NCT00843661

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Mar 2009

Typical duration for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 2, 2011

Status Verified

July 1, 2011

Enrollment Period

2.8 years

First QC Date

February 12, 2009

Last Update Submit

August 1, 2011

Conditions

HIVHyperlipidemiaHIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (1)

  • per cent changes of LDL cholesterol, comparison between the 2 treatment regimens

    After 6 month treatment

Study Arms (2)

Ezetimibe and fenofibrate

EXPERIMENTAL
Drug: ezetimibeDrug: fenofibrate

Pravastatin

ACTIVE COMPARATOR
Drug: pravastatin

Interventions

ezetimibeDRUG

10 mg ezetimibe/day

Ezetimibe and fenofibrate
fenofibrateDRUG

200 mg fenofibrate/day

Ezetimibe and fenofibrate
pravastatinDRUG

40 mg pravastatin/day

Pravastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale di Circolo and Fondazione Macchi

Varese, Varese, 21100, Italy

RECRUITING

MeSH Terms

Conditions

HyperlipidemiasHIV Infections

Interventions

EzetimibeFenofibratePravastatin

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetonesNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Central Study Contacts

Anna Maria Grandi, MD

CONTACT

+390332278403amgrandi@libero.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

July 1, 2012

Last Updated

August 2, 2011

Record last verified: 2011-07

Locations

IT(1)