HIV INFECTION MedDRA version: 9.1 Level: HLT Classification code 10052740 Term: Acquired immunodeficiency syndromes
Conditions
Interventions
Trade Name: VIRAMUNE*60CPR 200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Nevirapine
CAS Number: 129618-40-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
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. Informed consent signed iii. Being naive for ARV therapy iv. CD4 cell count nadir and current CD4 count > 200 cells/L 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: i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviors ii. Any ongoing grade 4 laboratory abnormality iii. Previous diagnosis of AIDS iv. Active HBV co-infection v. Previous HIV-related AEs such as, but not limited to thrombocytopenia (platelets < 10.000/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective:  To compare immunologic, virologic and clinical efficacy and safety of a conventional HAART in chronically infected HIV patients to a therapeutic strategy based on long term, immunologically driven treatment interruptions.  To verify the feasibility of an STI strategy in patients starting their first line HAART regimen with CD4 < 200 cells/l;Secondary Objective:  To verify the effect of the two strategies on metabolic parameters  To verify the STI strategy feasibility on the basis of baseline CD4 counts  To identify predictive variables of the possibility to safely discontinue antiretroviral therapy and to prolong the off-therapy time  To verify the dynamics of CD4 T-cell loss and HIV replication after treatment interruption  To verify the genotypic characteristics of rebounding viruses in the STI arms  To verify adherence and quality of life induced by the two strategies  To analyze costs of the two therapeutic strategies  To analyze in nested studies, several specific variables such as mitocondrial damage or the effect on immune-reconstruction;Primary end point(s): The primary end-point aimed to evaluate how many and which kind of patients starting first-line HAART may perform an STI will be evaluated on the proportion of patients that will actually reach the required criteria to be randomized. The statistical population is therefore constituted, in this case, by all enrolled patients. The same population will be used to asses which baseline characteristics are predictive of the possibility to perform an STI program. ITT (true) analysis will be performed. The evaluation of the primary clinical, immunological and virological objective of the study will be evaluated on a statistical population constituted by all patients reaching the requested criteria for randomization, The same population will be used to analyze the secondary objective of the tria | — |
Countries
Italy
Outcome results
None listed