drugset / Trial / NCT00661349

Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients

NCT00661349 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

In retrospective studies, acceleration of hepatic fibrosis has been seen in Nevirapine (NVP) treatment when compared with Protease Inhibitors (PI) boosted with ritonavir treatment in patients with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) infection. The high incidence in our country of HIV-HCV co-infection, the availability of a new Kaletra (LPV/r) formulation (more convenient and better tolerated than soft capsules) as well as the possibility of analyzing hepatic fibrosis evolution in a fast and bloodless way, make attractive a study that, in a prospective way, could check the benefits of substituting NVP by LPV/r on hepatic fibrosis in this community.

Timeline

Start
2008-02
Primary completion
2008-12
Completion
2008-12

Outcome

Outcome not reported

Stopped: “It has been impossible to achieve the number of patients defined by protocol”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lopinavir/ritonavir Unknown — —
Comparator Nevirapine Small molecule — —