HIV InfectionsPhase 2NCT02238314
Exploratory Study of Tipranavir and Ritonavir in Multiple Protease Inhibitor-experienced HIV Patients
A Phase 2 study testing Tipranavir low dose, Tipranavir high dose and Ritonavir in people with HIV Infections, run by Boehringer Ingelheim.
Trial summary
The primary objective was to evaluate the antiviral activity and safety of two regimens of tipranavir (500 mg BID or 1000 mg BID) plus ritonavir (100 mg BID) administered in combination with 1 new nucleoside reverse transcriptase inhibitor (NRTI) + efavirenz in multiple protease-inhibitor-experienced HIV-1 positive… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tipranavir low dose, Tipranavir high dose and Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Aug 2001
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Multiple (two or more) PI-experience. Eligible patients must have had exposure to at least two antiretroviral regimens containing a single protease inhibitor or a regimen containing dual protease inhibitors
- In the investigator's opinion, the patient had adhered to PI-containing regimens
- Exposure of ≥ 3 months to the current PI therapy
- Exposure of ≥ 4 months to the prior PI therapy with single PI-containing regimens
- Stable PI-containing regimen for at least 2 months prior to study entry
- HIV-1-RNA ≥ 5,000 copies/mL
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- Cluster of differentiation (CD)4+ cell count ≥ 50 cells/mm**3
- At least one new NRTI option available
- Age ≥ 13 years
- Acceptable screening laboratory values that indicated adequate baseline organ function at the time of screening. Laboratory values were considered acceptable if the severity was ≤ Grade 1 (AIDS Clinical Trial Group (ACTG) Grading Scale). Stable Grade 2 abnormalities were permitted if the values had been demonstrated and documented for at least ≥ 2 months.
- Acceptable medical history, physical examination, electrocardiogram, and chest X-ray prior to entry into the treatment phase of the study
- Agreement to use a barrier contraceptive method of birth control for at least 30 days prior to study drug administration, during the study, and 30 days after the end of the study
- Ability to swallow numerous tablets and capsules without difficulty
- Ability to understand and provide informed consent. Minors were required to have approval of a parent or legal guardian
Who cannot join
- Prior exposure, defined as > 7 treatment days, to nonnucleoside reverse transcriptase inhibitor (NNRTIs) including, but not limited to: nevirapine, efavirenz, delavirdine, atevirdine, MKC-442, loviride, and HBY-097
- Clinically significant active or acute (onset within the month previous to study entry) medical problems, including the following: opportunistic infections, such as active cryptococcosis, Pneumocystis carinii pneumonia, herpes zoster, histoplasmosis, or cytomegalovirus or nonopportunistic diseases, including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
- Prior exposure (> 7 days) to tipranavir
- History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair adherence to the protocol
- Taking of any known P450 3A enzyme-inducing drugs within 30 days of study entry and including the following: rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfadimidine, sulfinpyrazone, or troleandomycin
- Hypersensitivity to tipranavir and/or ritonavir
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- Use of interferons, interleukins, HIV vaccines, or any active immunizations within 30 days prior to study entry
- Taking of any investigational medication with the exception of adefovir dipivoxil (Preveon™) and amprenavir (Agenerase™) within 30 days of study entry
- Pregnancy or lactation (serum β-human chorionic gonadotrophin test had to have been negative within 14 days of study entry)
- Evidence of active substance abuse, which in the investigator's opinion, could affect compliance to the protocol
- In the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified
About this study
Official title: Tipranavir Disodium: An Open-Label ExploratorySstudy of Tipranavir and Ritonavir in Combination With One Nucleoside Reverse Transcriptase Inhibitor and One Non-Nucleoside Reverse Transcriptase Inhibitor in Multiple Protease Inhibitor-Experienced HIV Patients
The primary objective was to evaluate the antiviral activity and safety of two regimens of tipranavir (500 mg BID or 1000 mg BID) plus ritonavir (100 mg BID) administered in combination with 1 new nucleoside reverse transcriptase inhibitor (NRTI) + efavirenz in multiple protease-inhibitor-experienced HIV-1 positive patients.
