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Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens

Primary Purpose

Hepatitis C, HIV Infections

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week

Ribavirin (Copegus®) 1600 mg/day

Epoetin β (450 UI/kg/week)

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Ribavirin, non-responders, HCV co-infected patients, sustained virological response, Treatment Experienced

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

HIV-infected patients coinfected with HCV genotypes 1 or 4
Persistent transaminase elevation
Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d.

Exclusion Criteria:

Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
Patients with Child-Pugh B or C cirrhosis

Sites / Locations

Hospital Germans Trias i Pujol
Hospital del Mar

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)

Outcomes

Primary Outcome Measures

Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL

Secondary Outcome Measures

Changes in serum HCV-RNA titers

Percentage of patients with serum HCV-RNA loads of < 50 IU/mL

Full Information

NCT ID

NCT00470210

First Posted

May 4, 2007

Last Updated

December 3, 2019

Sponsor

Germans Trias i Pujol Hospital

Collaborators

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

1. Study Identification

Unique Protocol Identification Number

NCT00470210

Brief Title

Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens

Official Title

Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Germans Trias i Pujol Hospital

Collaborators

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.

Detailed Description

The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d. The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d. The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of < 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.

6. Conditions and Keywords

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

Hepatitis C, HIV Infections

Keywords

Ribavirin, non-responders, HCV co-infected patients, sustained virological response, Treatment Experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)

Intervention Type

Drug

Intervention Name(s)

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week

Intervention Description

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week

Intervention Type

Drug

Intervention Name(s)

Ribavirin (Copegus®) 1600 mg/day

Intervention Description

Ribavirin (Copegus®) 1600 mg/day

Intervention Type

Drug

Intervention Name(s)

Epoetin β (450 UI/kg/week)

Intervention Description

Epoetin β (450 UI/kg/week)

Primary Outcome Measure Information:

Title

Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL

Time Frame

24 weeks after finishing treatment

Secondary Outcome Measure Information:

Title

Changes in serum HCV-RNA titers

Time Frame

between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment

Title

Percentage of patients with serum HCV-RNA loads of < 50 IU/mL

Time Frame

at weeks 4, 8, 12, 24, and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HIV-infected patients coinfected with HCV genotypes 1 or 4 Persistent transaminase elevation Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d. Exclusion Criteria: Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks Patients with Child-Pugh B or C cirrhosis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bonaventura Clotet, MD, PhD

Organizational Affiliation

Germans Trias i Pujol Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cristina Tural, MD, PhD

Organizational Affiliation

Germans Trias i Pujol Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens

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