Patient case: 34-year-old female with melanoma; genetic feature: NRAS (Q61L)

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

Summary: 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.


Eligibility: 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.

Relevance to patient case: not relevant