Clinical trial NCT01718301: HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
HIV Infections
COINFECTION
Keywords: HCV
HIV
Coinfection
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Achievement of sustained virological response (SVR) at week 24
timeFrame: Week 24
Secondary outcomes:
measure: Achievement of sustained virological response at weeks 2,4,8,12.
timeFrame: Weeks 2, 4, 8, 12
measure: The proportion of subjects with undetectable HCV-RNA at FW 12.
timeFrame: Week 12
measure: The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.
timeFrame: Week 72
measure: Number of adverse events
timeFrame: From baseline to study completion (up to 72 weeks)
measure: Resistance of HCV after boceprevir (BOC) containing regimen
timeFrame: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
Study officials:
affiliation: Hospital Clínic i Provincial de Barcelona
name: Josep Mallolas, MD
role: PRINCIPAL_INVESTIGATOR
References: