HIV Infections Clinical Research Study

What is the purpose of this study?

The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800 mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PEG2b) 1.5 ug/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (R) (600 mg/day to 1400 mg/day) PO to therapy with PEG2b + R alone in adult subjects coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis C virus (HCV) genotype 1. Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit viral replication in HCV-infected host cells. The mechanism of inhibition represents a new mechanism of action compared to both interferon alfa and ribavirin. Based on previous experience with PEG2b and ribavirin in combination (PEG2b/R) with boceprevir in the HCV-monoinfected population, this combination treatment is expected to provide significant benefit to the HIV/HCV coinfected population. Given the high unmet medical need of these patients and the benefit of the addition of boceprevir to PEG2b/R, it is important to demonstrate the safety and efficacy of boceprevir in combination with PEG2b/R in subjects coinfected with HIV/HCV. This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in combination with open-label PEG2b/R in subjects coinfected with HIV and previously untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical Practice (GCP). This trial consists of two arms, one control arm (Arm1) and one experimental arm (Arm 2). Subjects in the control arm (Arm1) may receive boceprevir/PEG2b/R via a crossover arm.

Can I participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions: HIV Infections, Hepatitis C, HCV Infection
• Age: Between 18 - 65 Years
• Gender: Male or Female
• +

  Inclusion Criteria:

  >=18 and <=65 years of age

  Body weight >=40 and <=125 kg

  History of HIV infection for greater than 6 months prior to Day 1

  On an optimized anti-retroviral treatment regimen (OTR) with stable HIV disease with

  CD4 >=200 cells/uL and HIV-1 RNA viral load <50 copies/mL

  Documented chronic hepatitis C (CHC) genotype 1 infection (greater than 6 months

  prior to Day 1)

  Liver biopsy with histology consistent with CHC and no other etiology

  Use of acceptable methods of contraception 2 weeks prior to Day 1 and at least 6

  months or longer after treatment
• +

  Exclusion Criteria:

  Subjects who received prior treatment for hepatitis C other than herbal remedies

  Coinfected with hepatitis B virus (Hepatitis B surface antigen (HBsAg) positive)

  and/or demonstrating signs and symptoms consistent with concomitant infection

  Evidence of decompensated liver disease

  Subjects who have changed their anti-retroviral regimen within the last 3 months

  prior to Day 1 or had first initiated anti-retroviral therapy within the last 6

  months prior to Day 1

  Use of certain HIV medications will not be allowed. Medications will be reviewed by

  the Investigator

  History of clinically significant opportunistic infections (except oral thrush)

  within the last year prior to Day 1

  Current evidence of substance abuse

  History of a clinical diagnosis, within the past 6 months of substance abuse

  Subjects receiving opiate agonist substitution therapy but not enrolled in an opiate

  ubstitution maintenance program

  History of marijuana use deemed excessive by the Investigator

  Infected with HIV-2

  Use of any HIV protease inhibitor without the coadministration of ritonavir within

  one month of Day 1 and throughout the period of the trial

  Key Laboratory Exclusion Criteria:

  Hematologic, biochemical, and serologic criteria (growth factors may not be used to

  achieve trial entry requirements):

  Hemoglobin <11 g/dL for females and <12 g/dL for males

  Neutrophils <1500/mm^3 (blacks/African-Americans: <1200/mm^3)

  Platelets <100,000/mm^3

  Direct bilirubin >1.5 x ULN (upper limit of normal) of the laboratory reference

  range. Total bilirubin >1.6 mg/dL unless history of Gilbert's disease or

  antiretroviral regimen contains atazanavir. If Gilbert's disease is the proposed

  etiology, this must be documented in the subject's chart

  Alpha fetoprotein (AFP):

  AFP >100 ng/mL OR

  AFP 50 to 100 ng/mL (requires a liver ultrasound and subjects with findings

  uspicious for hepatocellular carcinoma are excluded)

Detail Study Description

Study Treatments

PEG2b plus ribavirin followed by placebo, PEG2b plus ribavirin followed by boceprevir/PEG2b/ribavirin

Last Updated: April 2010

Currently Recruiting