HIV InfectionsPhase 2NCT00275444
3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
A Phase 2 study testing Tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 62 sites in 9 countries.
Trial summary
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic… 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
- 216 participants
- Where
- 62 sitesin 9 countries
- Study dates
- 29 Mar 2002to 20 Jan 2003
- Phase
- Phase 2
- 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
Who may be able to join
- Signed informed consent prior to trial participation.
- Human immunodeficiency virus 1 (HIV-1) infected males or females > 18 years of age.
- At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).
- Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
- HIV-1 viral load ≥1000 copies/mL at screening.
- Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M.
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- Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance".
- Acceptable screening laboratory values that indicate adequate baseline organ function.
- Laboratory values are considered to be acceptable if severity is no higher than Grade 3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the "Division of Acquired Immune Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI).
- Further inclusion criteria apply.
Who cannot join
- ARV medication naïve.
- Only one or no available ARV medications as determined by genotypic resistance testing.
- Female subjects who:
- have a positive serum pregnancy test at screening or during the study;
- are breast feeding;
- are planning to become pregnant;
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- are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam).
- Any active opportunistic infection within 60 days before study entry.
- Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > Grade 1.
- Prior tipranavir use.
- Use of investigational medications within 30 days before study entry or during the trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.
- Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
- Further exclusion criteria apply.
Trial locations and contacts
62 sites in 9 countries.
62 sites in 9 countries
United States38 sites
Albany Medical College
Albany, New York
University of Michigan Health System
Ann Arbor, Michigan
Boehringer Ingelheim Investigational Site
Annandale, Virginia
Boehringer Ingelheim Investigational Site
Atlanta, Georgia
John's Hopkins University
Baltimore, Maryland
Boehringer Ingelheim Investigational Site
Boston, Massachusetts
CORE Center
Chicago, Illinois
Rush-Presbytarian-St Luke's Medical Center
Chicago, Illinois
Boehringer Ingelheim Investigational Site
Columbia, South Carolina
Ohio State University Medical Center
Columbus, Ohio
Atlanta VA Medical Center
Decatur, Georgia
Duke University Medical Center
Durham, North Carolina
Therafirst Medical Center
Fort Lauderdale, Florida
Boehringer Ingelheim Investigational Site
Fountain Valley, California
ID Care
Hillsborough, New Jersey
Boehringer Ingelheim Investigational Site
Houston, Texas
Boehringer Ingelheim Investigational Site
Huntersville, North Carolina
Boehringer Ingelheim Investigational Site
Kansas City, Missouri
Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
Living Hope Clinical Trials, Inc.
Long Beach, California
Boehringer Ingelheim Investigational Site
Los Angeles, California
David Geffen School of Medicine at UCLA
Los Angeles, California
University of Louisville
Louisville, Kentucky
Mercer University School of Medicine
Macon, Georgia
1501 N.W. 9th Ave
Miami, Florida
HIV Outpatient Program (H.O.P)
New Orleans, Louisiana
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
Boehringer Ingelheim Investigational Site
Orlando, Florida
Boehringer Ingelheim Investigational Site
Phoenix, Arizona
Boehringer Ingelheim Investigational Site
Santa Fe, New Mexico
Boehringer Ingelheim Investigational Site
South Miami, Florida
Community Research Initiative of New England
Springfield, Massachusetts
Washington University
St Louis, Missouri
University of New York at Stony Brook
Stony Brook, New York
Hillsborough County Health Dept.
Tampa, Florida
Boehringer Ingelheim Investigational Site
Vero Beach, Florida
Vincent Lombardi Cancer Center
Washington D.C., District of Columbia
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina
France6 sites
Hôpital de Bicêtre
Le Kremlin-Bicêtre
Hôpital de Chauliac
Montpellier
Hôpital Hôtel Dieu
Nantes
Hôpital Bichat Claude Bernard
Paris
Hôpital de la pitié Salpetrière
Paris
Hôpital Saint Louis
Paris
Germany4 sites
Epimed GmbH
Berlin
Klinik I für Innere Medizin der
Cologne
Klinikum der J.-W.-Goethe-Universität
Frankfurt am Main
Medizinische Poliklinik
München
Spain4 sites
Hospital Clínico y Provincial de Barcelona - HIV
Barcelona
Boehringer Ingelheim Investigational Site
Madrid
Hospital La Paz.
Madrid
Hospital Ramón y Cajal.
Madrid
Canada3 sites
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec
Boehringer Ingelheim Investigational Site
Ottawa, Ontario
Toronto General Hospital
Toronto, Ontario
Australia2 sites
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales
St. Vincent's Hospital
Darlinghurst, New South Wales
Italy2 sites
Fondazione Centro S. Raffaele del Monte Tabor
Milan
IRCCS Policlinico San Matteo
Pavia
Netherlands2 sites
Academisch Medisch Centrum
Amsterdam
Erasmus Medical Centre
Rotterdam
United Kingdom1 site
4th Floor Research Office (St Stephens Centre)
London
About this study
Official title: Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.
- 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.
Virologic response after 2 weeks of functional monotherapy
Measured: At week 2
Secondary outcomes (1)
Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study start29 Mar 2002
- Primary completion20 Jan 2003
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275444
- Sponsor's protocol ID
- 1182.52
- Status last verified
- Nov 2023
- First submitted
- 9 Jan 2006
- Last updated
- 1 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects
- ClinicalTrials.gov ID
- NCT00275444
- Acronym / sponsor ID
- 1182.52
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2002 (actual)
- Primary completion
- 20 Jan 2003 (actual)
- First posted
- 12 Jan 2006 (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.
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent prior to trial participation.
- Human immunodeficiency virus 1 (HIV-1) infected males or females > 18 years of age.
- At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).
- Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
- HIV-1 viral load ≥1000 copies/mL at screening.
Key exclusion criteria (13 listed)
- ARV medication naïve.
- Only one or no available ARV medications as determined by genotypic resistance testing.
- Female subjects who:
- Any active opportunistic infection within 60 days before study entry.
- Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > Grade 1.
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
Virologic response after 2 weeks of functional monotherapy
Time frame: At week 2
1 secondary outcome
Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.
Time frame: Up to 24 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 1 Dec 2023.
- Related InfoLink provided by the sponsor.
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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 Coordinator study chair
Boehringer Ingelheim
62 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 62 sites in 9 countries.
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 10 inclusion and 13 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, France, Germany, Spain, Canada and 4 more countries. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Virologic response after 2 weeks of functional monotherapy (time frame: At week 2). 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 1 Dec 2023.