Clinical trial NCT01705873: Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Hypercholesterolemia
Dyslipidemia
Keywords: HIV
cardiovascular
risk
mortality
Lead sponsor: Helios Salud
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2012-10-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Risk for CV events
timeFrame: Per year
measure: Risk for CV events
timeFrame: Per year
measure: Risk for CV events
timeFrame: Per year
Secondary outcomes:
measure: All cause mortality
timeFrame: Per year
measure: All cause mortality
timeFrame: Per year
measure: All cause mortality
timeFrame: Per year
Other outcomes:
measure: Evolution of lipid profile
timeFrame: Per year
measure: Evolution of lipid profile
timeFrame: Per year
measure: Evolution of lipid profile
timeFrame: Per year
Locations:
city: Buenos Aires
country: Argentina
facility: Helios Salud
Study officials:
affiliation: Helios Salud
name: Lidia I Cassetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helios Salud
name: Diego M Cecchini, PhD
role: STUDY_CHAIR
References:
citation: 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.