NCT01705873

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

6 months

First QC Date

October 5, 2012

Last Update Submit

October 11, 2012

Conditions

HIVHypercholesterolemiaDyslipidemia

Keywords

HIVcardiovascularriskmortality

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (3)

  • All cause mortality

    Per year

  • All cause mortality

    Per year

  • All cause mortality

    Per year

Other Outcomes (3)

  • Evolution of lipid profile

    Per year

  • Evolution of lipid profile

    Per year

  • Evolution of lipid profile

    Per year

Study Arms (2)

LPV/r

LPV/r based HAART

Efavirenz

EFV first line based HAART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • HIV positive patients (confirmation with ELISA + W. blot required).
  • Age ≥ 18 years.
  • Naïve or experienced with antiretroviral drugs.
  • LPV/r or EFV as first line regimen.
  • In patients with a LPV/r second line HAART regimen, prior exposure to any NNRTI regimen is acceptable.
  • Time of exposure to LPV/r or EFV of at least 48 weeks.

You may not qualify if:

  • Age \< 18 yrs.
  • 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 )
  • Patients that had received LPV/r only during they pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Salud

Buenos Aires, 1141, Argentina

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25394054DERIVED

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemias

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lidia I Cassetti, MD

    Helios Salud

    PRINCIPAL INVESTIGATOR

  • Diego M Cecchini, PhD

    Helios Salud

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 12, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

August 1, 2013

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

AR(1)