Documented HIV infection
Conditions
Interventions
Trade Name: ISENTRESS
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Raltegravir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Trade Name: REYATAZ
Sponsors
AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Age > 18 years ii. Documented HIV infection iii. Written informed consent iv. Antiretroviral experienced patients v. Effective ongoing treatment (HIV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours ii. Any ongoing grade 4 laboratory abnormality, but for lipid alterations iii. Patients requiring chronic proton pump inhibitors. iv. Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit. v. History or suspected poor adherence to HAART.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective:  The persistence of virological efficacy (as HIV RNA levels below 50 copies/ml).;Secondary Objective:  The persistence of immunological response (as CD4 count values).  The absence of pharmacokinetic interactions between atazanavir and raltegravir.  The proportion of patients for whom lipid-lowering agents would be recommended according to National Education Cholesterol Program guidelines.  The effect on adherence to medication after changing the HIV regimen.;Primary end point(s): The main end point of the study is the persistence of virological efficacy (as HIV RNA levels below 50 copies/ml) following the change in drug regimen. In addition, the persistence of immunological response (as CD4 count values) and the absence of pharmacokinetic interactions between atazanavir and raltegravir will be evaluated. These latter ones will be compared with historical data to confirm the absence of clinically relevant interactions. Finally, the variations of lipid values (cholesterol and trygliceryde levels) will be evaluated after the switch. Adherence to medications will be compared at baseline and after 6 and 12 months in order to assess any potential variations by mean of validated Visual Analogue Scale | — |
Countries
Italy
Outcome results
None listed