HIV InfectionsPhase 1/2NCT02251223
Effects of Tipranavir/Ritonavir on the Pharmacokinetic Characteristics of Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects
A Phase 1/2 study testing Tipranavir low dose, Tipranavir medium dose and Tipranavir high dose in people with HIV Infections, run by Boehringer Ingelheim.
Trial summary
Primary: Sequentially determine the effects of three dose combinations of tipranavir (TPV) / ritonavir (RTV) (administered b.i.d.), TPV 1250 mg/RTV 100 mg vs. TPV 750 mg/RTV 100 mg vs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tipranavir low dose, Tipranavir medium dose and Tipranavir high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Feb 2002
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to trial participation
- Between 18 and 75 years of age inclusive
- Female subjects of child bearing potential are required to use a barrier contraceptive method for at least 12 weeks prior to administration of study medication, during study medication administration, and for 28 days after the end of the study
- Ability to swallow capsules without difficulty
- A Body Mass Index (BMI) between 11 and 50 kg/m2
- Reasonable probability for completion of the study
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- Acceptable screening laboratory values. All laboratory values ≤ Grade I (e.g., creatine phosphokinase (CPK), amylase, triglycerides) are permissible if documentation of stability for 2 months or more is available. Abnormalities > Grade I are subject to approval by BI clinical monitor or designee
- Acceptable medical history, physical examination, ECG, and chest X-ray prior to entering the treatment phase of the study
- Willingness to abstain from alcohol from Day -2 to Day 23
- Willingness to abstain from ingesting grapefruit, grapefruit juice, Seville oranges or orange marmalade from Day -2 to Day 23
- Negative urine drug screen for drugs of abuse. Subjects on methadone or equivalent narcotic maintenance programs will be permitted to enter the study
- Documented HIV-1 RNA load (by PCR) at screening of ≤20,000 copies/mL for at least twelve weeks. Acceptable documentation would include laboratory data, a letter or a verbal report from another provider noted in the subject records.
- Stable doses of approved NRTIs and NNRTIs 2 for a minimum of twelve weeks prior to study Day 0. Subjects on efavirenz must be able to tolerate daily morning (8:00 a.m.) dosing starting at screening period and for 22 days of the study. Subjects receiving bid ddI must be willing to accept a change to the once a day delayed release (EC) formulation
Who cannot join
- Female subjects who:
- have a positive serum pregnancy test at Screening Period Day -14 to -7
- are breast feeding
- Receipt of any other investigational medicine for 30 days prior to Day 0
- Receipt of any known cytochrome P450 3A4 (CYP3A4) altering drug i.e. phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids and herbal medications for 30 days prior to Day 0. No antibiotics permitted within 10 days prior to Day 0
- Ingestion of grapefruit, grapefruit juice, Seville oranges or orange marmalade within 2 days of study entry (Day 0)
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- Blood or plasma donations (>100 ml total) for research or altruistic reasons within 30 days prior to Day 0
- Seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/minute or >90 beats/minute
- History of any illness, including malabsorption, irregular food intake or gastrointestinal intolerance, or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering TPV/RTV
- Any acute illness within 2 weeks prior to Day 0
- Subjects who are currently taking any over-the-counter drug within 7 days prior to Day 0, or who are currently taking any prescription drug that, in the opinion of the investigator (in consultation with the BI medical monitor and/or pharmacokineticist), might interfere with either the absorption, distribution or metabolism of the TPV/RTV
- Hypersensitivity to TPV, RTV or sulfonamide containing drugs
- Using the adherence diary, subject has less than 100% documented adherence for the last 14 doses (7 days) of baseline antiretroviral medications prior to Day 0. Subjects has less than 100% adherence for the last 7 doses (7 days) of efavirenz and ddI (delayed release) prior to Day 0
About this study
Official title: An Open Label Multinational Study of the Effects of Three Dose Pairs of Tipranavir/Ritonavir (b.i.d.) on the Pharmacokinetic Characteristics of Protocol -Defined, Baseline, Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects.
Primary: Sequentially determine the effects of three dose combinations of tipranavir (TPV) / ritonavir (RTV) (administered b.i.d.), TPV 1250 mg/RTV 100 mg vs. TPV 750 mg/RTV 100 mg vs. TPV 250 mg/RTV 200 mg on the steady-state pharmacokinetics of zidovudine, lamivudine, stavudine, didanosine, abacavir, nevirapine and efavirenz at approved doses. The three treatment groups will be enrolled sequentially starting with the highest tipranavir dosage group first and ending with the lowest tipranavir dosage group.
Secondary: A) To assess the effects of zidovudine, lamivudine, stavudine, didanosine, abacavir, nevirapine, and efavirenz on the pharmacokinetics of tipranavir/ritonavir compared to historical controls.
- To assess the safety of three tipranavir/ritonavir combinations when used in combination with protocol defined antiretrovirals.
