Simplification From Protease Inhibitors to Raltegravir (ODIS)
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ClinicalTrials.gov Identifier: NCT00941083
Verified September 2009 by Hospital Carlos III, Madrid. Recruitment status was: Recruiting
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).
Condition or disease
Drug: Raltegravir (Use RAL as a simplification strategy)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
HIV1 sero-positive using standard diagnostic criteria
Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization
On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry
Pregnancy or breast feeding
Prior use of Integrase inhibitors
Alcohol or substance abuse if according to the investigator opinion would interfere with compliance
UIse of investigational medications within 30 days before study entry or during the trial