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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Helios Salud
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Isabel Cassetti, Helios Salud
ClinicalTrials.gov Identifier:
NCT01705873
First received: October 5, 2012
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition
HIV
Hypercholesterolemia
Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Helios Salud:

Primary Outcome Measures:
  • Risk for CV events [ Time Frame: Per year ] [ Designated as safety issue: Yes ]
    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 .

  • Risk for CV events [ Time Frame: Per year ] [ Designated as safety issue: Yes ]
    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 .

  • Risk for CV events [ Time Frame: Per year ] [ Designated as safety issue: Yes ]
    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 .


Secondary Outcome Measures:
  • All cause mortality [ Time Frame: Per year ] [ Designated as safety issue: Yes ]
    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 .

  • All cause mortality [ Time Frame: Per year ] [ Designated as safety issue: Yes ]
    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 .

  • All cause mortality [ Time Frame: Per year ] [ Designated as safety issue: Yes ]
    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 .


Other Outcome Measures:
  • Evolution of lipid profile [ Time Frame: Per year ] [ Designated as safety issue: No ]
    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 .

  • Evolution of lipid profile [ Time Frame: Per year ] [ Designated as safety issue: No ]
    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 .

  • Evolution of lipid profile [ Time Frame: Per year ] [ Designated as safety issue: No ]
    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 .


Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
LPV/r
LPV/r based HAART
Efavirenz
EFV first line based HAART

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705873

Locations
Argentina
Helios Salud Recruiting
Buenos Aires, Argentina, 1141
Contact: Diego M Cecchini, PhD    54 11 4896 1868 ext 116    dcecchini@heliossalud.com.ar   
Sponsors and Collaborators
Helios Salud
Abbott
Investigators
Principal Investigator: Lidia I Cassetti, MD Helios Salud
Study Chair: Diego M Cecchini, PhD Helios Salud
  More Information

No publications provided

Responsible Party: Isabel Cassetti, MD, Helios Salud
ClinicalTrials.gov Identifier: NCT01705873     History of Changes
Other Study ID Numbers: ANV-10-0165
Study First Received: October 5, 2012
Last Updated: October 11, 2012
Health Authority: Argentina: Human Research Bioethics Committee

Keywords provided by Helios Salud:
HIV
cardiovascular
risk
mortality

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014