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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Helios Salud.
Recruitment status was  Recruiting
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

October 5, 2012
October 11, 2012
September 2012
March 2013   (final data collection date for primary outcome measure)
  • 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 .
Same as current
Complete list of historical versions of study NCT01705873 on ClinicalTrials.gov Archive Site
  • 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 .
Same as current
  • 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 .
Same as current
 
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 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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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

  • HIV
  • Hypercholesterolemia
  • Dyslipidemia
Not Provided
  • LPV/r
    LPV/r based HAART
  • Efavirenz
    EFV first line based HAART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
August 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Argentina
 
NCT01705873
ANV-10-0165
No
Isabel Cassetti, Helios Salud
Helios Salud
Abbott
Principal Investigator: Lidia I Cassetti, MD Helios Salud
Study Chair: Diego M Cecchini, PhD Helios Salud
Helios Salud
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP