HIV InfectionsPhase 2NCT00034866
Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals
A Phase 2 study testing Protease inhibitor tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 51 sites in 2 countries.
Trial summary
The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. 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?
- Protease inhibitor tipranavir
- How many people
- 165 participants
- Where
- 51 sitesin 2 countries
- Study dates
- Apr 2002to Oct 2002
- 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.
- HIV-1 infected males or females >= 18 years of age.
- At least 3 months experience taking NRTIs, NNRTI(s), and PIs.
- Current PI-based 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, with not more than one of 82 A/F/T or 84V or 90M.
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- 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 GGT, Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the DAIDS Grading Scale. All laboratory values outside these limits are subject to approval by BI.
- Acceptable medical history, as assessed by the investigator, with chest X-ray and ECG within 1 year of study participation.
- Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system, such as: grapefruit or Seville oranges or their products; herbal preparations containing St. John's Wort or milk thistle, and garlic supplements.
- A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment for at least 2 months.
Who cannot join
- ARV medication naïve.
- Female subjects who:
- have a positive serum pregnancy test at screening or during the study
- are breast feeding
- are planning to become pregnant
- are not willing to use two barrier methods of contraception (e.g. latex condom plus spermicidal jelly/foam).
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- Any active opportunistic infection within 60 days before study entry.
- Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/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.
- Use of immunomodulatory drugs (e.g. interferon, cyclosporin, hydroxyurea, interleukin-2).
- Active substance abuse.
- Inability to swallow TPV or RTV capsules.
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States50 sites
Albany Medical College
Albany, New York, 12208
(IDC) Research Institute
Altamonte Springs, Florida, 32701
University of Michigan Health System
Ann Arbor, Michigan, 48109
Infectious Disease Physicians Research
Annandale, Virginia, 22003
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
John's Hopkins University School of Medicine
Baltimore, Maryland, 21205
Community Research Initiative of New England
Boston, Massachusetts, 02125
University of North Carolina
Chapel Hill, North Carolina, 27599
CORE Center, Cook County Hospital
Chicago, Illinois, 60612
Rush Presbyterian/St. Luke's Medical Center
Chicago, Illinois, 60612
Burnside Clinic
Columbia, South Carolina, 29206
Ohio State University Medical Center
Columbus, Ohio, 43210
Nelson-Tebedo Clinic
Dallas, Texas, 75219
Atlanta VA Medical Center, Dept. of ID
Decatur, Georgia, 30033
Henry Ford Hospital, Infectious Diseases Dept.
Detroit, Michigan, 48202
Duke University Medical Center Infectious Diseases Clinic
Durham, North Carolina, 27710
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
Orange County Center for Special Immunology
Fountain Valley, California, 92708
ID Care, Inc.
Hillsborough, New Jersey, 08844
Gathe Clinic
Houston, Texas, 77004
Jemsek Clinic
Huntersville, North Carolina, 28078
Kansas City Free Health Clinic
Kansas City, Missouri, 64111
Wellness Center
Las Vegas, Nevada, 89102
Living Hope Clinical Trials Inc.
Long Beach, California, 90813
AHF Research Center
Los Angeles, California, 90027
University of So. California / LA County USC Medical Center
Los Angeles, California, 90033
ID Care, Inc.
Los Angeles, California, 90046
Tower I.D. Medical Assoc., Inc.
Los Angeles, California, 90048
University of California, Los Angeles Medical Center
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
Mercer University School of Medicine
Macon, Georgia, 31207
Jackson Medical Tower
Miami, Florida, 33136
Vanderbilt University - AIDS Clinical Trial Unit
Nashville, Tennessee, 37203
HIV Outpatient Program (H.O.P.)
New Orleans, Louisiana, 70112
Mount Sinai School of Medicine
New York, New York, 10029
Infect. Disease Institute, Clinical Trials Unit
Oklahoma City, Oklahoma, 73104
Phoenix Body Positive
Phoenix, Arizona, 85006
ID Care, Inc.