- Conditions
- HIV Infections
- Being tested
- Tipranavir low dose, Tipranavir medium dose, Tipranavir high dose, Ritonavir low dose, Ritonavir high dose
- 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 medium doseDrug
Tipranavir high doseDrug
Ritonavir low doseDrug
Ritonavir high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| TPV/r low dose | Experimental | Not described Receives: Drug: Tipranavir low dose; Drug: Ritonavir high dose |
| TPV/r medium dose | Experimental | Not described Receives: Drug: Tipranavir medium dose; Drug: Ritonavir low dose |
| TPV/r high dose | Experimental | Not described Receives: Drug: Tipranavir high dose; Drug: Ritonavir low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trough plasma concentration (Cmin,ss) for non-nucleoside reverse transcriptase inhibitor (NNRTI)
stratified by substance
Measured: baseline, up to day 23
Change in area under plasma concentration-time curve over dosing interval (AUC0-τ) for nucleoside reverse transcriptase inhibitor (NRTI)
stratified by substance
Measured: baseline, up to day 22
Change in area under plasma concentration-time curve from 0 to 12 hours for didanosine (ddI)
Measured: baseline, up to day 22
Secondary outcomes (10)
Cmin,ss
stratified by substance
Measured: up to day 23
AUC0-τ
stratified by substance
Measured: up to day 23
Maximum plasma concentration (Cmax)
stratified by substance
Measured: up to day 23
Time of maximum plasma concentration (Tmax)
stratified by substance
Measured: up to day 23
Oral clearance (Cl/F)
stratified by substance
Measured: up to day 23
Apparent terminal half life (t1/2)
stratified by substance
Measured: up to day 23
Change in CD4 cell count
Measured: up to day 23
Change in HIV-1 RNA levels
Measured: up to day 23
Number of patients with clinically significant findings in laboratory tests
Measured: up to 25 weeks
Number of patients with adverse events
Measured: up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startFeb 2001
- Primary completionFeb 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 208 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
- NCT02251223
- Sponsor's protocol ID
- 1182.6
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multinational Study of the Effects of Three Dose Pairs of Tipranavir/Ritonavir (b.i.d.) on the Pharmacokinetic Characteristics of Protocol -Defined, Baseline, Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects.
- ClinicalTrials.gov ID
- NCT02251223
- Acronym / sponsor ID
- 1182.6
- Conditions
- HIV Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Feb 2002 (actual)
- First posted
- 29 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.
Primary: Sequentially determine the effects of three dose combinations of tipranavir (TPV) / ritonavir (RTV) (administered b.i.d.), TPV 1250 mg/RTV 100 mg vs. TPV 750 mg/RTV 100 mg vs. TPV 250 mg/RTV 200 mg on the steady-state pharmacokinetics of zidovudine, lamivudine, stavudine, didanosine, abacavir, nevirapine and efavirenz at approved doses. The three treatment groups will be enrolled sequentially starting with the highest tipranavir dosage group first and ending with the lowest tipranavir dosage group.
Secondary: A) To assess the effects of zidovudine, lamivudine, stavudine, didanosine, abacavir, nevirapine, and efavirenz on the pharmacokinetics of tipranavir/ritonavir compared to historical controls.
- To assess the safety of three tipranavir/ritonavir combinations when used in combination with protocol defined antiretrovirals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TPV/r low dose | Experimental | Drug: Tipranavir low dose, Drug: Ritonavir high dose |
| TPV/r medium dose | Experimental | Drug: Tipranavir medium dose, Drug: Ritonavir low dose |
| TPV/r high dose | Experimental | Drug: Tipranavir high dose, Drug: Ritonavir low dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent prior to trial participation
- Between 18 and 75 years of age inclusive
- Female subjects of child bearing potential are required to use a barrier contraceptive method for at least 12 weeks prior to administration of study medication, during study medication administration, and for 28 days after the end of the study
- Ability to swallow capsules without difficulty
- A Body Mass Index (BMI) between 11 and 50 kg/m2
Key exclusion criteria (13 listed)
- Female subjects who:
- Receipt of any other investigational medicine for 30 days prior to Day 0
- Receipt of any known cytochrome P450 3A4 (CYP3A4) altering drug i.e. phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids and herbal medications for 30 days prior to Day 0. No antibiotics permitted within 10 days prior to Day 0
- Ingestion of grapefruit, grapefruit juice, Seville oranges or orange marmalade within 2 days of study entry (Day 0)
- Blood or plasma donations (>100 ml total) for research or altruistic reasons within 30 days prior to Day 0
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 | TPV/r low dose |
| Tipranavir medium dose | Drug | TPV/r medium dose |
| Tipranavir high dose | Drug | TPV/r high dose |
| Ritonavir low dose | Drug | TPV/r high dose, TPV/r medium dose |
| Ritonavir high dose | Drug | TPV/r low dose |
Primary outcome
Change in trough plasma concentration (Cmin,ss) for non-nucleoside reverse transcriptase inhibitor (NNRTI)
Time frame: baseline, up to day 23
stratified by substance
Change in area under plasma concentration-time curve over dosing interval (AUC0-τ) for nucleoside reverse transcriptase inhibitor (NRTI)
Time frame: baseline, up to day 22
stratified by substance
Change in area under plasma concentration-time curve from 0 to 12 hours for didanosine (ddI)
Time frame: baseline, up to day 22
10 secondary outcomes
Cmin,ss
Time frame: up to day 23
AUC0-τ
Time frame: up to day 23
Maximum plasma concentration (Cmax)
Time frame: up to day 23
Time of maximum plasma concentration (Tmax)
Time frame: up to day 23
Oral clearance (Cl/F)
Time frame: up to day 23
Apparent terminal half life (t1/2)
Time frame: up to day 23
Change in CD4 cell count
Time frame: up to day 23
Change in HIV-1 RNA levels
Time frame: up to day 23
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 25 weeks
Number of patients with adverse events
Time frame: up to 25 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 29 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 1/2 study testing Tipranavir low dose, Tipranavir medium dose and Tipranavir high dose 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 13 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 29 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 in trough plasma concentration (Cmin,ss) for non-nucleoside reverse transcriptase inhibitor (NNRTI) (time frame: baseline, up to day 23). The study lists 3 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 29 Sep 2014.