HIV InfectionEOLENCT01103596
Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to Antiretrovirals (ARVs)
An observational study of HIV Infection, run by Abbott at 19 sites in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 94 participants
- Where
- 19 sitesFrance
- Study dates
- Mar 2008to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Virology laboratories
Who may be able to join
- 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 .
Who cannot join
- 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 locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Site Reference ID/Investigator# 27801
Angers, 49100
Site Reference ID/Investigator# 27799
Bordeaux, 33075
Site Reference ID/Investigator# 27790
Grenoble, 38043
Site Reference ID/Investigator# 27796
Lille, 59037
Site Reference ID/Investigator# 27786
Montpellier, 34295
Site Reference ID/Investigator# 27800
Nantes, 44093
Site Reference ID/Investigator# 27798
Nice, 06202
Site Reference ID/Investigator# 27792
Nîmes, 30029
Site Reference ID/Investigator# 5595
Paris, 75013
Site Reference ID/Investigator# 27787
Paris, 75475
Site Reference ID/Investigator# 27797
Paris, 75571
Site Reference ID/Investigator# 27783
Paris, 75877
Site Reference ID/Investigator# 27802
Paris, 75908
Site Reference ID/Investigator# 27785
Paris, 75970
Site Reference ID/Investigator# 27791
Rennes, 35700
Site Reference ID/Investigator# 27788
Rouen, 76000
Site Reference ID/Investigator# 27789
Toulon, 83056
Site Reference ID/Investigator# 27794
Toulouse, 31000
Site Reference ID/Investigator# 27784
Villejuif, 94804
About this study
Official title: Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to ARVs - EOLE
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
Read the detailed 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®.
- Conditions
- HIV Infection
- Keywords
- Evaluation of the impact of Kaletra on antiretroviral resistance
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected patients, 1st wave | HIV-infected ARV-experienced patients treated by a combination including Kaletra | |
| HIV-infected patients, 2nd wave | HIV-infected ARV-experienced patients treated by a combination including Kaletra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype for resistance determination
Measured: Over the duration of the enrollment for each wave, over a total period of 18 months
Description of the predictive factors for mutations and of the impact they could have on other protease inhibitors (PIs) used as maintenance treatment (analysis based on available algorithms).
Measured: Over the duration of the enrollment for each wave, over a total period of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startMar 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Readitwell, Lincoln Medical and Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Isabelle Cohen Codar, PharmD, Study director, Abbott France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103596
- Sponsor's protocol ID
- P06-124
- Acronym
- EOLE
- Status last verified
- Dec 2011
- First submitted
- 24 Feb 2010
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to ARVs - EOLE
- ClinicalTrials.gov ID
- NCT01103596
- Acronym / sponsor ID
- EOLE / P06-124
- Conditions
- HIV Infection
- Keywords
- Evaluation of the impact of Kaletra on antiretroviral resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Readitwell, Lincoln Medical and Mental Health Center
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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®.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected patients, 1st wave | – | –HIV-infected ARV-experienced patients treated by a combination including Kaletra |
| HIV-infected patients, 2nd wave | – | –HIV-infected ARV-experienced patients treated by a combination including Kaletra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Virology laboratories
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (3 listed)
- 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®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genotype for resistance determination
Time frame: Over the duration of the enrollment for each wave, over a total period of 18 months
Description of the predictive factors for mutations and of the impact they could have on other protease inhibitors (PIs) used as maintenance treatment (analysis based on available algorithms).
Time frame: Over the duration of the enrollment for each wave, over a total period of 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Cohen Codar, PharmD study director
Abbott France
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Abbott at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype for resistance determination (time frame: Over the duration of the enrollment for each wave, over a total period of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2011.