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

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ClinicalTrials.gov Identifier: NCT01705873
Recruitment Status : Unknown
Verified October 2012 by Isabel Cassetti, Helios Salud.
Recruitment status was:  Recruiting
First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Isabel Cassetti, Helios Salud

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
HIV Hypercholesterolemia Dyslipidemia

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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
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
Study Start Date : September 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. Risk for CV events [ Time Frame: Per year ]
    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 .

  2. Risk for CV events [ Time Frame: Per year ]
    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 .

  3. Risk for CV events [ Time Frame: Per year ]
    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 :
  1. All cause mortality [ Time Frame: Per year ]
    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 .

  2. All cause mortality [ Time Frame: Per year ]
    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 .

  3. All cause mortality [ Time Frame: Per year ]
    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:
  1. Evolution of lipid profile [ Time Frame: Per year ]
    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 .

  2. Evolution of lipid profile [ Time Frame: Per year ]
    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 .

  3. Evolution of lipid profile [ Time Frame: Per year ]
    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 .


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Isabel Cassetti, MD, Helios Salud
ClinicalTrials.gov Identifier: NCT01705873     History of Changes
Other Study ID Numbers: ANV-10-0165
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012

Keywords provided by Isabel Cassetti, Helios Salud:
HIV
cardiovascular
risk
mortality

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers