy permitted if
             thyroid stimulating hormone [TSH] or free thyroxine [T4] in the normal range)

          -  History of autoimmune processes, including Crohn's disease, ulcerative colitis, severe
             psoriasis, or rheumatoid arthritis, that may be exacerbated by interferon use

          -  Systemic antineoplastic or immunomodulatory treatment or radiation within 24 weeks
             prior to study entry

          -  Serious illness, including malignancy or active coronary artery disease, within 24
             weeks prior to study entry

          -  Chronic medical condition that, in the site investigator's opinion, might preclude
             completion of the protocol

          -  Presence of acute or active opportunistic infections within 24 weeks prior to study
             entry

          -  Evidence of hepatocellular carcinoma (HCC) or alpha-fetoprotein level of greater than
             50 ng/ml unless an imaging procedure (e.g., computed tomography [CT] scan or magnetic
             resonance imaging [MRI]) showed no evidence of a hepatic tumor. Each may have been
             obtained up to 24 weeks before study entry.

          -  History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency
             toward hemolysis

          -  History of major organ transplantation with an existing functional graft

          -  Known allergy, sensitivity, or any hypersensitivity to components of study drugs or
             their formulations

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements