HIV MedDRA version: 12.0 Level: HLT Classification code 10038997 Term: Retroviral infections
Conditions
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients treated with a combined antiretroviral therapy from at least 1 year Aged 18 years or older With one or more of the following conditions:  Grade 3 or 4 Dyslipidemia  Any Hyperglicemia  Lipodystrophy (patient?s self report, confirmed by physician?s physical examination)  Moderate/severe cardiovascular risk, defined as a calcium score higher than 40 or a Framingham score higher than 10 (estimated 10 years cardiovascular risk: 10%)  Diarrhea (at least 3 emissions of loose stool every day for at least 3 days every week) With at least two HIV-RNA levels 200 cells/ μL for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening. Who gave informed consent to the participation to the study 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or breast feeding, desire of pregnancy in the short term Previous virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues except for patients with subsequent genotypic resistance tests showing no resistance mutations to any of the study drugs. Previous exposure to inhibitors of HIV-1 integrase Previous major toxicity to any of the study drugs Spontaneous treatment interruptions in disagreement with the treating physician in the last year or loss to follow-up for at least 6 months, at least once in the last two years Current alcohol or drug abuse or any other condition which, in the judgment of the treating physician, may impair the patient?s adherence to the new drug regimen and/or to the protocol?s procedures Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid and glucose levels)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabina + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies;Secondary Objective:  Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis  Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis  Evolution of CD4 cell count during the 48 weeks of study  Evolution of adherence and quality of life during the 48 weeks of study  Evolution of raltegravir plasma concentrations during the 48 weeks of study  Evolution of metabolic parameters during the 48 weeks of study  Change of the results of neurocognitive tests at 48 weeks of study  Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study;Primary end point(s): proportion of patients with virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) within 48 weeks at intention-to.treat analysis | — |
Countries
Italy
Outcome results
None listed