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Hepatitis CPhase 3NCT01467479

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

A Phase 3 study testing Telaprevir, Ribavirin and Pegylated Interferon Alfa-2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 59 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C
What is being tested?
Telaprevir, Ribavirin and Pegylated Interferon Alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
59 sitesin 5 countries
Study dates
Dec 2011to Feb 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

59 sites in 5 countries.

59 sites in 5 countries

United States46 sites

  • Georgia

    Atlanta, Georgia

  • California

    Bakersfield, California

  • Maryland

    Baltimore, Maryland

  • Florida

    Bay Pines, Florida

  • California

    Beverly Hills, California

  • Alabama

    Birmingham, Alabama

  • Illinois

    Chicago, Illinois

  • Ohio

    Cincinnati, Ohio

  • Ohio

    Cleveland, Ohio

  • South Carlonia

    Columbia, South Carolina

  • California

    Coronado, California

  • Texas

    Dallas, Texas

  • Georgia

    Decatur, Georgia

  • Michigan

    Detroit, Michigan

  • North Carolina

    Durham, North Carolina

  • Texas

    Houston, Texas

  • Florida

    Jacksonville, Florida

  • Missouri

    Kansas City, Missouri

  • California

    Los Angeles, California

  • Maryland

    Lutherville, Maryland

  • Florida

    Miami, Florida

  • Minnesota

    Minneapolis, Minnesota

  • Connecticut

    New Haven, Connecticut

  • New York

    New York, New York

  • New Jersey

    Newark, New Jersey

  • California

    Oakland, California

  • Florida

    Orlando, Florida

  • California

    Palo Alto, California

  • Pennsylvania

    Philadelphia, Pennsylvania

  • Maine

    Portland, Maine

  • Oregon

    Portland, Oregon

  • Rhode Island

    Providence, Rhode Island

  • Virginia

    Richmond, Virginia

  • New York

    Rochester, New York

  • California

    Sacremento, California

  • Utah

    Salt Lake City, Utah

  • California

    San Diego, California

  • California

    San Francisco, California

  • New Mexico

    Santa Fe, New Mexico

  • Washington

    Seattle, Washington

  • Massachusetts

    Springfield, Massachusetts

  • Missouri

    St Louis, Missouri

  • New York

    The Bronx, New York

  • DC

    Washington D.C., District of Columbia

  • Washington, DC

    Washington D.C., District of Columbia

  • Florida

    West Palm Beach, Florida

Other trials in United States

Canada5 sites

  • Edmonton

    Edmonton, Alberta

  • Hamilton

    Hamilton, Ontario

  • Montreal

    Montreal, Quebec

  • Toronto

    Toronto, Ontario

  • Vancouver

    Vancouver, British Columbia

Other trials in Canada

Germany4 sites

  • Bonn

    Bonn

  • Essen

    Essen

  • Hamburg

    Hamburg

  • Munchen

    München

Other trials in Germany

Spain3 sites

  • Spain

    Badalona

  • Barcelona

    Barcelona

  • Madrid

    Madrid

Other trials in Spain

Puerto Rico1 site

  • Puerto Rico

    San Juan

Other trials in Puerto Rico

About this study

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)

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
Being tested
Telaprevir, Ribavirin, Pegylated Interferon Alfa-2a, Highly Active Antiretroviral Therapy (HAART)
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelaprevirDrug

    Also called VX-950

    Tablet

  • RibavirinDrug

    Also called Copegus®, RBV

    Tablet

  • Pegylated Interferon Alfa-2aBiological

    Also called Pegasys®, Peg-IFN-Alfa-2a

    Subcutaneous Injection

  • 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.

Study groups in NCT01467479
Study groupRoleWhat they receive
T/PR + HAART Regimen (ATV/r-Based)ExperimentalParticipants 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.
Receives: Drug: Telaprevir; Drug: Ribavirin; Biological: Pegylated Interferon Alfa-2a; Drug: Highly Active Antiretroviral Therapy (HAART)
T/PR + HAART Regimen (EFV-Based)ExperimentalParticipants 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.
Receives: Drug: Telaprevir; Drug: Ribavirin; Biological: Pegylated Interferon Alfa-2a; Drug: Highly Active Antiretroviral Therapy (HAART)
T/PR + HAART Regimen (RAL-Based)ExperimentalParticipants 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.
Receives: Drug: Telaprevir; Drug: Ribavirin; Biological: Pegylated Interferon Alfa-2a; Drug: Highly Active Antiretroviral Therapy (HAART)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (7)

  1. 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 (<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).

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

  2. 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 (<lower limit of quantification) 4 weeks after the start of study treatment.

    Measured: Week 4

  3. 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 (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.

    Measured: Week 4 and Week 12

  4. 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 (<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.

    Measured: EOT (up to Week 48)

  5. 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.

    Measured: Up to Week 52

  6. Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)

    Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.

    Measured: Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir

  7. 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.

    Measured: Baseline, follow-up (Week 96)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Why it stopped: It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01467479
Sponsor's protocol ID
VX11-950-115
Status last verified
Mar 2015
First submitted
3 Nov 2011
Last updated
17 Mar 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telaprevir, Ribavirin and Pegylated Interferon Alfa-2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 59 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada, Germany, Spain, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) (time frame: 12 weeks after last planned dose of study drug (up to Week 60)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01467479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.

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