Randolph Township, New Jersey, 07869
University of California San Francisco Positive Health Program Research
San Francisco, California, 94110
Pacific Horizon Medial Group
San Francisco, California, 94115
Southwest CARE Center
Santa Fe, New Mexico, 97505
Steinhart Medical Associates
South Miami, Florida, 33133
CRI Community Research Initiative
Springfield, Massachusetts, 01107
Washington University AIDS Clinical Trial Unit
St Louis, Missouri, 63108
University of New York at Stony Brook
Stony Brook, New York, 11794
Hillsborough County Health Dept.
Tampa, Florida, 33602
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
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.
The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1.
Read the detailed description
This study will be conducted in HIV+, multiple ARV medication experienced patients. All patients must have received treatment from each of three ARV classes: NRTIs, NNRTIs and PIs, have received at least two PI-based ARV regimens (may include the current regimen) with a viral load greater than or equal to 1000 copies/mL at the time of study entry. The two separate PI-based regimens must each have been taken for at least 3 months. At least one resistance-conferring PI-mutation (from a pre-established panel) must be present. Baseline genotypic screening will be performed and will be used in conjunction with ARV medication history to determine new background therapy for each individual subject to use.
Following genotypic screening at baseline, qualifying subjects will be randomized to one of three blinded treatment regimens. Subjects will discontinue their current protease inhibitor and initiate TPV/RTV for 2 weeks of functional monotherapy. Thereafter, the background ARV medications will be optimized and subjects will remain on blinded TPV/RTV plus optimized background therapy for the duration of the trial. Trial duration ranges between 12-32 weeks, depending on when the subject is entered into the trial and the interim analyses for determination of optimized TPV/RTV regimen is completed. On determination of the optimal TPV/RTV dose, subjects may opt to continue open-label treatment.
- Conditions
- HIV Infections
- Being tested
- Protease inhibitor tipranavir
- Keywords
- HIV, treatment experienced, Boehringer, 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.
Protease inhibitor tipranavirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startApr 2002
- Study completionOct 2002
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
- 165 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034866
- Sponsor's protocol ID
- BI 1182.52
- Status last verified
- Sep 2005
- First submitted
- 2 May 2002
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. 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
- NCT00034866
- Acronym / sponsor ID
- BI 1182.52
- Conditions
- HIV Infections
- Keywords
- HIV, treatment experienced, Boehringer, tipranavir, ritonavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Oct 2002
- First posted
- 3 May 2002 (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.
The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1.
Detailed description
This study will be conducted in HIV+, multiple ARV medication experienced patients. All patients must have received treatment from each of three ARV classes: NRTIs, NNRTIs and PIs, have received at least two PI-based ARV regimens (may include the current regimen) with a viral load greater than or equal to 1000 copies/mL at the time of study entry. The two separate PI-based regimens must each have been taken for at least 3 months. At least one resistance-conferring PI-mutation (from a pre-established panel) must be present. Baseline genotypic screening will be performed and will be used in conjunction with ARV medication history to determine new background therapy for each individual subject to use.
Following genotypic screening at baseline, qualifying subjects will be randomized to one of three blinded treatment regimens. Subjects will discontinue their current protease inhibitor and initiate TPV/RTV for 2 weeks of functional monotherapy. Thereafter, the background ARV medications will be optimized and subjects will remain on blinded TPV/RTV plus optimized background therapy for the duration of the trial. Trial duration ranges between 12-32 weeks, depending on when the subject is entered into the trial and the interim analyses for determination of optimized TPV/RTV regimen is completed. On determination of the optimal TPV/RTV dose, subjects may opt to continue open-label treatment.
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.
- HIV-1 infected males or females >= 18 years of age.
- At least 3 months experience taking NRTIs, NNRTI(s), and PIs.
- Current PI-based 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 (14 listed)
- ARV medication naïve.
- Female subjects who:
- Any active opportunistic infection within 60 days before study entry.
- Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT >Grade 1.
- Prior tipranavir use.
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 |
|---|---|---|
| Protease inhibitor tipranavir | Drug | – |
Primary outcome
Not reported in the source record.
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 20 Sep 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Protease inhibitor tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 51 sites in 2 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 14 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 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Puerto Rico. 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.
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 20 Sep 2005.