HIV Infections Clinical Trial
Official title:
A Multicenter, Randomized, Open Label, Pilot Study to Assess the Possibility of Concomitant Treatment of HCV/HIV co Infection With Peg-interferon + Ribavirin, and Lopinavir/r as a Single Antiretroviral Agent.
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.
Viral hepatitis, mainly when caused by the hepatitis C virus (HCV), is highly significant in
the setting of infection by the human immunodeficiency virus (HIV) because high activity
antiretroviral therapy (HAART) has a very favorable impact upon morbidity and mortality of
this disease. HAART has achieved disease control, significantly increasing survival and
improving the quality of life of subjects with HIV infection.
Spain has one of the highest prevalences of HIV-HCV co-infection because both HCV and HIV
infection are strongly associated to being or having been an intravenous drug user (IDU);
thus, from 61% to 69% of these subjects infected by HIV in Spain are also infected by HCV.
From 1998, standard treatment for chronic C hepatitis consists of the combination of
interferon alpha and ribavirin, based on an increased efficacy versus interferon
monotherapy; however, development of pegylated interferon, with a more convenient
bioavailability as compared to conventional interferon alpha, has allowed for developing
even more effective combined therapies and the possibility of improving response prediction
based on changes in viremia within the first few weeks of treatment. However, treatment of
HCV infection usually involves severe side effects, which often lead to treatment
discontinuation or to the need for adjusting drug dosage, in which case treatment efficacy
may decrease.
HCV+ subjects who, because of HIV co-infection, should also receive HAART, may have an
increased number or increased severity of adverse reactions due to interactions occurring
with drug co-administration.
Lopinavir/ritonavir (LPV/r) is a potent HIV protease inhibitor and is characterized by a
very high pharmacological and genetic barrier.
Different studies (subject cohorts, uncontrolled studies) during the past years have
appeared in the literature showing the efficacy of LPV/r or controlling viral replication.
Most studies were conducted with the soft gel capsule formulation of LPV/r. In this study,
the new formulation of LPV/r (Kaletra) as tablets approved by the FDA and EMEA (Spain
authorization 30th Oct 2006) will be used. This new formulation will provide additional
benefits to this strategy that has only been studied to date with soft gel capsules.
Based on the foregoing and on the additional cost savings involved in this strategy, we
think that LPV/r, as single antiretroviral agent concomitantly administered with treatment
for hepatitis C virus infection may provide significant benefits because it would prevent
interactions between NRTIs and ribavirin, thus being potentially able to decrease the
adverse events derived from mitochondrial toxicity and minimizing the possibility of anemia.
In addition, replacement of NNRTIs by LPV/r may significantly decrease CNS involvement that
may be enhanced by co-administration of efavirenz and peg-interferon, or minimize the risk
of hepatotoxicity caused by nevirapine.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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