Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients Receiving Protease Inhibitors: a Randomized, Prospective, Controlled Pilot Study.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00843661

Enrollment

Registered

2009-02-13

Start date

2009-03-31

Completion date

2012-07-31

Last updated

2011-08-02

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

Conditions

HIV, HIV Infections, Hyperlipidemia

Keywords

Treatment Experienced

Brief summary

* The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors. * Single-centre, open, randomized, controlled, prospective pilot study. * 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.

Interventions

DRUGezetimibe

10 mg ezetimibe/day

DRUGfenofibrate

200 mg fenofibrate/day

DRUGpravastatin

40 mg pravastatin/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients older than 18 years * documented positive HIV antibodies test * on stable therapy with PIs for at least 12 months * LDL-cholesterol \>130 mg/dl or triglycerides 200 - 500 mg/dl with non-HDL cholesterol \>160 mg/dl * unresponsive to dietary measures and regular physical exercise of at

Exclusion criteria

* history of dyslipidemia before antiretroviral therapy * cardiovascular and cerebrovascular diseases * Cushing's syndrome * concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers * hypothyroidism * Type 1 diabetes mellitus * renal failure

Design outcomes

Primary

Measure	Time frame
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens	After 6 month treatment

Countries

Italy

Contacts

Primary ContactAnna Maria Grandi, MD

amgrandi@libero.it+390332278403

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026