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

NCT ID: NCT01513941

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-06-30

Brief 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).

Detailed 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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV)

All patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 μg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV, Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Cairns, , Australia

Darlinghurst, , Australia

Melbourne, , Australia

Campinas, , Brazil

Rio de Janeiro, , Brazil

Santo André, , Brazil

São Paulo, , Brazil

Le Kremlin-Bicêtre, , France

Marseille, , France

Nice, , France

Paris, , France

Bydgoszcz, , Poland

Mysłowice, , Poland

Warsaw, , Poland

Krasnodar, , Russia

Perm, , Russia

Saint Petersburg, , Russia

Smolensk, , Russia

Voronezh, , Russia

Alicante, , Spain

Badalona, , Spain

Córdoba, , Spain

Donostia / San Sebastian, , Spain

Elche, , Spain

Madrid, , Spain

Seville, , Spain

Valencia, , Spain

Stockholm, , Sweden

Birmingham, , United Kingdom

Glasgow, , United Kingdom

London, , United Kingdom

Countries

Australia; Brazil; France; Poland; Russia; Spain; Sweden; United Kingdom

References

Montes ML, Nelson M, Girard PM, Sasadeusz J, Horban A, Grinsztejn B, Zakharova N, Rivero A, Durant J, Ortega-Gonzalez E, Lathouwers E, Janssen K, Ouwerkerk-Mahadevan S, Witek J, Gonzalez-Garcia J. Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study. J Antimicrob Chemother. 2016 Jan;71(1):244-50. doi: 10.1093/jac/dkv323. Epub 2015 Oct 19.

Reference Type: DERIVED

PMID: 26483516 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3446&filename=CR100778_CSR.pdf

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)

Other Identifiers

VX-950HPC3008

Identifier Type: OTHER

Identifier Source: secondary_id

2011-004928-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100778

Identifier Type: -

Identifier Source: org_study_id