Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen
NCT ID: NCT01705873
Last Updated: 2012-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2012-09-30
2013-08-31
Brief Summary
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Detailed Description
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Procedure: Retrospective review of clinical charts: LPV/r (n = 100) and EFV (a randomly selected representative sample of patients under EFV treatment: 200 patients approximately.). Each patient can only be included in one arm of the study (cannot switch EFV to LPV/r or from LPV/r to EFV)
Subject population
LPV/r (n = 100) and EFV (a randomly selected representative sample of patients under EFV treatment: 200 patients approximately.). Each patient can only be included in one arm of the study (cannot switch EFV to LPV/r or from LPV/r to EFV)
Study Objectives:
Primary Objectives
1)Changes in Framingham score (from low to moderate, from moderate to high) based on changes in lipid profile and other parameters from baseline to 48 weeks of HAART in naïve patients or patients in second line of treatment Secondary Objectives
1. Risk assessment hazard of CV events in HIV- infected subjects treated with a LPV/r as second line and EFV and LPV/r first line based HAART regimen in the whole population under study and in the female and male subpopulations.
2. Assessment for 10- year risk of developing hard cardiovascular events (myocardial infarction and coronary death) in HIV- infected subjects treated with a LPV/r ( 1° o 2° line) and EFV first line based HAART regimen
3. Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r as second line and EFV and LPV/r first line based HAART regimen
4. Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement: baseline vs. 48 weeks after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r and EFV first line based HAART regimen
5. Assesment of CD4 T-cell count and viral load at baseline and at 48 weeks in each regimen.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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LPV/r
LPV/r based HAART
No interventions assigned to this group
Efavirenz
EFV first line based HAART
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Naïve or experienced with antiretroviral drugs.
4. LPV/r or EFV as first line regimen.
5. In patients with a LPV/r second line HAART regimen, prior exposure to any NNRTI regimen is acceptable.
6. Time of exposure to LPV/r or EFV of at least 48 weeks.
Exclusion Criteria
2. Already LPV/r treatment at admission in our institution (that prevents assessment of baseline lipid profile and CV risk when patient receives the "first dose" of either LPV/r )
3. Patients that had received LPV/r only during they pregnancy.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Helios Salud
OTHER
Responsible Party
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Isabel Cassetti
MD
Principal Investigators
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Lidia I Cassetti, MD
Role: PRINCIPAL_INVESTIGATOR
Helios Salud
Diego M Cecchini, PhD
Role: STUDY_CHAIR
Helios Salud
Locations
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Helios Salud
Buenos Aires, , Argentina
Countries
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Facility Contacts
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Diego M Cecchini, PhD
Role: primary
References
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Cecchini D, Mattioli MI, Cassetti J, Chan D, Cassetti I. Evolution of Framingham cardiovascular risk score in HIV-infected patients initiating EFV- and LPV/r-based HAART in a Latin American cohort. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19547. doi: 10.7448/IAS.17.4.19547. eCollection 2014.
Other Identifiers
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ANV-10-0165
Identifier Type: -
Identifier Source: org_study_id