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

Primary Purpose

Hepatitis C

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telaprevir
Ribavirin
Pegylated Interferon Alfa-2a
Highly Active Antiretroviral Therapy (HAART)
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama
  • California
  • California
  • California
  • California
  • California
  • California
  • California
  • California
  • California
  • Connecticut
  • DC
  • Washington, DC
  • Florida
  • Florida
  • Florida
  • Florida
  • Florida
  • Georgia
  • Georgia
  • Illinois
  • Maine
  • Maryland
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Missouri
  • Missouri
  • New Jersey
  • New Mexico
  • New York
  • New York
  • New York
  • North Carolina
  • Ohio
  • Ohio
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carlonia
  • Texas
  • Texas
  • Utah
  • Virginia
  • Washington
  • Edmonton
  • Vancouver
  • Hamilton
  • Toronto
  • Montreal
  • Bonn
  • Essen
  • Hamburg
  • Munchen
  • Puerto Rico
  • Spain
  • Barcelona
  • Madrid

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

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

T/PR + HAART Regimen (EFV-Based)

T/PR + HAART Regimen (RAL-Based)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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.
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.
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.
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.

Full Information

First Posted
November 3, 2011
Last Updated
March 3, 2015
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01467479
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T/PR + HAART Regimen (ATV/r-Based)
Arm Type
Experimental
Arm Description
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.
Arm Title
T/PR + HAART Regimen (EFV-Based)
Arm Type
Experimental
Arm Description
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.
Arm Title
T/PR + HAART Regimen (RAL-Based)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
VX-950
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®, RBV
Intervention Description
Tablet
Intervention Type
Biological
Intervention Name(s)
Pegylated Interferon Alfa-2a
Other Intervention Name(s)
Pegasys®, Peg-IFN-Alfa-2a
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Highly Active Antiretroviral Therapy (HAART)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
Description
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).
Time Frame
12 weeks after last planned dose of study drug (up to Week 60)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
Description
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).
Time Frame
24 weeks after last planned dose of study drug (up to Week 72)
Title
Percentage of Participants With Rapid Viral Response (RVR)
Description
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.
Time Frame
Week 4
Title
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Description
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.
Time Frame
Week 4 and Week 12
Title
Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)
Description
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.
Time Frame
EOT (up to Week 48)
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Week 52
Title
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
Description
Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.
Time Frame
Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
Title
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Description
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.
Time Frame
Baseline, follow-up (Week 96)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Alabama
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
California
City
Bakersfield
State/Province
California
Country
United States
Facility Name
California
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
California
City
Coronado
State/Province
California
Country
United States
Facility Name
California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
California
City
Oakland
State/Province
California
Country
United States
Facility Name
California
City
Palo Alto
State/Province
California
Country
United States
Facility Name
California
City
Sacremento
State/Province
California
Country
United States
Facility Name
California
City
San Diego
State/Province
California
Country
United States
Facility Name
California
City
San Francisco
State/Province
California
Country
United States
Facility Name
Connecticut
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
DC
City
Washington DC
State/Province
District of Columbia
Country
United States
Facility Name
Washington, DC
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Florida
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
Florida
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
Florida
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Florida
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Georgia
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Georgia
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Illinois
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Maine
City
Portland
State/Province
Maine
Country
United States
Facility Name
Maryland
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Maryland
City
Lutherville
State/Province
Maryland
Country
United States
Facility Name
Massachusetts
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Michigan
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Missouri
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Missouri
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
New Jersey
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
New Mexico
City
Santa Fe
State/Province
New Mexico
Country
United States
Facility Name
New York
City
Bronx
State/Province
New York
Country
United States
Facility Name
New York
City
New York
State/Province
New York
Country
United States
Facility Name
New York
City
Rochester
State/Province
New York
Country
United States
Facility Name
North Carolina
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Ohio
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Ohio
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Oregon
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Rhode Island
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
South Carlonia
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Texas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Texas
City
Houston
State/Province
Texas
Country
United States
Facility Name
Utah
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Virginia
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Washington
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Edmonton
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Vancouver
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Hamilton
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Toronto
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Bonn
City
Bonn
Country
Germany
Facility Name
Essen
City
Essen
Country
Germany
Facility Name
Hamburg
City
Hamburg
Country
Germany
Facility Name
Munchen
City
Munchen
Country
Germany
Facility Name
Puerto Rico
City
San Juan
Country
Puerto Rico
Facility Name
Spain
City
Badalona
Country
Spain
Facility Name
Barcelona
City
Barcelona
Country
Spain
Facility Name
Madrid
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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