Hepatitis C, HIV Infections
Conditions
Keywords
chronic hepatitis C, co-infection, extend treatment, co-infected HIV-HCV
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.
Interventions
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Sponsors
Hospital Clinico Universitario San Cecilio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of patients with RNA-HCV undetectable | at 48 week of study (24 weeks after the end of treatment period of trial). |
Secondary
| Measure | Time frame |
|---|---|
| % of percentage of patients with RNA-HCV undetectable | 24 weeks of trial period |
Countries
Spain
Outcome results
None listed