Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4

January 29, 2008 updated by: Hospital Clinico Universitario San Cecilio

Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4

A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients.

The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment.

In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%.

The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment.

Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate efficacy of extend treatment during 24 weeks more in co-infected HIV-HCV patients with genotype 1 and/or 4 who at 44 week of treatment with peginterferón alfa-2a in combination with ribavirin have RNA-HCV undetectable.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Cádiz, Spain, 11009
        • Hospital Puerta del Mar
      • Granada, Spain, 18013
        • Hospital Clinico Universitario San Cecilio
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Sevilla, Spain, 41014
        • Hospital De Valme
      • Sevilla, Spain, 41008
        • Hospital Virgen Macarena
      • Valencia, Spain, 46014
        • Consorcio Hospital General
      • Valladolid, Spain, 47011
        • Hospital Clínico de Valladolid
    • Alava
      • Vitoria, Alava, Spain, 01009
        • Hospital de Txagorritxu
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital De Bellvitge
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Hospital de Jerez
    • Gran Canaria
      • Las Palmas, Gran Canaria, Spain, 35016
        • Hospital Insular
    • Guipúzcoa
      • San Sebastián, Guipúzcoa, Spain, 20014
        • Hospital de Donostia
    • La Coruña
      • Santiago, La Coruña, Spain, 15705
        • Complejo Hospitalario Universitario
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07014
        • Hospital Son Dureta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week
  • RNA-HCV positive at 48 week before study and genotype 1 or 4.
  • HIV-1 positive: ELISA y Western-blot.
  • Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study).
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
  • Willingness to give written informed consent and willingness to participate to and comply with the study.

Exclusion Criteria:

  • Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day).
  • Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described.
  • More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Experimental: 1
Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
Drug: Peginterferon alfa-2a + ribavirin
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% of patients with RNA-HCV undetectable
Time Frame: at 48 week of study (24 weeks after the end of treatment period of trial).
at 48 week of study (24 weeks after the end of treatment period of trial).

Secondary Outcome Measures

Outcome Measure
Time Frame
% of percentage of patients with RNA-HCV undetectable
Time Frame: 24 weeks of trial period
24 weeks of trial period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinico Universitario San Cecilio

Investigators

  • Study Chair: José Hernández-Quero, Dr, Hospital Clinico Universitario San Cecilio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2008

Last Update Submitted That Met QC Criteria

January 29, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Extrados
  • 2004-004948-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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