A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1
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ClinicalTrials.gov Identifier: NCT01479868 |
Recruitment Status
:
Completed
First Posted
: November 28, 2011
Results First Posted
: October 29, 2014
Last Update Posted
: October 29, 2014
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Condition or disease | Intervention/treatment | Phase |
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Hepatitis C Virus Genotype-1 | Drug: TMC435 Drug: Pegylated interferon alpha-2a Drug: Ribavirin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 109 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNα-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency Virus Type 1 (HIV-1) |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
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Experimental: TMC435 + pegylated interferon alpha-2a + ribavirin
Patients will be administered TMC435 150 mg along with pegylated interferon alpha-2a 180 microgram and ribavirin 1000 or 1200 mg for 12 weeks. Pegylated interferon alpha-2a and ribavirin will only be continued until 24 to 48 weeks.
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Drug: TMC435
TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.
Drug: Pegylated interferon alpha-2a
Pegylated interferon alpha-2a 180 microgram will be administered as subcutaneous injection of 0.5 mL until 24 to 48 weeks.
Drug: Ribavirin
Ribavirin 1000 or 1200 mg twice daily will be administered each day until 24 to 48 weeks.
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- Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12) [ Time Frame: 12 weeks after end of treatment (Week 24 or 48) ]The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment.
- Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24) [ Time Frame: 24 weeks after end of treatment (Week 24 or 48) ]The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.
- Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable [ Time Frame: Week 4, 12, 24, 36, and 48 ]Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.
- Percentage of Participants With On-treatment Failure [ Time Frame: Week 1 to 48 ]Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.
- Percentage of Participants With Viral Breakthrough [ Time Frame: Week 1 to 48 ]Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.
- Percentage of Participants With Viral Relapse [ Time Frame: Week 1 to 72 ]Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.
- Percentage of Participants With Normalized Alanine Aminotransferase Levels [ Time Frame: Baseline up to Week 72 ]Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.
- Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure [ Time Frame: Baseline to Week 72. ]Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.
- Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load [ Time Frame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72 ]
- Mean Change From Baseline in CD4+ Cell Count [ Time Frame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72 ]
- Change From Baseline in CD4+ Cell Count in Percentage [ Time Frame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72 ]
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Week 1 to Week 72 ]An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A liver biopsy required within 3 years prior to screening unless the patient has a contraindication for a liver biopsy
- Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within 2 years prior screening must have an ultrasound taken within 2 months prior to the screening visit or during screening with no findings suspicious for hepatocellular carcinoma (HCC)
- Genotype-1 hepatitis C virus (HCV) infection
- Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
- Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months prior to screening
Exclusion Criteria:
- Patient showing evidence of hepatic decompensation (ie, history or current evidence of ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international normalized ratio [INR] more than 1.5)
- Any liver disease of non-HCV etiology
- Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
- An acute HIV-1 infection; or HIV-2 infection
- Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479868

Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen R&D Ireland |
ClinicalTrials.gov Identifier: | NCT01479868 History of Changes |
Obsolete Identifiers: | NCT01727323 |
Other Study ID Numbers: |
CR018334 TMC435-TiDP16-C212 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | November 28, 2011 Key Record Dates |
Results First Posted: | October 29, 2014 |
Last Update Posted: | October 29, 2014 |
Last Verified: | October 2014 |
Keywords provided by Janssen R&D Ireland:
Hepatitis C virus genotype-1 Human immunodeficiency virus-type 1 HCV-1 HIV-1 TMC435 Pegylated interferon alpha-2a |
PegIFNα-2a Pegasys Ribavirin RBV Copegus |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Immunologic Deficiency Syndromes Hepatitis C, Chronic Acquired Immunodeficiency Syndrome HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Immune System Diseases Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Interferons Ribavirin Interferon-alpha Peginterferon alfa-2a Simeprevir Antineoplastic Agents Antiviral Agents Anti-Infective Agents |