NCT00941083UnknownPhase 4
Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
Hospital Carlos III, Madrid1 site in 1 country240 target enrollmentStarted: January 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD)
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
RAL QD 800 mg/24 hs
Experimental
Intervention: Raltegravir (Use RAL as a simplification strategy) (Drug)
RAL BID 400 mg/12 hs
Active Comparator
Intervention: Raltegravir (Use RAL as a simplification strategy) (Drug)
RAL BID to QD
Experimental
Intervention: Raltegravir (Use RAL as a simplification strategy) (Drug)
Outcomes
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)
Time Frame: 24 weeks
Secondary Outcomes
- CD4 gains, lipid profile, adverse events,(24 weeks)
- Drug resistance mutations(24 weeks)
- Raltegravir through plasma levels and correlation with virological failure(24 weeks)
Investigators
Study Sites (1)
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