A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

Hepatitis C Clinical Trial

Official title:

An Open Label,Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01467479
• Other study ID #: VX11-950-115
• Status: Terminated
• Phase: Phase 3
• First received: November 3, 2011
• Last updated: March 3, 2015
• Start date: December 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 185
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (>) 1000 international units per milliliter (IU/mL)

• Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse

• Population B: Peg-IFN/RBV prior null or partial responder

• Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration

• Participant must have positive HIV antibody at Screening

• Participant must have a diagnosis of HIV-1 infection >6 months before Screening

• Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening:

• Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine)

• Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components

• Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components

• Boosted atazanavir plus Epzicom®, or equivalent components

• Raltegravir plus Truvada®, or equivalent components

• Raltegravir plus Epzicom®, or equivalent components

• Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol

• Laboratory values within acceptable ranges at Screening as specified in the protocol

Exclusion Criteria:

• Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1

• Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides

• Contraindications to any planned HAART component as per the respective drug labeling information

• Contraindications to Peg-IFN or RBV

• Evidence of hepatic decompensation

• Clinical suspicion of acute hepatitis

• Any other cause of liver disease in addition to hepatitis C

• History of organ transplantation (except cornea and skin)

• Autoimmune-mediated disease

• Participated in any investigational drug study within 90 days before Day 1

• Previous treatment with an HCV protease inhibitor

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Telaprevir
Tablet
• Ribavirin
Tablet

Biological:
• Pegylated Interferon Alfa-2a
Subcutaneous Injection

Drug:
• Highly Active Antiretroviral Therapy (HAART)
Atazanavir/ritonavir (ATV/r) based HAART, Efavirenz (EFV) based HAART, or Raltegravir (RAL) based HAART, as per standard practice. HAART medications were not considered study drugs.

Locations

Country	Name	City	State
Canada	Edmonton	Edmonton	Alberta
Canada	Hamilton	Hamilton	Ontario
Canada	Montreal	Montreal	Quebec
Canada	Toronto	Toronto	Ontario
Canada	Vancouver	Vancouver	British Columbia
Germany	Bonn	Bonn
Germany	Essen	Essen
Germany	Hamburg	Hamburg
Germany	Munchen	Munchen
Puerto Rico	Puerto Rico	San Juan
Spain	Spain	Badalona
Spain	Barcelona	Barcelona
Spain	Madrid	Madrid
United States	Georgia	Atlanta	Georgia
United States	California	Bakersfield	California
United States	Maryland	Baltimore	Maryland
United States	Florida	Bay Pines	Florida
United States	California	Beverly Hills	California
United States	Alabama	Birmingham	Alabama
United States	New York	Bronx	New York
United States	Illinois	Chicago	Illinois
United States	Ohio	Cincinnati	Ohio
United States	Ohio	Cleveland	Ohio
United States	South Carlonia	Columbia	South Carolina
United States	California	Coronado	California
United States	Texas	Dallas	Texas
United States	Georgia	Decatur	Georgia
United States	Michigan	Detroit	Michigan
United States	North Carolina	Durham	North Carolina
United States	Texas	Houston	Texas
United States	Florida	Jacksonville	Florida
United States	Missouri	Kansas City	Missouri
United States	California	Los Angeles	California
United States	Maryland	Lutherville	Maryland
United States	Florida	Miami	Florida
United States	Minnesota	Minneapolis	Minnesota
United States	Connecticut	New Haven	Connecticut
United States	New York	New York	New York
United States	New Jersey	Newark	New Jersey
United States	California	Oakland	California
United States	Florida	Orlando	Florida
United States	California	Palo Alto	California
United States	Pennsylvania	Philadelphia	Pennsylvania
United States	Maine	Portland	Maine
United States	Oregon	Portland	Oregon
United States	Rhode Island	Providence	Rhode Island
United States	Virginia	Richmond	Virginia
United States	New York	Rochester	New York
United States	California	Sacremento	California
United States	Missouri	Saint Louis	Missouri
United States	Utah	Salt Lake City	Utah
United States	California	San Diego	California
United States	California	San Francisco	California
United States	New Mexico	Santa Fe	New Mexico
United States	Washington	Seattle	Washington
United States	Massachusetts	Springfield	Massachusetts
United States	Washington, DC	Washington	District of Columbia
United States	DC	Washington DC	District of Columbia
United States	Florida	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)	SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (	12 weeks after last planned dose of study drug (up to Week 60)	No
Secondary	Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)	SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (	24 weeks after last planned dose of study drug (up to Week 72)	No
Secondary	Percentage of Participants With Rapid Viral Response (RVR)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (	Week 4	No
Secondary	Percentage of Participants With Extended Rapid Viral Response (eRVR)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (	Week 4 and Week 12	No
Secondary	Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (	EOT (up to Week 48)	No
Secondary	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.	Up to Week 52	Yes
Secondary	Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)	Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.	Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir	No
Secondary	Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region	Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.	Baseline, follow-up (Week 96)	No