STUDY ABOUT THE USE OF THE TECHNIQUE FOR DETERMINING HIV TROPISM IN PATIENTS WITH UNDETECTABLE VIRAL LOAD TO GUIDE TREATMENT WITH A CCR5-ANTAGONIST DRUG.

Conditions: Human immunodeficiency virus (HIV) infection.
MedDRA version: 14.0Level: LLTClassification code 10008922Term: Chronic infection with HIVSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-000799-32-ES

Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

Adult (18 years or more), HIV-1 infected patients.
Antiretroviral treatment for at leasdt 6 months containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) plus 1 Non-nucleoside reverse-transcriptase inhibitor (NNRTI) or 1 protease inhibitor (PI) or 1 integrase inhibitor (ININ)
Viral load under 50 copies/mL in the last 6 months
Patients with CCR5 tropism based in V3 genotyping in proviral DNA using the G2P with a false positive rate of 10% interpretation method.
A change of treatment is needed due to toxicity / tolerability problems with the 3rd drug (PI, NNRTI or ININ), according to investigator criteria.
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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135

Exclusion Criteria

Pregnancy or breast-feeding.
Patient previously treated with maraviroc.
Patients with documented resistance to maraviroc or any other drug considered for the new ARV regimen.
Viral failure in the moment of inclusion.
Bad adherence history or anticipated (investigator criteria).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess whether the determination of viral tropism from proviral DNA in PBMCs is a suitable technique to guide treatment with CCR5 antagonists in patients with undetectable viral load who need antiretroviral treatment change for reasons of tolerability or adverse effects.;Secondary Objective: 1. To evaluate the virological efficacy of a treatment.<br><br>2. Evaluate other aspects related to the maintenance of virologic response.<br><br>3. Assess changes in the tropism of HIV-1 during the study.<br><br>4. Assess the tolerability and safety of a treatment.;Primary end point(s): Sustained virologic suppression at 48 weeks of treatment (viral load).;Timepoint(s) of evaluation of this end point: Week 48

Secondary Outcome Measures