Treatment of HIV/HCV Coinfection With Peg-IFN and Ribavirin in Patients Receiving ART Monotherapy… (NCT00866021) | Clinical Trial Compass
CompletedPhase 4
Treatment of HIV/HCV Coinfection With Peg-IFN and Ribavirin in Patients Receiving ART Monotherapy With Lopinavir/r
Spain68 participantsStarted 2008-02
Plain-language summary
The aim of this study is to assess the efficacy of lopinavir/r in monotherapy and peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject consent to participate in this study after being informed of all trial aspects that may influence his/her decision, given by signing and dating the informed consent form approved by the CREC of the corresponding center.
✓. Subject is at least 18 years old, is co-infected by HIV and HCV, and has been recommended treatment for HCV infection.
✓. Liver biopsy confirming the presence of chronic hepatitis performed within one year of patient entry into the study.
✓. Undetectable viral load (\<50 cop/mL) during at least the 6 last months (confirmed). At least two viral load determinations lower than 50 cop/mL 6 months apart are required. The inclusion of patients showing one single "blip" during the pre-enrollment past 6 months is allowed. A "blip" is defined as a HIV viral load greater or equal to 50 cop/mL both preceded and followed of viral loads inferior to 50 cop/mL without changes in the antiretroviral treatment.
✓. CD4 at screening should be at least or greater to 350 cells/microl
✓. Subject on continued, uninterrupted antiretroviral therapy for the past 6 months with
✓. LPV/r + 2 NRTIs/NtRTIs for at least 4 weeks;
✓. 1 NNRTI + 2 NRTIs
Exclusion criteria
✕. Subjects in whom a switch in protease inhibitor has ever been made due to suspected or documented virological failure.
✕. Subjects requiring treatment with drugs whose association with LPV/r is contraindicated based on Kaletra prescribing information..
What they're measuring
1
Assess efficacy of concomitant treatment with lopinavir/r monotherapy and PEG-INF plus RBV for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV
✕. Active drug addiction or psychiatric disease that may prevent protocol compliance. Use of cannabis or being on methadone treatment are excepted, provided protocol compliance is not compromised in the investigator's opinion.
✕. Pregnancy or nursing, and in women of childbearing age, if they do not agree to use throughout the study a barrier contraceptive method of proven reliability in the investigator's opinion.
✕. In the opinion of the principal investigator, patient is unlikely to comply with the study protocol, or the patient was not eligible for any other reason.
✕. Subjects infected by the hepatitis B virus and who are being treated with tenofovir (TDF) or lamivudine (3TC).
✕. Prior treatment with interferon (pegylated or not) and/or ribavirin.