chronic HIV infection MedDRA version: 9.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection
Conditions
Interventions
Trade Name: ISENTRESS
Pharmaceutical Form: Tablet
INN or Proposed INN: RALTEGRAVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
Trade Name: REYATAZ
Pharmac
Sponsors
AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Inclusion i. Age > 18 years ii. Documented chronic HIV infection iii. Signed informed consent iv. Effective ongoing treatment (HIV-RNA 300 mg/dl or TG > 400 mg) vi. No documented resistance to protease inhibitors Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: b. Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is:  To verify the reduction of lipid toxicity following an alternative HIV regimen in patients with lipid abnormalities secondary to current antiretrovirals.;Secondary Objective: Secondary objectives are to verify:  The persistence of virological efficacy (as HIV RNA levels below 50 copies/ml).  The persistence of immunological response (as CD4 count values).  The proportion of patients for whom lipid-lowering agents would be recommended according to National Education Cholesterol Program guidelines.  The absence of pharmacokinetic interactions between atazanavir and raltegravir.  The effect on adherence to medication after changing regimen.;Primary end point(s): The main end point of the study is the reduction of lipid abnormalities (total cholesterol and/or trygliceryde levels) following the change in drug regimen. The effect will be measured by the absolute variation in total cholesterol, LDL-C, HDL-C and triglyceride values. In addition, the variation in the proportion of patients for whom lipid-lowering agents would be recommended (according to National Education Cholesterol Program guidelines) will be evaluated after 24 weeks since therapy modification. The secondary objectives of the study will be mainly evaluated in a descriptive form. This will be the case for viro-immunological results at 24 weeks and for PK findings. These latter ones will be compared with historical data to confirm the absence of clinically relevant interactions. Adherence to medications will be compared at baseline and after 6 months in order to assess potential variations by mean of validated Visual Analogue Scale | — |
Countries
Italy
Outcome results
None listed