Simplification From Protease Inhibitors to Raltegravir
Phase 4
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00941083
- Lead Sponsor
- Hospital Carlos III, Madrid
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RAL QD 800 mg/24 hs Raltegravir (Use RAL as a simplification strategy) - RAL BID 400 mg/12 hs Raltegravir (Use RAL as a simplification strategy) - RAL BID to QD Raltegravir (Use RAL as a simplification strategy) -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method CD4 gains, lipid profile, adverse events, 24 weeks Drug resistance mutations 24 weeks Raltegravir through plasma levels and correlation with virological failure 24 weeks
Trial Locations
- Locations (1)
Hospital Carlos III
🇪🇸Madrid, Spain