A phase III open label 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.
- Conditions
- HCV and HIV seropositive coinfectionMedDRA version: 14.1Level: LLTClassification code 10065949Term: HCV coinfectionSystem Organ Class: 100000004862MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003984-23-ES
- Lead Sponsor
- Fundació Clínic per a la Recerca Biomèdica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
The subject must meet ALL criteria listed below for entry
1. 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.
2. Subject must have previously documented 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.
3. Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:
a. No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
b. Cirrhosis. No specific length of time would be requested.
4. All patients with cirrhosis must have an ultrasound 6 month within of screening visit.
5. 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).
6. Subject must be ?18 years of age.
7. HIV treatment should not contain EFV, NVP, ETV, ddI, d4T, AZT, or HIV protease inhibitors.
8. Subject must weight between 40 kg and 125 kg.
9. 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.
10. Subjects must be willing to give written informed consent and by investigator opinion could follow the protocol visit design.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
2. Patients chronically infected with HCV genotype other than 1
3. CD4 cell count < 100 cel/mm3.
4. Plasma HIV RNA more than 50 copies/mL
5. Platelet count less than 80.000 /mm3
6. 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.
7. Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
8. Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
9. Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
10. History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
11.. Evidence of decompensate liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
12. Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
13. Unstable or untreated pre-existing psychiatric condition.
14. Any known pre-existing medical condition that could interfere with the subject?s participation in and completion of the study.
15. Any current evidence of substance abuse of alcohol or other drugs.
16.Subjects receiving Opiod Agonist substitution therapy but not enrolled in an opiate substitution maintenance progam.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method