Studio degli effetti immuno-virologici dell’interruzione di Maraviroc nei pazienti che stanno fallendo un regime contenente Maraviroc

Phase 1

• Conditions: patients affected by HIV in stable treatment with Maraviroc from at least 6 months; MedDRA version: 14.1Level: LLTClassification code 10008922Term: Chronic infection with HIVSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-021651-79-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-13
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•age > 18 years •HIV infected, antiretroviral experienced patients •Stable HAART regimen containing maraviroc for at least 6 months •Confirmed (two consecutive determinations) HIV-1 RNA>50 copies/ml •Genotypic Sensitivity Score < equal to 1 (Patients without the possibility of constructing an effective HAART as recommended by guidelines)
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pregnancy and breast feeding women • Immediate availability of an effective HAART • Acute illness that in the opinion of the investigator might be aggravated by a partial interruption of antiretroviral treatment.

Study & Design

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