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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Simplification
Helios Salud
Buenos Aires, Argentina
Fundacion Huesped
Buenos Aires, Argentina
University of British Columbia
Vancouver, British Columbia, Canada
Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán
Mexico City, Mexico
Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks
Time frame: 48 weeks
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