HIV InfectionsNCT00615290

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

An observational study of HIV Infections, run by Boehringer Ingelheim at 48 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To obtain information on clinical practices for patients treated by Aptivus in real life Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: tipranavir
How many people: 42 participants
Where: 48 sitesFrance
Study dates: Jun 2007to May 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: HIV-infected patients

Who may be able to join

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

Who cannot join

None if the inclusion criteria are respected: observational study

Trial locations and contacts

48 sites in 1 country.

City, postcode or hospital

48 sites in 1 country

France48 sites

Boehringer Ingelheim Investigational Site
Agen
Boehringer Ingelheim Investigational Site
Aix-en-Provence
Boehringer Ingelheim Investigational Site
Amiens
Boehringer Ingelheim Investigational Site
Argenteuil
Boehringer Ingelheim Investigational Site
Aulnay-sous-Bois
Boehringer Ingelheim Investigational Site
Auxerre
Boehringer Ingelheim Investigational Site
Belfort
Boehringer Ingelheim Investigational Site
Besançon
Boehringer Ingelheim Investigational Site
Béziers
Boehringer Ingelheim Investigational Site
Bondy
Boehringer Ingelheim Investigational Site
Bordeaux
Boehringer Ingelheim Investigational Site
Briis-sous-Forges
Boehringer Ingelheim Investigational Site
Cahors
Boehringer Ingelheim Investigational Site
Cannes
Boehringer Ingelheim Investigational Site
Chartres
Boehringer Ingelheim Investigational Site
Corbeil-Essonnes
Boehringer Ingelheim Investigational Site
Creil
Boehringer Ingelheim Investigational Site
Créteil
Boehringer Ingelheim Investigational Site
Dax
Boehringer Ingelheim Investigational Site
Digne-les-Bains
Boehringer Ingelheim Investigational Site
Garches
Boehringer Ingelheim Investigational Site
La Roche-sur-Yon
Boehringer Ingelheim Investigational Site
Le Mans
Boehringer Ingelheim Investigational Site
Le Petit-Quevilly
Boehringer Ingelheim Investigational Site
Libourne
Boehringer Ingelheim Investigational Site
Lyon
Boehringer Ingelheim Investigational Site
Mantes-la-Jolie
Boehringer Ingelheim Investigational Site
Marseille
Boehringer Ingelheim Investigational Site
Metz
Boehringer Ingelheim Investigational Site
Mulhouse
Boehringer Ingelheim Investigational Site
Nancy
Boehringer Ingelheim Investigational Site
Nantes
Boehringer Ingelheim Investigational Site
Nevers
Boehringer Ingelheim Investigational Site
Nice
Boehringer Ingelheim Investigational Site
Orléans
Boehringer Ingelheim Investigational Site
Paris
Boehringer Ingelheim Investigational Site
Périgueux
Boehringer Ingelheim Investigational Site
Poitiers
Boehringer Ingelheim Investigational Site
Rouen
Boehringer Ingelheim Investigational Site
Saint-Brieuc
Boehringer Ingelheim Investigational Site
Saint-Mandé
Boehringer Ingelheim Investigational Site
Saint-Nazaire
1182.127.3301 Boehringer Ingelheim Investigational Site
Strasbourg
Boehringer Ingelheim Investigational Site
Strasbourg
Boehringer Ingelheim Investigational Site
Suresnes
Boehringer Ingelheim Investigational Site
Toulouse
Boehringer Ingelheim Investigational Site
Valenciennes
Boehringer Ingelheim Investigational Site
Villeneuve Saint G

Other trials in France

About this study

Official title: 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

Conditions: HIV Infections
Being tested: tipranavir
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tipranavirDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3
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
Measured: 6 months after inclusion

Secondary outcomes (8)

Evaluation of Early Virological Response
Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10
Measured: 1 month after inclusion
Viral Load Response at 1 Month
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.
Measured: 1 month after inclusion
CD4 Count at 1 Month
Measured: 1 month after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL
Number of patients with a viral load < 400 copies/mL after 3 months of treatment
Measured: 3 months after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL
Number of patients with a viral load < 50 copies/mL after 3 months of treatment
Measured: 3 months after inclusion
Viral Load Response at 3 Months
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.
Measured: 3 months after inclusion
CD4 Count at 3 Months
Measured: 3 months after inclusion
Patient Self Perception of the New Treatment
Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied"
Measured: Day 0, month 3 and month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007May 2009

First posted14 Feb 2008 (estimated)
Study startJun 2007
Primary completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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
Observational model: Case only
Time perspective: Prospective
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615290
Sponsor's protocol ID: 1182.127
Status last verified: Aug 2014
First submitted: 31 Jan 2008
Last updated: 8 Aug 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy
ClinicalTrials.gov ID: NCT00615290
Acronym / sponsor ID: 1182.127
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: May 2009 (actual)
First posted: 14 Feb 2008 (estimated)
Results: Posted 23 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: HIV-infected patients

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None if the inclusion criteria are respected: observational study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tipranavir	Drug	–

Primary outcome

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

8 secondary outcomes

Evaluation of Early Virological Response
Time frame: 1 month after inclusion
Viral Load Response at 1 Month
Time frame: 1 month after inclusion
CD4 Count at 1 Month
Time frame: 1 month after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL
Time frame: 3 months after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL
Time frame: 3 months after inclusion
Viral Load Response at 3 Months
Time frame: 3 months after inclusion
CD4 Count at 3 Months
Time frame: 3 months after inclusion
Patient Self Perception of the New Treatment
Time frame: Day 0, month 3 and month 6

Results and safety

Results posted to the registry on 23 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aptivus	42	34

Primary outcome: 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. Number. Unit: participants

Measure	Aptivus n = 42
Value	8

Population analysed: All enrolled patients with data at 6 months

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aptivus	3 of 42 (7.1%)	0 of 42 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
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HIV, Substance Use Disorder

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

48 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 Infections, run by Boehringer Ingelheim at 48 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 2 inclusion and 1 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 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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?

Yes. Results are posted in the registry (first posted 23 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00615290.

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 8 Aug 2014.