A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
NCT ID: NCT01467479
Last Updated: 2015-03-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
185 participants
INTERVENTIONAL
2011-12-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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T/PR + HAART Regimen (ATV/r-Based)
Participants who were receiving atazanavir/ritonavir (ATV/r) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
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.
T/PR + HAART Regimen (EFV-Based)
Participants who were receiving efavirenz (EFV) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet three times a day for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
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.
T/PR + HAART Regimen (RAL-Based)
Participants who were receiving raltegravir (RAL) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
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.
Interventions
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Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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Alabama
Birmingham, Alabama, United States
California
Bakersfield, California, United States
California
Beverly Hills, California, United States
California
Coronado, California, United States
California
Los Angeles, California, United States
California
Oakland, California, United States
California
Palo Alto, California, United States
California
Sacremento, California, United States
California
San Diego, California, United States
California
San Francisco, California, United States
Connecticut
New Haven, Connecticut, United States
DC
Washington D.C., District of Columbia, United States
Washington, DC
Washington D.C., District of Columbia, United States
Florida
Bay Pines, Florida, United States
Florida
Jacksonville, Florida, United States
Florida
Miami, Florida, United States
Florida
Orlando, Florida, United States
Florida
West Palm Beach, Florida, United States
Georgia
Atlanta, Georgia, United States
Georgia
Decatur, Georgia, United States
Illinois
Chicago, Illinois, United States
Maine
Portland, Maine, United States
Maryland
Baltimore, Maryland, United States
Maryland
Lutherville, Maryland, United States
Massachusetts
Springfield, Massachusetts, United States
Michigan
Detroit, Michigan, United States
Minnesota
Minneapolis, Minnesota, United States
Missouri
Kansas City, Missouri, United States
Missouri
St Louis, Missouri, United States
New Jersey
Newark, New Jersey, United States
New Mexico
Santa Fe, New Mexico, United States
New York
New York, New York, United States
New York
Rochester, New York, United States
New York
The Bronx, New York, United States
North Carolina
Durham, North Carolina, United States
Ohio
Cincinnati, Ohio, United States
Ohio
Cleveland, Ohio, United States
Oregon
Portland, Oregon, United States
Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island
Providence, Rhode Island, United States
South Carlonia
Columbia, South Carolina, United States
Texas
Dallas, Texas, United States
Texas
Houston, Texas, United States
Utah
Salt Lake City, Utah, United States
Virginia
Richmond, Virginia, United States
Washington
Seattle, Washington, United States
Edmonton
Edmonton, Alberta, Canada
Vancouver
Vancouver, British Columbia, Canada
Hamilton
Hamilton, Ontario, Canada
Toronto
Toronto, Ontario, Canada
Montreal
Montreal, Quebec, Canada
Bonn
Bonn, , Germany
Essen
Essen, , Germany
Hamburg
Hamburg, , Germany
Munchen
München, , Germany
Puerto Rico
San Juan, , Puerto Rico
Spain
Badalona, , Spain
Barcelona
Barcelona, , Spain
Madrid
Madrid, , Spain
Countries
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Other Identifiers
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VX11-950-115
Identifier Type: -
Identifier Source: org_study_id
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