Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
NCT ID: NCT00612755
Last Updated: 2008-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
43 participants
INTERVENTIONAL
2005-10-31
2008-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
Peginterferon alfa-2a + ribavirin
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
2
No interventions assigned to this group
Interventions
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Peginterferon alfa-2a + ribavirin
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Hospital Clinico Universitario San Cecilio
OTHER
Responsible Party
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Hospital Clinico Universitario San Cecilio
Principal Investigators
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José Hernández-Quero, Dr
Role: STUDY_CHAIR
Hospital Clínico Universitario San Cecilio
Locations
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Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain
Hospital Insular
Las Palmas, Gran Canaria, Spain
Hospital Clínico Universitario San Cecilio
Granada, Granada, Spain
Hospital de Donostia
San Sebastián, Guipúzcoa, Spain
Complejo Hospitalario Universitario
Santiago, La Coruña, Spain
Fundación Hospital de Alcorcón
Alcorcón, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital Son Dureta
Palma de Mallorca, Mallorca, Spain
Hospital Virgen Macarena
Seville, Sevilla, Spain
Hospital Virgen del Rocío
Seville, Sevilla, Spain
Hospital de Valme
Seville, Sevilla, Spain
Consorcio Hospital General
Valencia, Valencia, Spain
Hospital Clínico de Valladolid
Valladolid, Valladolid, Spain
Countries
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Other Identifiers
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2004-004948-45
Identifier Type: -
Identifier Source: secondary_id
Extrados
Identifier Type: -
Identifier Source: org_study_id
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