Pilot study on efficacy of a simplification strategy from DRV/r 600/100 mg BID to DRV/r 800/100mg QD + OBT in HIV-positive patients HAART-experienced with virological response. - DRV-xp

Conditions: HIV infection
MedDRA version: 12.0Level: LLTClassification code 10020161Term: HIV infection

Registration Number: EUCTR2009-016705-42-IT

Lead Sponsor: ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

->18 years;
-Confirmed HIV-infection;
-Being on stable therapy with DRV/r 600/100mg BID + OBT from at least 6 months
-CD4+ >100 cellule/L at starting HAART and CD4> 200 cell/ml at scrrening.
-Confirmed HIV-1 RNA <40 cp/mL for at least 3 months while treated with DRV/r 600/100mg BID + OBT;
-No evidence of DRV-RAMS (resi stance associated mutations) at previous GRT
-Writen 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

-Previous virological failure (2 confirmed HIV-1 RNA VL>500 cp/ml) while on DRV/RTV-based therapy.
-Previous evidence of >3 DRV-RAMS (resistance- associeted mutations) according with IAS-USA guidelines 2008 (V11I, V32I, L33F, I47V, I50V, I84V, I54M/L, T74P, L76V, L89V)
-Intollerance to the drug used
Contraindicated concomitant treatment
-Subjects which in the opinion of the investigator is unable to complete the study period;
-Laboratory alterations:
oSGOT and SGPT ≥2,5 UNL;
ocreatinin >1,5 UNL;
oANC <1000/mm3;
oHb <10 g/dL;
oPLT <75.000/mm3;
-Clinically significant disease
-Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -Evaluate virological efficacy of a simplification strategy from DRV/r 600/100 mg BID to DRV/r 800/100mg QD + OBT in HIV-positive patients HAART-experienced with virological response.;Secondary Objective: -To evaluate safety and tolerability of DRV/r 800/100 mg in experienced-patients<br>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;<br>-To compare the antiretroviral drug treatment cost over 48 weeks;Primary end point(s): Percentage of subjects with < 40 cp/ml at Week 48

Secondary Outcome Measures