HIV Infections
Conditions
Keywords
Simplification from protease inhibitors to raltegravir, Treatment Experienced, HIV-1 Infections
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).
Interventions
DRUGRaltegravir (Use RAL as a simplification strategy)
RAL QD: RAL 800 mg/24 hs
Sponsors
Hospital Carlos III, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| CD4 gains, lipid profile, adverse events, | 24 weeks |
| Drug resistance mutations | 24 weeks |
| Raltegravir through plasma levels and correlation with virological failure | 24 weeks |
Countries
Spain
Outcome results
None listed