Randomized, controlled, multicentric trial to evaluate efficacy and safety of the switch from a LPV/r based therapy to an ATV/r or a NVP based treatment in association with ABC/3TC, in HIV patient with undetectable viral load

Phase 1

• Conditions: HIV infection; MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2006-006716-30-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-05
• Study Completion: 2010-08-30
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

?Male and female subjects between 18 and 65 years of age inclusive;
?Informed consent ;
?HIV-1 infected patients ;
?Actual treatment with a first/second line HAART with LPV/r and 2 NRTI longer than 6 months;
?Viral load suppression (HIV-1 <50 copies/ml) for at least 6 months before entry the study;
?Any CD4 count with the exception of women with more than 250 CD4/ml;
?Stable clinical conditions.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

?Incapacity to give/ maintain the informed consent;
?Active opportunistic disease, neoplasm, acute viral hepatitis, IDU, alcoholism;
?Previous NNRTI treatment discontinued for virologic failure;
?Previous treatment with NVP interrupted due to intolerance and/or toxicity;
?Previous treatment with ABC interrupted due to virologic failure, intolerance and/or toxicity;
?Female patient of child bearing potential who:
oHas a positive serum pregnancy test at screening or during the study,
oIs breast feeding,
oIs planning to become pregnant,
oIs not willing to use barrier method protection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the different incidence of virologic failure between the two groups after 12 months from randomization.;Secondary Objective: ?To evaluate after 12 months any changes of CD4+ and CD8+ (absolute value and percentage);<br>?To evaluate after 12 months any metabolic, morphologic lipodystrophic alteration;<br>?To evaluate after 12 months the alteration of the bone metabolism;Primary end point(s): ?Proportion of patients with HIV pVL <50 copies/ml in the two different groups.