A Phase 3 interventional study of tipranavir and ritonavir in HIV Infections, sponsored by Boehringer Ingelheim. Terminated at 30 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-27.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The primary purpose of this study is to:
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 33 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Main inclusion criteria for the study are:
Exclusion Criteria:
Main exclusion criteria for the study are:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Drug: tipranavir · Drug: ritonavir · Drug: Optimized Background Regimen (OBR)
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Drug: tipranavir · Drug: ritonavir · Drug: Optimized Background Regimen (OBR)
Patients received between two and four active anti-retroviral medications based on resistance testing results, as background treatment, and remained on these for the duration of the trial.
Also known as: Nucleoside Reverse Transcriptase Inhibitors (NRTIs),, Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs),, Enfuvirtide,, Maraviroc,, Raltegravir
Treatment Response at Week 48
percentage of participants whose viral load \<50 copies/mL at Week 48
Time frame: after 48 weeks of treatment
Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48
Time frame: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48
Time frame: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Percentage of Participants Whose ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48
Time frame: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Change in Viral Load From Baseline at Each Visit
Time frame: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Time to Treatment Failure
For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL \>50 copies/mL at two consecutive measurements after having achieved a VL \<50 copies/mL.
Time frame: after Day 1 of treatment
Time to New AIDS or AIDS Related Progression Event or Death
Time frame: after Day 1 of treatment
Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48
Time frame: after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Change in Ratio of CD38+/CD8+ From Baseline to Week 48
Time frame: after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Time frame: after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Patients Adherence With Study Medication Based on Pill Count
Time frame: after 4 weeks of treatment
Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured
Time frame: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Occurrence of TPV Trough Concentration >120 μM
Time frame: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Post-dose TPV and RTV Concentrations at Week 4
Time frame: Week 4
| Milestone | Standard of Care (SoC) | Therapeutic Drug Monitoring (TDM) |
|---|---|---|
| Started | 15 | 18 |
| Completed | 3 | 3 |
| Not completed | 12 | 15 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Due to closure of trial | 8 | 10 |
| Withdrew: Other | 2 | 0 |
percentage of participants whose viral load \<50 copies/mL at Week 48
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL \>50 copies/mL at two consecutive measurements after having achieved a VL \<50 copies/mL.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 48 weeks of treatment plus 30 days follow-up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care (SoC) | — | 0/15 (0%) | 12/15 (80%) |
| Therapeutic Drug Monitoring (TDM) | — | 0/18 (0%) | 15/18 (83.3%) |
| Event | Standard of Care (SoC) | Therapeutic Drug Monitoring (TDM) |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 5/15 | 3/18 |
| VomitingGastrointestinal disorders | 1/15 | 4/18 |
| FatigueGeneral disorders | 3/15 | 0/18 |
| NauseaGastrointestinal disorders | 2/15 | 1/18 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 2/15 | 0/18 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 2/15 | 0/18 |
| RashSkin and subcutaneous tissue disorders | 2/15 | 1/18 |
| Blood triglycerides increasedInvestigations | 1/15 | 2/18 |
| DizzinessNervous system disorders | 0/15 | 2/18 |
| TinnitusEar and labyrinth disorders | 1/15 | 0/18 |
| Age, Continuous(years) | Standard of Care (SoC) | Therapeutic Drug Monitoring (TDM) | Total |
|---|---|---|---|
| Mean | 46.1 ± 8.2 | 43.2 ± 10.6 | 44.5 ± 9.6 |
| Sex: Female, Male(Participants) | Standard of Care (SoC) | Therapeutic Drug Monitoring (TDM) | Total |
|---|---|---|---|
| Female | 3 | 6 | 9 |
| Male | 12 | 12 | 24 |
The record gives a start of Feb 2007 and a primary completion of Oct 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2009, 1 year 1 month after primary completion.
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This study is terminated, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tipranavir