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".

NCT00159224 Phase 4 COMPLETED

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.

Details

Lead sponsor	Fundación Huésped
Phase	Phase 4
Status	COMPLETED
Enrolment	100
Start date	2005-04
Completion	2009-12

Conditions

• HIV Infections

Interventions

• Lopinavir/ritonavir simplification strategy

Primary outcomes

• Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks — 48 weeks

Countries

Argentina, Canada, Mexico