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

NCT01467479 | Terminated Phase 3 Results DMC

• 1 other identifier: VX11-950-115
• Study Type: interventional
• Target: 185
• Locations: 5 countries
• Sites: 59

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 (\<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).

  12 weeks after last planned dose of study drug (up to Week 60)

Secondary Outcomes (7)

• Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)

  24 weeks after last planned dose of study drug (up to Week 72)

• Percentage of Participants With Rapid Viral Response (RVR)

  Week 4

• Percentage of Participants With Extended Rapid Viral Response (eRVR)

  Week 4 and Week 12

• Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)

  EOT (up to Week 48)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Week 52

Study Arms (3)

T/PR + HAART Regimen (ATV/r-Based)

EXPERIMENTAL

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.

Drug: Telaprevir; Drug: Ribavirin; Biological: Pegylated Interferon Alfa-2a; Drug: Highly Active Antiretroviral Therapy (HAART)

T/PR + HAART Regimen (EFV-Based)

EXPERIMENTAL

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.

Drug: Telaprevir; Drug: Ribavirin; Biological: Pegylated Interferon Alfa-2a; Drug: Highly Active Antiretroviral Therapy (HAART)

T/PR + HAART Regimen (RAL-Based)

EXPERIMENTAL

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.

Drug: Telaprevir; Drug: Ribavirin; Biological: Pegylated Interferon Alfa-2a; Drug: Highly Active Antiretroviral Therapy (HAART)

Interventions

Telaprevir DRUG

Tablet

Also known as: VX-950

T/PR + HAART Regimen (ATV/r-Based); T/PR + HAART Regimen (EFV-Based); T/PR + HAART Regimen (RAL-Based)

Ribavirin DRUG

Tablet

Also known as: Copegus®, RBV

T/PR + HAART Regimen (ATV/r-Based); T/PR + HAART Regimen (EFV-Based); T/PR + HAART Regimen (RAL-Based)

Pegylated Interferon Alfa-2a BIOLOGICAL

Subcutaneous Injection

Also known as: Pegasys®, Peg-IFN-Alfa-2a

T/PR + HAART Regimen (ATV/r-Based); T/PR + HAART Regimen (EFV-Based); T/PR + HAART Regimen (RAL-Based)

Highly Active Antiretroviral Therapy (HAART) DRUG

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 (ATV/r-Based); T/PR + HAART Regimen (EFV-Based); T/PR + HAART Regimen (RAL-Based)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (59)

Alabama

Birmingham, Alabama, United States

Location

California

Bakersfield, California, United States

Location

California

Beverly Hills, California, United States

Location

California

Coronado, California, United States

Location

California

Los Angeles, California, United States

Location

California

Oakland, California, United States

Location

California

Palo Alto, California, United States

Location

California

Sacremento, California, United States

Location

California

San Diego, California, United States

Location

California

San Francisco, California, United States

Location

Connecticut

New Haven, Connecticut, United States

Location

DC

Washington D.C., District of Columbia, United States

Location

Washington, DC

Washington D.C., District of Columbia, United States

Location

Florida

Bay Pines, Florida, United States

Location

Florida

Jacksonville, Florida, United States

Location

Florida

Miami, Florida, United States

Location

Florida

Orlando, Florida, United States

Location

Florida

West Palm Beach, Florida, United States

Location

Georgia

Atlanta, Georgia, United States

Location

Georgia

Decatur, Georgia, United States

Location

Illinois

Chicago, Illinois, United States

Location

Maine

Portland, Maine, United States

Location

Maryland

Baltimore, Maryland, United States

Location

Maryland

Lutherville, Maryland, United States

Location

Massachusetts

Springfield, Massachusetts, United States

Location

Michigan

Detroit, Michigan, United States

Location

Minnesota

Minneapolis, Minnesota, United States

Location

Missouri

Kansas City, Missouri, United States

Location

Missouri

St Louis, Missouri, United States

Location

New Jersey

Newark, New Jersey, United States

Location

New Mexico

Santa Fe, New Mexico, United States

Location

New York

New York, New York, United States

Location

New York

Rochester, New York, United States

Location

New York

The Bronx, New York, United States

Location

North Carolina

Durham, North Carolina, United States

Location

Ohio

Cincinnati, Ohio, United States

Location

Ohio

Cleveland, Ohio, United States

Location

Oregon

Portland, Oregon, United States

Location

Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Rhode Island

Providence, Rhode Island, United States

Location

South Carlonia

Columbia, South Carolina, United States

Location

Texas

Dallas, Texas, United States

Location

Texas

Houston, Texas, United States

Location

Utah

Salt Lake City, Utah, United States

Location

Virginia

Richmond, Virginia, United States

Location

Washington

Seattle, Washington, United States

Location

Edmonton

Edmonton, Alberta, Canada

Location

Vancouver

Vancouver, British Columbia, Canada

Location

Hamilton

Hamilton, Ontario, Canada

Location

Toronto

Toronto, Ontario, Canada

Location

Montreal

Montreal, Quebec, Canada

Location

Bonn

Bonn, Germany

Location

Essen

Essen, Germany

Location

Hamburg

Hamburg, Germany

Location

Munchen

München, Germany

Location

Puerto Rico

San Juan, Puerto Rico

Location

Spain

Badalona, Spain

Location

Barcelona

Barcelona, Spain

Location

Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevir; Ribavirin; peginterferon alfa-2a; Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Therapy, Combination; Drug Therapy; Therapeutics

Limitations and Caveats

It was decided by Sponsor on 13 January 2014 to terminate the study early at the primary efficacy endpoint (SVR12) as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.

Results Point of Contact

• Title: Medical Monitor
• Organization: Vertex Pharmaceuticals Incorporated

medicalinfo@vrtx.com

617-341-6777

Study Officials

• Medical Monitor

  Vertex Pharmaceuticals Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 8, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 17, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-03

Locations

CA (5); DE (4); US (46); PR (1); ES (3)