Maraviroc and cardiovascular risk in HIV+ patients.
- Conditions
- HIV-1 infection.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-002134-31-IT
- Lead Sponsor
- Ospedale L. Sacco - Azienda Ospedaliera-Polo Universitario
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
HIV+
Stable 2NRTI+PI-based therapy for at least one year
VL < 37copies/ml for at least 6 months
X5 viral tropism
Framingham score 5%
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
Creatine Clereance <50ml/min
GFR < 60 ml/ml
Statine therapy
tipranavir/ritonavir therapy
Immunomodulants treatments in the previous year before the recruitment.
Cardiovascular events in the last year
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the effects of Maraviroc implementation on intima media thickness in aviremic PI-treated HIV-positive patients at intermediate-low risk for cardiovascular diseases (FRS 5%).;Secondary Objective: Evaluate the effects of MVC therapy addiction on:<br>Cholesterol parameters<br>Microbial traslocation<br>Linphocytes and monocytes immuno-activation parameters<br>Immunological parameters associated with atherosclerotic process<br>reversibile effect of maraviroc;Primary end point(s): Difference of variation of 0.25 mm in comparison to the basal value of the intimate-media carotidea thickness(IMT) in the 80% of the patients after six months the introduction of Maraviroc;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): descriptive analysis of the effects of MVC therapy addiction in HIV PIs-treated patients at intermediate risk of cardiovascular diseases on:<br>Cholesterol parameters<br>Microbial traslocation<br>Linphocytes and monocytes immuno-activation parameters<br>Immunological parameters associated with atherosclerotic process<br>% of HIV-specific CD4 positive cells.<br>reversibile effect of maraviroc;Timepoint(s) of evaluation of this end point: 1 year.