HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin

A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin Eudra CT2012-003984-23

The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy.

In a total number of 108 patients the protocol was evaluated but only in 102 the protocol efectively was presented. In the remaining 6 patients we don't believe the trial could be performed.

Inclusion Criteria:

• For inclusion in the study, subjects must have a qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen.

• Subject must have previously documented chronic hepatitis C (CHC) genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the screening visit must confirm genotype 1 infection and be ≥10,000 IU/mL.

• Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:

  1. No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
  2. Cirrhosis. No specific length of time would be requested.

• All patients with cirrhosis must have an ultrasound 6 month within of screening visit.

• Patients must be on stable antiretroviral therapy including a CD4 cell count of more than 100 per mm3 and a HIV plasmatic viral load undetectable (it is < 50 copies/mL) for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least during the last 3 months).

• Subject must be ≥18 years of age.

• HIV treatment should not contain efavirenz (EFV), nevirapine (NVP), etravirine (ETV), didanosine (ddI), stavudine (d4T), zidovudine (AZT), or HIV protease inhibitors.

• Subject must weight between 40 kg and 125 kg.

• Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug.

• Subjects must be willing to give written informed consent and by investigator opinion be able to follow the protocol visit design.

Exclusion Criteria:

• Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
• Patients chronically infected with HCV genotype other than 1
• CD4 cell count < 100 cel/mm3.
• Plasma HIV RNA more than 50 copies/mL
• Platelet count less than 80.000 /mm3
• Subjects who required discontinuation of previous interferon or ribavirin regimen for a severe adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
• Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
• Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
• Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
• History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
• Evidence of decompensate liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
• Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
• Unstable or untreated pre-existing psychiatric condition.
• Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
• Any current evidence of substance abuse of alcohol or other drugs.
• Subjects receiving opioid agonist substitution therapy but not enrolled in an opiate substitution maintenance program.