An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)

Chronic Hepatitis C Clinical Trial

— INSIGHT  

Official title:

Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects With Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513941
• Other study ID #: CR100778
• Secondary ID: VX-950HPC3008201
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2012
• Last updated: May 4, 2016
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2016
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Australia: Department of Health and Ageing Therapeutic Goods AdministrationSpain: Ministry of Health and ConsumptionUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSweden: Medical Products AgencyGreat Britain: Medicines and Healthcare Products Regulatory AgencyGreat Britain: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).

Description:

This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic (detectable HCV Ribonucleic acid (RNA) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level greater than 1,000 IU/mL

• Confirmed diagnosis of HIV-1 infection greater than 6 months before the screening visit

• CD4 count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit

• HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit

• No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit

• Currently taking one of the permitted anti-HIV regimens for greater than or equal to12 weeks

Exclusion Criteria:

• Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period

• Infection or co-infection with HCV other than genotype 1

• Contraindication to the administration of Peg-IFN-alfa or RBV

• Hepatitis B virus (HBV) co-infection

• Acute or active condition of HIV-associated opportunistic infection within 6 months of screening

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Telaprevir
Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.
• Ribavirin
Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.
• Pegylated-Interferon-alfa-2a
Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Countries where clinical trial is conducted

Australia,  Brazil,  France,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels	Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.	Up to 48 weeks	No
Secondary	Change from baseline in log HCV RNA values	Change from baseline in log HCV RNA values at each time point during treatment.	Baseline and week 48	No
Secondary	Proportiond of patients achieving undetectable HCV RNA levels	Proportion of patients achieving SVR24 planned, defined as having undetectable plasma HCV RNA levels 24 weeks after the last planned dose of study medication.	Up to 48 weeks	No
Secondary	Proportion of patients achieving undetectable HCV RNA levels at Week 4	The proportion of patients who achieve rapid virologic response (RVR) and undetectable HCV RNA levels at Week 4 of treatment.	Up to 48 weeks	No
Secondary	Proportion of patients achieving undetectable HCV RNA levels at Week 12	Proportion of patients achieving undetectable HCV RNA levels at Week 12 of treatment.	Up to 48 weeks	No
Secondary	Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)	Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR).	Up to 48 weeks	No
Secondary	Proportion of patients achieving undetectable HCV RNA at the actual end of treatment	Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).	Up to 48 weeks	No
Secondary	Proportion of patients achieving less than 25 IU/mL	Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).	Up to 48 weeks	No
Secondary	Proportion of patients with on-treatment virologic failure	Proportion of patients with on-treatment virologic failure (an increase greater than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA greater than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).	Up to 48 weeks	No
Secondary	Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels	Proportion of patients who relapse (having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA levels (less than 25 IU/mL, undetectable) at planned end of treatment.	Up to 48 weeks	No
Secondary	Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels	Proportion of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.	Up to 48 weeks	No

External Links

•   Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated- Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects with Genotype 1 Chronic Hepatitis C and Human Immu(18137)