Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)

NCT00941083 Phase 4 UNKNOWN

A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).

Details

Lead sponsor	Hospital Carlos III, Madrid
Phase	Phase 4
Status	UNKNOWN
Enrolment	240
Start date	2009-01
Completion	2009-12

Conditions

• HIV Infections

Interventions

• Raltegravir (Use RAL as a simplification strategy)
• Raltegravir (Use RAL as a simplification strategy)
• Raltegravir (Use RAL as a simplification strategy)

Primary outcomes

• Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD) — 24 weeks

Countries

Spain