HIV infection MedDRA version: 12.0 Level: LLT Classification code 10008919 Term: Chronic HIV infection
Conditions
Sponsors
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At least 18 years; Receiving unchanged HAART regimen including two NRTIs and PI/boosted for at least 24 weeks; Plasma HIV-RNA 100 cell/mmc, and CD4>200 cell/mmc at screening. No previous history of suspected or confirmed virological failure while receiving a protease inhibitor; Signed and dated written informed consent. 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: History of virological failure defined as two consecutive plasma HIV-RNA >50 cp/ml while on previous or current antiretroviral therapy History of any primary PI mutations as defined by the IAS-USA guidelines 2008 Clinical or laboratory evidence of significantly decreased hepatic function or decompensation Diagnosis of acute viral hepatitis at screening Pregnant or breastfeeding woman Acute opportunistic infection requiring treatment (exclusion period: 30 days) Mycobacteriosis under treatment Malignancy requiring chemotherapy or radiotherapy Positive HBsAg HCV infection for which specific treatment is ongoing or planned during the first year on trial treatment. Contraindicated concomitant treatment Previous history of intolerance to LPV/r or DRV/RTV leading to treatment discontinuation Participation in another clinical trial with an on-going exclusion period at screening Subjects which in the opinion of the investigator is unable to complete the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of different maintenance strategies based on PI/r monotherapy (LPV/r or DRV/RTV) in HIV-1 infected persons with fully suppressive PI/r-based therapy.;Secondary Objective: To compare safety and tolerability of a treatment simplification regimen by a LPV/r or DRV/RTV monotherapy versus a triple PI-based combination therapy. To compare the immune response in terms of changes in the CD4 cell count from baseline over 48 weeks of a treatment simplification regimen by a LPV/r or DRV/RTV monotherapy with a triple PI-based combination therapy. To compare incidence of viral rebound in different treatment groups. To compare the frequency of development of at least one new mutations in RT and PR gene. To compare changes in HIV-DNA from baseline to 24, 48, and 96 weeks; To compare changes in laboratory parameters at all time points from baseline to 48 weeks in different treatment groups; To evaluate and compare the subject-reported adherence and quality of life (QoL) at baseline and the evolution of adherence and QoL over 48 weeks in treatment groups; To compare the antiretroviral drug treatment cost over 48 weeks in all treatment groups;Primary end point(s): Percentage of subjects with a plasma HIV-1 RNA <50 cp/ml at weeks 48 by intent to treat (ITT) analyses | — |
Countries
Italy
Outcome results
None listed