HIV InfectionsNCT00531206
Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
An observational study of HIV Infections, run by Boehringer Ingelheim at 27 sites in Germany.
Trial summary
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection. 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
- 65 participants
- Where
- 27 sitesGermany
- Study dates
- Aug 2006to Jan 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: Patients
Who may be able to join
- Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
Who cannot join
- Age < 18 years
- pregnant female patients
- Hypersensitivity to the active substance or to any of the excipients.
- Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
- Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
- Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.
- Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Germany27 sites
Boehringer Ingelheim Investigational Site
Aachen
Boehringer Ingelheim Investigational Site
Berlin
Boehringer Ingelheim Investigational Site
Bremen
Boehringer Ingelheim Investigational Site
Cologne
Boehringer Ingelheim Investigational Site
Dortmund
Boehringer Ingelheim Investigational Site
Düsseldorf
Boehringer Ingelheim Investigational Site
Erlangen
Boehringer Ingelheim Investigational Site
Frankfurt am Main
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site
Giessen
Boehringer Ingelheim Investigational Site
Halle
Boehringer Ingelheim Investigational Site
Hamburg
Boehringer Ingelheim Investigational Site
Hanover
Boehringer Ingelheim Investigational Site
Homburg/Saar
Boehringer Ingelheim Investigational Site
Karlsruhe
Boehringer Ingelheim Investigational Site
Krefeld
Boehringer Ingelheim Investigational Site
Leipzig
Boehringer Ingelheim Investigational Site
Magdeburg
Boehringer Ingelheim Investigational Site
Mainz
Boehringer Ingelheim Investigational Site
München
Boehringer Ingelheim Investigational Site
Münster
Boehringer Ingelheim Investigational Site
Nuremberg
Boehringer Ingelheim Investigational Site
Oldenburg
Boehringer Ingelheim Investigational Site
Osnabrück
Boehringer Ingelheim Investigational Site
Saarbrücken
Boehringer Ingelheim Investigational Site
Stuttgart
Boehringer Ingelheim Investigational Site
Wuppertal
About this study
Official title: Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.
- 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 group | Role | What they receive |
|---|---|---|
| All participants | Not described Receives: Drug: Tipranavir; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Measured: 52 weeks
Secondary outcomes (20)
Change in Viral Load
Log10 change from baseline in viral load over time
Measured: Baseline and 52 weeks
CD4+ Cell Count
Change from baseline in CD4+ count over time
Measured: Baseline and 52 weeks
Subjective Well-being
Investigator's opinion of patient's general condition (quality of life)
Measured: 52 weeks
Serious Adverse Events
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Measured: 52 weeks
Deaths
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Measured: 52 weeks
Discontinuations Due to an Adverse Event
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Measured: 52 weeks
Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Measured: 52 weeks
Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
Measured: 52 weeks
Use of Lipid Lowering Agents During the Study
Measured: 52 weeks
Body Mass Index Class (Kilograms/Square Meter)
Measured: 52 weeks
Total Cholesterol Over Time
Measured: 52 weeks
High Density Lipoprotein (HDL) Cholesterol Over Time
Measured: 52 weeks
Low Density Lipoprotein (HDL) Cholesterol Over Time
Measured: 52 weeks
Triglycerides Over Time
Measured: 52 weeks
Alanine Aminotransferase (ALT) Over Time
Measured: 52 weeks
Aspartate Aminotransferase (ALT) Over Time
Measured: 52 weeks
Gamma-glutamyl Transpeptidase (GGT) Over Time
Measured: 52 weeks
Creatinine Over Time
Measured: 52 weeks
Total Bilirubin Over Time
Measured: 52 weeks
Alkaline Phosphatase Over Time
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startAug 2006
- Primary completionJan 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
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531206
- Sponsor's protocol ID
- 1182.112
- Status last verified
- Feb 2014
- First submitted
- 17 Sep 2007
- Last updated
- 7 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients
- ClinicalTrials.gov ID
- NCT00531206
- Acronym / sponsor ID
- 1182.112
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2009 (actual)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Posted 12 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | 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 (1 listed)
- Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
Key exclusion criteria (7 listed)
- Age < 18 years
- pregnant female patients
- Hypersensitivity to the active substance or to any of the excipients.
- Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
- Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
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 | All participants |
| Ritonavirlow dose | Drug | All participants |
Primary outcome
Adverse Events
Time frame: 52 weeks
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
20 secondary outcomes
Change in Viral Load
Time frame: Baseline and 52 weeks
CD4+ Cell Count
Time frame: Baseline and 52 weeks
Subjective Well-being
Time frame: 52 weeks
Serious Adverse Events
Time frame: 52 weeks
Deaths
Time frame: 52 weeks
Discontinuations Due to an Adverse Event
Time frame: 52 weeks
Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion
Time frame: 52 weeks
Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
Time frame: 52 weeks
Use of Lipid Lowering Agents During the Study
Time frame: 52 weeks
Body Mass Index Class (Kilograms/Square Meter)
Time frame: 52 weeks
Total Cholesterol Over Time
Time frame: 52 weeks
High Density Lipoprotein (HDL) Cholesterol Over Time
Time frame: 52 weeks
Low Density Lipoprotein (HDL) Cholesterol Over Time
Time frame: 52 weeks
Triglycerides Over Time
Time frame: 52 weeks
Alanine Aminotransferase (ALT) Over Time
Time frame: 52 weeks
Aspartate Aminotransferase (ALT) Over Time
Time frame: 52 weeks
Gamma-glutamyl Transpeptidase (GGT) Over Time
Time frame: 52 weeks
Creatinine Over Time
Time frame: 52 weeks
Total Bilirubin Over Time
Time frame: 52 weeks
Alkaline Phosphatase Over Time
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
27 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 27 sites in Germany.
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 7 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 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany. 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 12 May 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?
Adverse Events (time frame: 52 weeks). 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 7 Apr 2014.