pazienti HIV-1 positivi MedDRA version: 6.1 Level: PT Classification code 10000565
Conditions
Interventions
Trade Name: VIRAMUNE*60 CPR 200 MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Nevirapine
CAS Number: 129618-40-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
FONDAZIONE NADIR ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV-1 documented infection Age 18 and 65 years Current therapy with a HAART including 1 PI ritonavir and 2 NRTIs Any CD4 cell count see exclusion criteria for female patients Plasma HIV-RNA 50 copies/mL for at least 6 months before randomization Stable clinical conditions 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: Active opportunistic infections, neoplasms, acute viral hepatitis, drug or alcohol abuse. Chronic hepatitis caused by HBV od HCV is not a cause for exclusion CD4 cell count 250 cells/microliter in female subjects Unability to give and/or to maintain an informed consent Previous NNRTI treatment that was discontinued due to virologic failure Previous nevirapine treatment that was discontinued due to intolerance and/or toxicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if there is a different incidence of virologic failure rate in the two groups after a 12-month follow-up;Secondary Objective: Evaluation of the frequence of adverse events in the two groups Evaluation of CD4 cell absolute number variation in the two groups Evaluation of the frequence of grade 3-4 DAIDS scale of clinical and laboratory adverse events in the two groups;Primary end point(s): Proportion of patients with plasma HIV viremia HIV-RNA below the limit of detection 50 copies/mL in the two groups at 12 months | — |
Countries
Italy
Outcome results
None listed