Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Population

An observational study of HIV Infections, run by Boehringer Ingelheim at 21 sites in Italy.

Completed

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

Trial summary

Data collection for better patient characterization in a highly treatment experienced population. Studying the clinical practice for the treatment of HIV multiexperienced patients in the 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?: TPV
How many people: 428 participants
Where: 21 sitesItaly
Study dates: Jun 2007to Oct 2008
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: HIV patients

Who may be able to join

Patients double PIs failure

Who cannot join

Not Applicable

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Italy21 sites

Boehringer Ingelheim Investigational Site
Ancona
Boehringer Ingelheim Investigational Site
Bari
Boehringer Ingelheim Investigational Site
Benevento
Boehringer Ingelheim Investigational Site
Bisceglie
Boehringer Ingelheim Investigational Site
Bologna
Boehringer Ingelheim Investigational Site
Brescia
Boehringer Ingelheim Investigational Site
Busto
Boehringer Ingelheim Investigational Site
Caserta
Boehringer Ingelheim Investigational Site
Catania
Boehringer Ingelheim Investigational Site
Cremona
Boehringer Ingelheim Investigational Site
Florence
Boehringer Ingelheim Investigational Site
Genova
Boehringer Ingelheim Investigational Site
Legnano
Boehringer Ingelheim Investigational Site
Milan
Boehringer Ingelheim Investigational Site
Naples
Boehringer Ingelheim Investigational Site
Padova
Boehringer Ingelheim Investigational Site
Palermo
Boehringer Ingelheim Investigational Site
Pavia
Boehringer Ingelheim Investigational Site
Roma
Boehringer Ingelheim Investigational Site
Sassari
Boehringer Ingelheim Investigational Site
Torino

Other trials in Italy

About this study

Official title: Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Patient Population

Data collection for better patient characterization in a highly treatment experienced population. Studying the clinical practice for the treatment of HIV multiexperienced patients in the real life.

The research will be divided into two phases:

The first phase intends to define and understand the clinical practice using a questionnaire about general topics: definitions of multiexperienced patients and VL failure, therapeutic strategies and behaviour in particular cases.
The second part of the research will collect the clinical data of double PIs failure patients.

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

What participants receive

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

TPVDrug

What is being measured

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

To study in the clinical practice the choice of a specific salvage regimen for multiexperienced patients.
Measured: 48 weeks

Secondary outcomes (1)

Reason of each VL failure or switching
Measured: 48 weeks

Timeline

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

Jun 2007Oct 2008

First posted13 Feb 2008 (estimated)
Study startJun 2007
Primary completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Cohort
Time perspective: Prospective
Enrolment: 428 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00614302
Sponsor's protocol ID: 1182.130
Status last verified: Oct 2009
First submitted: 31 Jan 2008
Last updated: 2 Oct 2009
Results posted: No

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

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
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Patient Population
ClinicalTrials.gov ID: NCT00614302
Acronym / sponsor ID: 1182.130
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 428 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Oct 2008 (actual)
First posted: 13 Feb 2008 (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.

Data collection for better patient characterization in a highly treatment experienced population. Studying the clinical practice for the treatment of HIV multiexperienced patients in the real life.

The research will be divided into two phases:

The first phase intends to define and understand the clinical practice using a questionnaire about general topics: definitions of multiexperienced patients and VL failure, therapeutic strategies and behaviour in particular cases.
The second part of the research will collect the clinical data of double PIs failure patients.

Study design

Observational model: Cohort
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 patients

Key inclusion criteria (1 listed)

Patients double PIs failure

Key exclusion criteria (1 listed)

Not Applicable

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
TPV	Drug	–

Primary outcome

To study in the clinical practice the choice of a specific salvage regimen for multiexperienced patients.
Time frame: 48 weeks

1 secondary outcome

Reason of each VL failure or switching
Time frame: 48 weeks

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 2 Oct 2009.

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
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
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

21 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 21 sites in Italy.

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 1 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 2 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Italy. 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?

To study in the clinical practice the choice of a specific salvage regimen for multiexperienced patients. (time frame: 48 weeks). 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 NCT00614302.

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 2 Oct 2009.