Clinical trial NCT01467479: A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
timeFrame: 12 weeks after last planned dose of study drug (up to Week 60)
Secondary outcomes:
measure: Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
timeFrame: 24 weeks after last planned dose of study drug (up to Week 72)
measure: Percentage of Participants With Rapid Viral Response (RVR)
timeFrame: Week 4
measure: Percentage of Participants With Extended Rapid Viral Response (eRVR)
timeFrame: Week 4 and Week 12
measure: Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)
timeFrame: EOT (up to Week 48)
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 52
measure: Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
timeFrame: Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
measure: Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
timeFrame: Baseline, follow-up (Week 96)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama
state: Alabama
city: Bakersfield
country: United States
facility: California
state: California
city: Beverly Hills
country: United States
facility: California
state: California
city: Coronado
country: United States
facility: California
state: California
city: Los Angeles
country: United States
facility: California
state: California
city: Oakland
country: United States
facility: California
state: California
city: Palo Alto
country: United States
facility: California
state: California
city: Sacremento
country: United States
facility: California
state: California
city: San Diego
country: United States
facility: California
state: California
city: San Francisco
country: United States
facility: California
state: California
city: New Haven
country: United States
facility: Connecticut
state: Connecticut
city: Washington DC
country: United States
facility: DC
state: District of Columbia
city: Washington
country: United States
facility: Washington, DC
state: District of Columbia
city: Bay Pines
country: United States
facility: Florida
state: Florida
city: Jacksonville
country: United States
facility: Florida
state: Florida
city: Miami
country: United States
facility: Florida
state: Florida
city: Orlando
country: United States
facility: Florida
state: Florida
city: West Palm Beach
country: United States
facility: Florida
state: Florida
city: Atlanta
country: United States
facility: Georgia
state: Georgia
city: Decatur
country: United States
facility: Georgia
state: Georgia
city: Chicago
country: United States
facility: Illinois
state: Illinois
city: Portland
country: United States
facility: Maine
state: Maine
city: Baltimore
country: United States
facility: Maryland
state: Maryland
city: Lutherville
country: United States
facility: Maryland
state: Maryland
city: Springfield
country: United States
facility: Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Missouri
state: Missouri
city: Newark
country: United States
facility: New Jersey
state: New Jersey
city: Santa Fe
country: United States
facility: New Mexico
state: New Mexico
city: Bronx
country: United States
facility: New York
state: New York
city: New York
country: United States
facility: New York
state: New York
city: Rochester
country: United States
facility: New York
state: New York
city: Durham
country: United States
facility: North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Ohio
state: Ohio
city: Cleveland
country: United States
facility: Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon
state: Oregon
city: Philadelphia
country: United States
facility: Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island
state: Rhode Island
city: Columbia
country: United States
facility: South Carlonia
state: South Carolina
city: Dallas
country: United States
facility: Texas
state: Texas
city: Houston
country: United States
facility: Texas
state: Texas
city: Salt Lake City
country: United States
facility: Utah
state: Utah
city: Richmond
country: United States
facility: Virginia
state: Virginia
city: Seattle
country: United States
facility: Washington
state: Washington
city: Edmonton
country: Canada
facility: Edmonton
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Toronto
state: Ontario
city: Montreal
country: Canada
facility: Montreal
state: Quebec
city: Bonn
country: Germany
facility: Bonn
city: Essen
country: Germany
facility: Essen
city: Hamburg
country: Germany
facility: Hamburg
city: Munchen
country: Germany
facility: Munchen
city: San Juan
country: Puerto Rico
facility: Puerto Rico
city: Badalona
country: Spain
facility: Spain
city: Barcelona
country: Spain
facility: Barcelona
city: Madrid
country: Spain
facility: Madrid
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: