Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

August 6, 2014 updated by: Boehringer Ingelheim

Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

To obtain information on clinical practices for patients treated by Aptivus in real life

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France
        • Boehringer Ingelheim Investigational Site
      • Aix En Provence, France
        • Boehringer Ingelheim Investigational Site
      • Amiens, France
        • Boehringer Ingelheim Investigational Site
      • Argenteuil, France
        • Boehringer Ingelheim Investigational Site
      • Aulnay Sous Bois, France
        • Boehringer Ingelheim Investigational Site
      • Auxerre, France
        • Boehringer Ingelheim Investigational Site
      • Belfort, France
        • Boehringer Ingelheim Investigational Site
      • Besancon Cedex, France
        • Boehringer Ingelheim Investigational Site
      • Beziers, France
        • Boehringer Ingelheim Investigational Site
      • Bondy, France
        • Boehringer Ingelheim Investigational Site
      • Bordeaux, France
        • Boehringer Ingelheim Investigational Site
      • Briis Sous Forges, France
        • Boehringer Ingelheim Investigational Site
      • Cahors, France
        • Boehringer Ingelheim Investigational Site
      • Cannes, France
        • Boehringer Ingelheim Investigational Site
      • Chartres, France
        • Boehringer Ingelheim Investigational Site
      • Corbeil Essonnes, France
        • Boehringer Ingelheim Investigational Site
      • Creil, France
        • Boehringer Ingelheim Investigational Site
      • Creteil, France
        • Boehringer Ingelheim Investigational Site
      • DAX, France
        • Boehringer Ingelheim Investigational Site
      • Digne, France
        • Boehringer Ingelheim Investigational Site
      • Garches, France
        • Boehringer Ingelheim Investigational Site
      • La Roche Sur Yon, France
        • Boehringer Ingelheim Investigational Site
      • Le Mans, France
        • Boehringer Ingelheim Investigational Site
      • Le Petit Quevilly, France
        • Boehringer Ingelheim Investigational Site
      • Libourne, France
        • Boehringer Ingelheim Investigational Site
      • Lyon, France
        • Boehringer Ingelheim Investigational Site
      • Mantes La Jolie, France
        • Boehringer Ingelheim Investigational Site
      • Marseille, France
        • Boehringer Ingelheim Investigational Site
      • Metz, France
        • Boehringer Ingelheim Investigational Site
      • Mulhouse, France
        • Boehringer Ingelheim Investigational Site
      • Nancy, France
        • Boehringer Ingelheim Investigational Site
      • Nantes, France
        • Boehringer Ingelheim Investigational Site
      • Nevers, France
        • Boehringer Ingelheim Investigational Site
      • Nice, France
        • Boehringer Ingelheim Investigational Site
      • Orleans, France
        • Boehringer Ingelheim Investigational Site
      • Paris, France
        • Boehringer Ingelheim Investigational Site
      • Perigueux, France
        • Boehringer Ingelheim Investigational Site
      • Poitiers, France
        • Boehringer Ingelheim Investigational Site
      • Rouen, France
        • Boehringer Ingelheim Investigational Site
      • Saint Brieuc, France
        • Boehringer Ingelheim Investigational Site
      • Saint Nazaire, France
        • Boehringer Ingelheim Investigational Site
      • Saint-mande, France
        • Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1182.127.3301 Boehringer Ingelheim Investigational Site
      • Suresnes, France
        • Boehringer Ingelheim Investigational Site
      • Toulouse, France
        • Boehringer Ingelheim Investigational Site
      • Valenciennes, France
        • Boehringer Ingelheim Investigational Site
      • Villeneuve St G, France
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HIV-infected patients

Description

Inclusion Criteria:

  • HIV positive patients for whom Aptivus treatment is initiated by their physician
  • Aptivus SCP respect

Exclusion Criteria:

None if the inclusion criteria are respected: observational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3
Time Frame: 6 months after inclusion
The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3
6 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of Early Virological Response
Time Frame: 1 month after inclusion
Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10
1 month after inclusion
Viral Load Response at 1 Month
Time Frame: 1 month after inclusion
Please note that a reported value of "49 copies/mL" for the median or first quartile indicates that the observed statistic for the outcome measure is below the "limit of quantification" for viral load. The limit of quantification is 50 copies/mL.
1 month after inclusion
CD4 Count at 1 Month
Time Frame: 1 month after inclusion
1 month after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL
Time Frame: 3 months after inclusion
Number of patients with a viral load < 400 copies/mL after 3 months of treatment
3 months after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL
Time Frame: 3 months after inclusion
Number of patients with a viral load < 50 copies/mL after 3 months of treatment
3 months after inclusion
Viral Load Response at 3 Months
Time Frame: 3 months after inclusion
Please note that a reported value of "49 copies/mL" for the median or first quartile indicates that the observed statistic for the outcome measure is below the "limit of quantification" for viral load. The limit of quantification is 50 copies/mL.
3 months after inclusion
CD4 Count at 3 Months
Time Frame: 3 months after inclusion
3 months after inclusion
Patient Self Perception of the New Treatment
Time Frame: Day 0, month 3 and month 6
Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied"
Day 0, month 3 and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1182.127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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