chronic HIV infection MedDRA version: 12.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV
Conditions
Interventions
Trade Name: KALETRA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
SIMIT sezione Regione Lombardia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age over or equal to 18; HIV infection in stable treatment con PI and nucleosidic analogs from at least 6 months; HIV-RNA=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: nadir linfocyte CD4+ <50/?l, previous failure to PI etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the reduction of annual cost for the patient treated with a monotherapy with lopinavir/r vs standard care (SOC,combination of 3 different drugs);Secondary Objective: evaluation and comparison between the 2 arms of the study: incidence of virologic failure in the period of 3 years; virologic response to a subsequent therapy in case of virologic failure; distribution during the time of virologic failures; etc..;Primary end point(s): average of annual cost/benefit in patients treated with monotherapy vs SC. | — |
Countries
Italy
Outcome results
None listed