HIV MedDRA version: 9.1 Level: LLT Classification code 10020443 Term: Human immunodeficiency virus syndrome
Conditions
Interventions
Trade Name: EPIVIR
Pharmaceutical Form: Tablet
INN or Proposed INN: Lamivudine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: NORVIR
Pharmaceutic
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients treated with a stable regimen including 2NRTIs + ATV/r for at least 6 months Aged 18 years or older 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 to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues. Previous major toxicity to any of the study drugs Patients with insufficient atazanavir plasma concentration (lower than 0.23 μg/mL at 12 2 hours or 0.15 μg/mL at 24 2 hours post-dosing) at screening Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid levels) Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications (as per product information) Detection of HBsAg in plasma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To verify the safety of the study treatment, defined as the persistent control of the virus replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir;Secondary Objective: To collect relevant informations about the safety and the metabolic impact of this strategy.;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