Status:
COMPLETED
Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
Lead Sponsor:
Hospital Clinico Universitario San Cecilio
Conditions:
HIV Infections
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
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 ribavi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00612755
Start Date
October 1 2005
End Date
January 1 2008
Last Update
February 12 2008
Active Locations (19)
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1
Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, Spain, 01009
2
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
3
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
4
Hospital Puerta del Mar
Cadiz, Cádiz, Spain, 11009