- Conditions
- HIV Infections
- Being tested
- Tipranavir low dose, Tipranavir high dose, Ritonavir, Nucleoside Reverse Transcriptase Inhibitor (NRTI), Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tipranavir low doseDrug
Tipranavir high doseDrug
RitonavirDrug
Nucleoside Reverse Transcriptase Inhibitor (NRTI)Drug
Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)Drug
| Study group | Role | What they receive |
|---|---|---|
| Tipranavir low dose | Experimental | Not described Receives: Drug: Tipranavir low dose; Drug: Ritonavir; Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI); Drug: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) |
| Tipranavir high dose | Experimental | Not described Receives: Drug: Tipranavir high dose; Drug: Ritonavir; Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI); Drug: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HIV-1 RNA concentrations
Measured: weeks 16, 24, 48 and 80
Occurrence of HIV-1 RNA levels below the limit of quantitation (BLQ) (400 copies/mL)
measured by the Roche Amplicor HIV-1 Monitor™ polymerase chain reaction (PCR) Method
Measured: up to 112 weeks
Occurrence of HIV-1 RNA levels BLQ (50 copies/mL)
measured by the Roche Amplicor UltraSensitive™ PCR Method
Measured: up to 112 weeks
Number of patients with treatment-emergent and drug-related adverse events (AEs)
Measured: up to 115 weeks
Number of patients with serious adverse events (SAEs)
Measured: up to 115 weeks
Number of patients with grade 3 and 4 laboratory abnormalities
Measured: up to 115 weeks
Secondary outcomes (15)
Change from baseline in cluster of differentiation (CD) 4+ cell count responses
Measured: weeks 24, 48 and 80
Change from baseline in CD8+ cell count responses
Measured: weeks 24, 48 and 80
Time to new or recurring AIDS-defining illness
Measured: up to 115 weeks
Time to new or recurring HIV-related illness
Measured: up to 115 weeks
Time to death
Measured: up to 115 weeks
Occurrence of AIDS-defining illness,
Measured: up to 115 weeks
Occurrence of HIV-related illness,
Measured: up to 115 weeks
Occurrence of death
Measured: up to 115 weeks
Time to virologic failure
defined as plasma HIV-1 RNA values >400 copies/mL or a 0.5 log reduction from baseline at two consecutive time points
Measured: up to 115 weeks
Change from baseline in cholesterol
Measured: up to 115 weeks
Change from baseline in HDL
Measured: up to 115 weeks
Change from baseline in triglycerides
Measured: up to 115 weeks
Change from baseline in blood glucose
Measured: up to 115 weeks
Steady-state plasma concentrations
Measured: up to week 24
Fold-change in concentration required to produce 50% of inhibition (IC 50)
sequence-based HIV-1 analysis (genotyping) and drugs susceptibility assays (phenotyping)
Measured: Baseline, weeks 24, 48 and 80
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startJan 1999
- Primary completionAug 2001
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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238314
- Sponsor's protocol ID
- 1182.2
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tipranavir Disodium: An Open-Label ExploratorySstudy of Tipranavir and Ritonavir in Combination With One Nucleoside Reverse Transcriptase Inhibitor and One Non-Nucleoside Reverse Transcriptase Inhibitor in Multiple Protease Inhibitor-Experienced HIV Patients
- ClinicalTrials.gov ID
- NCT02238314
- Acronym / sponsor ID
- 1182.2
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Aug 2001 (actual)
- First posted
- 12 Sep 2014 (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 primary objective was to evaluate the antiviral activity and safety of two regimens of tipranavir (500 mg BID or 1000 mg BID) plus ritonavir (100 mg BID) administered in combination with 1 new nucleoside reverse transcriptase inhibitor (NRTI) + efavirenz in multiple protease-inhibitor-experienced HIV-1 positive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tipranavir low dose | Experimental | Drug: Tipranavir low dose, Drug: Ritonavir, Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI), Drug: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) |
