Trials / Unknown
UnknownNCT00941083
Simplification From Protease Inhibitors to Raltegravir
Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Hospital Carlos III, Madrid · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Raltegravir (Use RAL as a simplification strategy) | RAL QD: RAL 800 mg/24 hs |
| DRUG | Raltegravir (Use RAL as a simplification strategy) | RAL BID 400 mg/12 hs |
| DRUG | Raltegravir (Use RAL as a simplification strategy) | RAL BID to QD |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2009-07-17
- Last updated
- 2009-09-10
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT00941083. Inclusion in this directory is not an endorsement.