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

NCT01513941 | Completed Phase 3

• 3 other identifiers: CR100778VX-950HPC30082011-004928-35
• Study Type: interventional
• Target: 163
• Locations: 8 countries
• Sites: 31

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).

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; Genotype 1 chronic hepatitis C; Treatment experienced with HCV-1/HIV-1 coinfection; Telaprevir; Pegylated-Interferon-alfa-2a; Ribavirin; HCV-1/HIV-1 coinfection; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change from baseline in log HCV RNA values

  Baseline and week 48

• Proportiond of patients achieving undetectable HCV RNA levels

  Up to 48 weeks

• Proportion of patients achieving undetectable HCV RNA levels at Week 4

  Up to 48 weeks

• Proportion of patients achieving undetectable HCV RNA levels at Week 12

  Up to 48 weeks

• Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)

  Up to 48 weeks

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated-Interferon-alfa-2a

Interventions

Telaprevir 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.

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

Ribavirin 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.

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

Pegylated-Interferon-alfa-2a 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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (31)

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Cairns, Australia

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Darlinghurst, Australia

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Melbourne, Australia

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Campinas, Brazil

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Rio de Janeiro, Brazil

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Santo André, Brazil

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São Paulo, Brazil

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Le Kremlin-Bicêtre, France

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Marseille, France

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Nice, France

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Paris, France

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Bydgoszcz, Poland

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Mysłowice, Poland

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Warsaw, Poland

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Krasnodar, Russia

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Perm, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Voronezh, Russia

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Alicante, Spain

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Badalona, Spain

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Córdoba, Spain

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Donostia / San Sebastian, Spain

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Elche, Spain

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Madrid, Spain

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Seville, Spain

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Valencia, Spain

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Stockholm, Sweden

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Birmingham, United Kingdom

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Glasgow, United Kingdom

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London, United Kingdom

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Related Publications (1)

• 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.

  PMID: 26483516 DERIVED

Related 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)

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

telaprevir; Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Janssen-Cilag International NV, Belgium Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

AU (3); BR (4); RU (5); FR (4); PL (3); GB (3); ES (8); SE (1)