hiv patients with chronic hepatitis c genotype 1 infection who failed previously to peginterferon /ribavirin

Conditions: Hepatitis C; HIV Infections; COINFECTION

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 criteria:
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.

Keywords: hcv hiv coinfection