HIV Infections Clinical Trial
Official title:
Study ACA-ARGE-04-001 "A Pilot, Open-Label Study Assessing Safety, Tolerability, Efficacy of a Simplified Lopinavir/Ritonavir Induction/Maintenance Therapy in HIV-Infected Subjects on Their First Protease Inhibitor-Based Regimen".
This study will assess the safety, tolerability and antiviral activity of a simplified
PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients
infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.
The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide
spectrum of patients in a number of different clinical trials.6-9 The durable viral
suppression seen after 4 years of therapy10 proves that it can provide effective, long-term
treatment for people with HIV-1.
Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir
in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in
the treatment of HIV-1-infection.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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