| Tipranavir high dose | Experimental | Drug: Tipranavir high dose, Drug: Ritonavir, Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI), Drug: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Multiple (two or more) PI-experience. Eligible patients must have had exposure to at least two antiretroviral regimens containing a single protease inhibitor or a regimen containing dual protease inhibitors
- In the investigator's opinion, the patient had adhered to PI-containing regimens
- Exposure of ≥ 3 months to the current PI therapy
- Exposure of ≥ 4 months to the prior PI therapy with single PI-containing regimens
- Stable PI-containing regimen for at least 2 months prior to study entry
Key exclusion criteria (11 listed)
- Prior exposure, defined as > 7 treatment days, to nonnucleoside reverse transcriptase inhibitor (NNRTIs) including, but not limited to: nevirapine, efavirenz, delavirdine, atevirdine, MKC-442, loviride, and HBY-097
- Clinically significant active or acute (onset within the month previous to study entry) medical problems, including the following: opportunistic infections, such as active cryptococcosis, Pneumocystis carinii pneumonia, herpes zoster, histoplasmosis, or cytomegalovirus or nonopportunistic diseases, including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
- Prior exposure (> 7 days) to tipranavir
- History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair adherence to the protocol
- Taking of any known P450 3A enzyme-inducing drugs within 30 days of study entry and including the following: rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfadimidine, sulfinpyrazone, or troleandomycin
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 low dose | Drug | Tipranavir low dose |
| Tipranavir high dose | Drug | Tipranavir high dose |
| Ritonavir | Drug | Tipranavir high dose, Tipranavir low dose |
| Nucleoside Reverse Transcriptase Inhibitor (NRTI) | Drug | Tipranavir high dose, Tipranavir low dose |
| Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) | Drug | Tipranavir high dose, Tipranavir low dose |
Primary outcome
Change from baseline in HIV-1 RNA concentrations
Time frame: weeks 16, 24, 48 and 80
Occurrence of HIV-1 RNA levels below the limit of quantitation (BLQ) (400 copies/mL)
Time frame: up to 112 weeks
measured by the Roche Amplicor HIV-1 Monitor™ polymerase chain reaction (PCR) Method
Occurrence of HIV-1 RNA levels BLQ (50 copies/mL)
Time frame: up to 112 weeks
measured by the Roche Amplicor UltraSensitive™ PCR Method
Number of patients with treatment-emergent and drug-related adverse events (AEs)
Time frame: up to 115 weeks
Number of patients with serious adverse events (SAEs)
Time frame: up to 115 weeks
Number of patients with grade 3 and 4 laboratory abnormalities
Time frame: up to 115 weeks
15 secondary outcomes
Change from baseline in cluster of differentiation (CD) 4+ cell count responses
Time frame: weeks 24, 48 and 80
Change from baseline in CD8+ cell count responses
Time frame: weeks 24, 48 and 80
Time to new or recurring AIDS-defining illness
Time frame: up to 115 weeks
Time to new or recurring HIV-related illness
Time frame: up to 115 weeks
Time to death
Time frame: up to 115 weeks
Occurrence of AIDS-defining illness,
Time frame: up to 115 weeks
Occurrence of HIV-related illness,
Time frame: up to 115 weeks
Occurrence of death
Time frame: up to 115 weeks
Time to virologic failure
Time frame: up to 115 weeks
Change from baseline in cholesterol
Time frame: up to 115 weeks
Change from baseline in HDL
Time frame: up to 115 weeks
Change from baseline in triglycerides
Time frame: up to 115 weeks
Change from baseline in blood glucose
Time frame: up to 115 weeks
Steady-state plasma concentrations
Time frame: up to week 24
Fold-change in concentration required to produce 50% of inhibition (IC 50)
Time frame: Baseline, weeks 24, 48 and 80
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 12 Sep 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tipranavir low dose, Tipranavir high dose and Ritonavir in people with HIV Infections, run by Boehringer Ingelheim.
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 14 inclusion and 11 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in HIV-1 RNA concentrations (time frame: weeks 16, 24, 48 and 80). The study lists 6 primary outcomes in all. 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 12 Sep 2014.