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Maraviroc and cardiovascular risk in HIV+ patients.

Evalutation of maraviroc therapy in PI-treated HIV+ patients at intermediate-low risk for cardiovascular diseases: a phase IV, randomized, open study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-002134-31-IT
Enrollment
Unknown
Registered
2014-10-08
Start date
2015-07-22
Completion date
Unknown
Last updated
2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection.

Interventions

Trade Name: Celsentri Product Name: NA Product Code: NA Pharmaceutical Form: Film-coated tablet Trade Name: Celsentri Product Name: NA Product Code: NA Pharmaceutical Form: Film-coated tablet

Sponsors

Ospedale L. Sacco - Azienda Ospedaliera-Polo Universitario
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: HIV+ Stable 2NRTI+PI-based therapy for at least one year VL =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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: Cholesterol parameters Microbial traslocation Linphocytes and monocytes immuno-activation parameters Immunological parameters associated with atherosclerotic process 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

MeasureTime frame
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: Cholesterol parameters Microbial traslocation Linphocytes and monocytes immuno-activation parameters Immunological parameters associated with atherosclerotic process % of HIV-specific CD4 positive cells. reversibile effect of maraviroc;Timepoint(s) of evaluation of this end point: 1 year.—

Countries

Italy

Contacts

Public ContactI Divisione di Malattie Infettive

Ospedale L. Sacco - Azienda Ospedaliera-Polo Universitario

piconi.stefania@hsacco.it00390239043480

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026