Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen

Retrospective Analysis on the Risk of Cardiovascular (CV) Events in HIV- Infected Subjects From Latin America Treated With a Lopinavir/Ritonavir (LPV/r) Based HAART Regimen vs. an Efavirenz (EFV) Based HAART Regimen

The objective of this study is to evaluate 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, considering LPV/r vs EFV based HAART. The null hyphotesis is that there is an increased Framingham score in patients treated with LPV/r as second line treatment and in patients treated with LPV/r or EFV regimen as first line treatments.

Study Overview

• Status: Unknown
• Conditions: Dyslipidemia; HIV; Hypercholesterolemia

Detailed Description

Study design and duration: Retrospective comparative study. Estimated time of enrollment: 12 months.

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1141
    • Recruiting
    • Helios Salud
    • Contact: Diego M Cecchini, PhD; Phone Number: 116 54 11 4896 1868; Email: dcecchini@heliossalud.com.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

HIV-infected patients with first line HAART with EFV or LPV/r or second line HAART with LPV/r

Description

Inclusion criteria

1. HIV positive patients (confirmation with ELISA + W. blot required).
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:

1. Age < 18 yrs.
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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LPV/r; LPV/r based HAART
Efavirenz; EFV first line based HAART

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk for CV events	Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in the whole population under study.Participants will be followed for an average of 24 months .	Per year
Risk for CV events	Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in male subpopulation.Participants will be followed for an average of 24 months .	Per year
Risk for CV events	Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in female subpopulation. Participants will be followed for an average of 24 months .	Per year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	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 in the whole population under study. Participants will be followed for an average of 24 months .	Per year
All cause mortality	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 in male subpopulation.Participants will be followed for an average of 24 months .	Per year
All cause mortality	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 in female subpopulation. Participants will be followed for an average of 24 months .	Per year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of lipid profile	Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in the whole population under study. Participants will be followed for an average of 24 months .	Per year
Evolution of lipid profile	Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in male subpopulation. Participants will be followed for an average of 24 months .	Per year
Evolution of lipid profile	Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in female subpopulation. Participants will be followed for an average of 24 months .	Per year

Collaborators and Investigators

• Sponsor: Helios Salud
• Collaborators: Abbott
• Investigators: Principal Investigator: Lidia I Cassetti, MD, Helios Salud; Study Chair: Diego M Cecchini, PhD, Helios Salud

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: October 11, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Estimate): October 12, 2012
• Last Update Submitted That Met QC Criteria: October 11, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: HIV; mortality; risk; cardiovascular
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: ANV-10-0165