Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to Antiretrovirals (ARVs) (EOLE)

Abbott

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01103596

P06-124

Details and patient eligibility

About

The purpose of this study is to evaluate, in patients in at least the second protease inhibitor (PI) line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes

Full description

The purpose of this study is to evaluate, in patients in at least the second PI line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes:

• Characterisation of the changes in the resistance genotype in protease and reverse transcriptase,
• Description of the nature and frequency of selected mutations under Kaletra®,
• Description of the predictive factors for mutations and of the impact they could have on other PIs used as maintenance treatment (analysis based on available algorithms).

EOLE is a prospective, multicentre observation study offered to French virology laboratories and involving clinical teams .

It is a transversal study with retrospective data collection for patients meeting the study criteria (virological failure under Kaletra® after at least first line PI treatment).

The study comprises two enrolment periods, separated by an interval of one year, over a period ranging from 2007 to 2011. During this period, virological failures under Kaletra® are identified. For each period, the virologists collect data only from the moment when virological failure under Kaletra® is identified.

The first wave of data collection is now completed and occurred from December 5, 2007 to July 03, 2009.

It is not planned to collect follow-up data in connection with alternative treatment with other antiretrovirals after failure under Kaletra®.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged under 18 years,
• Pre-treated by at least one protease inhibitor (PI) line,
• In therapeutic failure of the antiretroviral (ARV) maintenance treatment containing Kaletra®.

Therapeutic failure is defined by a viral load> 50 copies/ml after at least three months' treatment with an ARV combination containing Kaletra®, always provided that genotyping is possible .

Exclusion criteria

• Patients having received less than three months of Kaletra®,
• Patients for whom the genotype information before starting Kaletra® and at the time of the failure of Kaletra® was not available,
• Patients receiving another protease inhibitor (PI) concomitantly with Kaletra®.

Trial design

94 participants in 2 patient groups

HIV-infected patients, 1st wave

Description:

HIV-infected ARV-experienced patients treated by a combination including Kaletra

HIV-infected patients, 2nd wave

Description:

HIV-infected ARV-experienced patients treated by a combination including Kaletra