Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
- Conditions
- HIV InfectionsHepatitis C
- Interventions
- Drug: Peginterferon alfa-2a + ribavirin
- Registration Number
- NCT00612755
- Lead Sponsor
- Hospital Clinico Universitario San Cecilio
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Peginterferon alfa-2a + ribavirin Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
- Primary Outcome Measures
Name Time Method % of patients with RNA-HCV undetectable at 48 week of study (24 weeks after the end of treatment period of trial).
- Secondary Outcome Measures
Name Time Method % of percentage of patients with RNA-HCV undetectable 24 weeks of trial period
Trial Locations
- Locations (19)
Hospital de Jerez
🇪🇸Jerez de la Frontera, Cádiz, Spain
Hospital Insular
🇪🇸Las Palmas, Gran Canaria, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Hospital de Txagorritxu
🇪🇸Vitoria, Alava, Spain
Fundación Hospital de Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario
🇪🇸Santiago, La Coruña, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital Clínico Universitario San Cecilio
🇪🇸Granada, Spain
Consorcio Hospital General
🇪🇸Valencia, Spain
Hospital de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital de Donostia
🇪🇸San Sebastián, Guipúzcoa, Spain
Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Hospital de Valme
🇪🇸Sevilla, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain