HIV InfectionsPhase 2NCT02249130
Tipranavir Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients Report on the Post-study Option, a Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir
A Phase 2 study testing Tipranavir (TPV), Ritonavir (RTV) and Delavirdine (DLV) in people with HIV Infections, run by Boehringer Ingelheim.
Trial summary
To investigate the safety of a standard triple therapy regimen of delavirdine (DLV), zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with regimens of tipranavir (TPV) with and without ritonavir (RTV) 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 (TPV), Ritonavir (RTV) and Delavirdine (DLV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Mar 1999to Apr 2000
- 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
- HIV-1 RNA ≥ 5,000 copies/mL by Roche Amplicor assay
- CD4 cell count ≥ 50 cells/mm3
- Karnofsky performance status ≥ 80
- Age ≥ 13 years
- Screening laboratory values indicative of adequate baseline organ function, Grade 0 or 1 for laboratory values based on the ACTG toxicity scale grade. Selected stable [2 months or longer] Grade 2 laboratory abnormalities were subject to sponsor's approval
- Acceptable medical history and physical examination
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- Agreement to use a barrier contraceptive method for at least 1 month prior to the administration of the study medication, during the study, and for 30 days after the end of the study
- Signed informed consent
- To enter the post-study option, patients have to have completed the 14-day tipranavir phase of the trial
Who cannot join
- Previous treatment with any antiretroviral drugs for more than 2 weeks
- Clinically significant, active and/or acute (onset within the prior month) medical problems including opportunistic infections, such as active cryptococcosis, Pneumocystis carinii pneumonia (PCP), herpes zoster, histoplasmosis or cytomegalovirus (CMV) , or non-opportunistic diseases including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
- History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair compliance with the study
- Receipt of any known enzyme-inducing drugs including rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfamidine, sulfinpyrazone, or troleandomycin within 30 days prior to participation in the study
- Receipt of any investigational medication within 30 days prior to participation in the study
- Receipt of oral contraceptives within 30 days prior to participation in the study
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- Pregnancy or lactation (serum ß-human chorionic gonadotropin (ß-HCG) test negative at second screen visit of the tipranavir phase of trial)
- Evidence of active substance abuse that, in the investigator's opinion, could affect study adherence
- In the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified above
About this study
Official title: Tipranavir (PNU-140690): A Fourteen Day Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients. Report on the Post-study Option, a 46-week Treatment Period of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir
To investigate the safety of a standard triple therapy regimen of delavirdine (DLV), zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with regimens of tipranavir (TPV) with and without ritonavir (RTV)
- Conditions
- HIV Infections
- Being tested
- Tipranavir (TPV), Ritonavir (RTV), Delavirdine (DLV), Zidovudine (ZDV), Lamivudine (3TC)
- 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 (TPV)Drug
Ritonavir (RTV)Drug
Delavirdine (DLV)Drug
Zidovudine (ZDV)Drug
Lamivudine (3TC)Drug
Stavudine (d4T)Drug
| Study group | Role | What they receive |
|---|---|---|
| Treatment of HIV- infected patients | Experimental | 14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine) Receives: Drug: Tipranavir (TPV); Drug: Ritonavir (RTV); Drug: Delavirdine (DLV); Drug: Zidovudine (ZDV); Drug: Lamivudine (3TC); Drug: Stavudine (d4T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment-emergent adverse events
Measured: Up to 46 weeks
Number of patients with drug-related adverse events
Measured: Up to 46 weeks
Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity
Measured: Up to 46 weeks
Number of patients with a treatment toxicity leading to study discontinuation
Measured: Up to 46 weeks
Number of patients with serious treatment-emergent adverse events
Measured: Up to 46 weeks
Number of patients with changes in laboratory parameters
Only lab values associated with metabolic disorders
Measured: Up to 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startMar 1999
- Primary completionApr 2000
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT02249130
- Sponsor's protocol ID
- 1182.3
- Status last verified
- Sep 2014
- First submitted
- 23 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tipranavir (PNU-140690): A Fourteen Day Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients. Report on the Post-study Option, a 46-week Treatment Period of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir
- ClinicalTrials.gov ID
- NCT02249130
- Acronym / sponsor ID
- 1182.3
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- Primary completion
- Apr 2000 (actual)
- First posted
- 25 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.
To investigate the safety of a standard triple therapy regimen of delavirdine (DLV), zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with regimens of tipranavir (TPV) with and without ritonavir (RTV)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of HIV- infected patients | Experimental | Drug: Tipranavir (TPV), Drug: Ritonavir (RTV), Drug: Delavirdine (DLV), Drug: Zidovudine (ZDV), Drug: Lamivudine (3TC), Drug: Stavudine (d4T)14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine) |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-1 RNA ≥ 5,000 copies/mL by Roche Amplicor assay
- CD4 cell count ≥ 50 cells/mm3
- Karnofsky performance status ≥ 80
- Age ≥ 13 years
- Screening laboratory values indicative of adequate baseline organ function, Grade 0 or 1 for laboratory values based on the ACTG toxicity scale grade. Selected stable [2 months or longer] Grade 2 laboratory abnormalities were subject to sponsor's approval
Key exclusion criteria (9 listed)
- Previous treatment with any antiretroviral drugs for more than 2 weeks
- Clinically significant, active and/or acute (onset within the prior month) medical problems including opportunistic infections, such as active cryptococcosis, Pneumocystis carinii pneumonia (PCP), herpes zoster, histoplasmosis or cytomegalovirus (CMV) , or non-opportunistic diseases including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
- History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair compliance with the study
- Receipt of any known enzyme-inducing drugs including rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfamidine, sulfinpyrazone, or troleandomycin within 30 days prior to participation in the study
- Receipt of any investigational medication within 30 days prior to participation in the study
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 (TPV) | Drug | Treatment of HIV- infected patients |
| Ritonavir (RTV) | Drug | Treatment of HIV- infected patients |
| Delavirdine (DLV) | Drug | Treatment of HIV- infected patients |
| Zidovudine (ZDV) | Drug | Treatment of HIV- infected patients |
| Lamivudine (3TC) | Drug | Treatment of HIV- infected patients |
| Stavudine (d4T) | Drug | Treatment of HIV- infected patients |
Primary outcome
Number of patients with treatment-emergent adverse events
Time frame: Up to 46 weeks
Number of patients with drug-related adverse events
Time frame: Up to 46 weeks
Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity
Time frame: Up to 46 weeks
Number of patients with a treatment toxicity leading to study discontinuation
Time frame: Up to 46 weeks
Number of patients with serious treatment-emergent adverse events
Time frame: Up to 46 weeks
Number of patients with changes in laboratory parameters
Time frame: Up to 46 weeks
Only lab values associated with metabolic disorders
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 25 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 (TPV), Ritonavir (RTV) and Delavirdine (DLV) 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 9 inclusion and 9 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 25 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?
Number of patients with treatment-emergent adverse events (time frame: Up to 46 weeks). 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 25 Sep 2014; AzTrials last refreshed its copy on 28 Oct 2026.