A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

An observational study of HIV Infections, run by Boehringer Ingelheim at 20 sites in Romania.

Completed

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

Trial summary

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor. 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 and ritonavir
How many people: 42 participants
Where: 20 sitesRomania
Study dates: Sep 2009to Jul 2011
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: patients

Who may be able to join

HIV-1 infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than one protease inhibitor and no other therapeutic options.
The inclusion criteria follow the same criteria which are describe in the newest SPC

Who cannot join

The exclusion criteria follow the same criteria which are describe in the newest SPC

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Romania20 sites

Boehringer Ingelheim Investigational site 9
Arad
Boehringer Ingelheim Investigational site 13
Bacau
Boehringer Ingelheim Investigational site 17
Brasov
Boehringer Ingelheim Investigational site 18
Brasov
Boehringer Ingelheim Investigational site 19
Brasov
Boehringer Ingelheim Investigational site 1
Bucharest
Boehringer Ingelheim Investigational site 2
Bucharest
Boehringer Ingelheim Investigational site 3
Bucharest
Boehringer Ingelheim Investigational site 4
Bucharest
Boehringer Ingelheim Investigational site 5
Bucharest
Boehringer Ingelheim Investigational site 6
Bucharest
Boehringer Ingelheim Investigational site 7
Bucharest
Boehringer Ingelheim Investigational site 8
Bucharest
Boehringer Ingelheim Investigational site 16
Constanța
Boehringer Ingelheim Investigational site 11
Craiova
Boehringer Ingelheim Investigational site 12
Craiova
Boehringer Ingelheim Investigational site 15
Galati
Boehringer Ingelheim Investigational site 20
Tg.Mures
Boehringer Ingelheim Investigational site 10
Timișoara
Boehringer Ingelheim Investigational site 14
Vaslui

Other trials in Romania

About this study

Official title: A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Tipranavir (Aptivus®) Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

Conditions: HIV Infections
Being tested: Tipranavir, ritonavir
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
ritonavirDrug
low-dose

Study groups in NCT00976950
Study group	Role	What they receive
Patients with HIV-1 infection		Not described Receives: Drug: Tipranavir; Drug: ritonavir

What is being measured

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

Number of Patients Reporting Adverse Events (AE)
Any type of adverse events
Measured: 48 weeks

Secondary outcomes (2)

Virologic Response
Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.
Measured: 48 weeks
Change in CD4+ Cell Count From Baseline at Week 48
Measured: 48 weeks

Timeline

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

Sep 2009Jul 2011

First posted15 Sep 2009 (estimated)
Study startSep 2009
Primary completionJul 2011
Study completionJul 2011

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: Cohort
Time perspective: Prospective
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00976950
Sponsor's protocol ID: 1182.147
Status last verified: Feb 2014
First submitted: 14 Sep 2009
Last updated: 20 Mar 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 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Tipranavir (Aptivus®) Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.
ClinicalTrials.gov ID: NCT00976950
Acronym / sponsor ID: 1182.147
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 15 Sep 2009 (estimated)
Results: Posted 16 Aug 2012

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with HIV-1 infection	–	Drug: Tipranavir, Drug: ritonavir

Who may qualify

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

Key inclusion criteria (2 listed)

HIV-1 infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than one protease inhibitor and no other therapeutic options.
The inclusion criteria follow the same criteria which are describe in the newest SPC

Key exclusion criteria (1 listed)

The exclusion criteria follow the same criteria which are describe in the newest SPC

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	Patients with HIV-1 infection
ritonavirlow-dose	Drug	Patients with HIV-1 infection

Primary outcome

Number of Patients Reporting Adverse Events (AE)
Time frame: 48 weeks
Any type of adverse events

2 secondary outcomes

Virologic Response
Time frame: 48 weeks
Change in CD4+ Cell Count From Baseline at Week 48
Time frame: 48 weeks

Results and safety

Results posted to the registry on 16 Aug 2012, 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 and Ritonavir	42	36

Primary outcome: Number of Patients Reporting Adverse Events (AE)

Time frame: 48 weeks. Number. Unit: Participants

Measure	Aptivus and Ritonavir n = 42
Patients with any adverse events	6
Patients with any serious adverse events	1
Patients with AE leading to discontinuation	4
Patients with hepatic adverse events	1
Patients with dyslipidemia	2

Population analysed: Treated set (TS), defined as patients treated with Aptivus

2 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 and Ritonavir	1 of 42 (2.4%)	0 of 42 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

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

20 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 20 sites in Romania.

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 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Romania. 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 16 Aug 2012). 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 Reporting Adverse Events (AE) (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 NCT00976950.

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 20 Mar 2014.