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

HIV Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01705873
• Other study ID #: ANV-10-0165
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2012
• Last updated: October 11, 2012
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2012
• Source: Helios Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• HIV
• Hypercholesterolemia

Locations

Country	Name	City	State
Argentina	Helios Salud	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Helios Salud	Abbott

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes