Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation
This study has been terminated.
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00447902
First received: March 14, 2007
Last updated: April 25, 2014
Last verified: April 2014
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Results First Received: September 25, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment |
| Condition: |
HIV Infections |
| Interventions: |
Drug: tipranavir Drug: ritonavir |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| With FDA and EMEA agreement, the trial was prematurely discontinued before reaching the target number of patients to be entered due to poor recruitment. For this reason analyzing and reporting data as planned for primary and secondary endpoints have not been performed. No objectives were reached and no conclusion can be drawn from this study. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| One patient has been randomised by mistake in Brasil and so he was not treated |
Reporting Groups
| Description | |
|---|---|
| Standard of Care | Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules |
| Therapeutic Drug Monitoring | Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules |
Participant Flow: Overall Study
| Standard of Care | Therapeutic Drug Monitoring | |
|---|---|---|
| STARTED | 5 | 6 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 4 | 6 |
| Adverse Event | 0 | 3 |
| Protocol Violation | 1 | 0 |
| Withdrawal by Subject | 0 | 1 |
| included patients who discontinued | 1 | 1 |
| Lack of Efficacy | 2 | 1 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Standard of Care | Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules |
| Therapeutic Drug Monitoring | Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules |
| Total | Total of all reporting groups |
Baseline Measures
| Standard of Care | Therapeutic Drug Monitoring | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
4 | 6 | 10 |
|
Age
[units: years] Mean (Standard Deviation) |
46.00 (2.90) | 45.20 (5.40) | 45.50 (4.40) |
|
Gender
[1] [units: participants] |
|||
| Female | 1 | 1 | 2 |
| Male | 3 | 5 | 8 |
| [1] | Included patients who discontinued due to early termination |
|---|
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Treatment Response at Week 48 [ Time Frame: 48 weeks ] |
| 2. Primary: | The Primary Safety Endpoint Was the Occurrence of Dose-limiting Hepatotoxicity During the Study. [ Time Frame: From the start of the study through 48 weeks. ] |
| 3. Secondary: | Virologic Response Defined as Viral Load <50 Copies/mL at Each Visit [ Time Frame: After 4 weeks of treatment until the end of the trial ] |
| 4. Secondary: | Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48 [ Time Frame: 24 and 48 weeks ] |
| 5. Secondary: | Occurrence of Viral Load Less Than 400 Copies/mL at Each Visit [ Time Frame: After 4 weeks of treatment until the end of the trial ] |
| 6. Secondary: | Occurrence of ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48 [ Time Frame: Baseline, 24 and 48 weeks ] |
| 7. Secondary: | Change in Viral Load From Baseline at Each Visit [ Time Frame: After 4 weeks of treatment until the end of the trial ] |
| 8. Secondary: | Time to Treatment Failure [ Time Frame: After Day 1 of treatment until the end of the trial ] |
| 9. Secondary: | Time to New AIDS or AIDS Related Progression Event or Death [ Time Frame: After Day 1 of treatment until the end of the trial ] |
| 10. Secondary: | Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ] |
| 11. Secondary: | Change in Ratio of CD38+/CD8+ From Baseline to Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ] |
| 12. Secondary: | Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48. [ Time Frame: after 2 weeks of treatment till Week 48 ] |
Hide Outcome Measure 12
| Measure Type | Secondary |
|---|---|
| Measure Title | Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48. |
| Measure Description | Change from baseline to Week 48 for the ratio of CD3+ CD8+ CD38+ HLA DR . Samples were obtained for CD3+ CD8+ CD38+ HLA DR as measurements of viral suppression during antiretroviral therapy. |
| Time Frame | after 2 weeks of treatment till Week 48 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The trial has been stopped due to a poor enrollment |
Reporting Groups
| Description | |
|---|---|
| Standard of Care | Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules |
| Therapeutic Drug Monitoring | Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules |
Measured Values
| Standard of Care | Therapeutic Drug Monitoring | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
0 | 0 |
| Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48. |
No statistical analysis provided for Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.
| 13. Secondary: | 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 ] |
| 14. Secondary: | Patients Adherence With Study Medication Based on Pill Count [ Time Frame: After 4 weeks of treatment until the end of the trial ] |
| 15. Secondary: | Occurrence of Tipranavir (TPV) Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured [ Time Frame: After 2 weeks of treatment until the end of trial ] |
| 16. Secondary: | Occurrence of Tipranavir (TPV) Trough Concentration >120 μM [ Time Frame: After 2 weeks of treatment until the end of trial ] |
| 17. Secondary: | Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4 [ Time Frame: Week 4 ] |
| 18. Secondary: | Frequency of Patients (%) With Possible Clinically Significant Abnormalities of Laboratory Measurements [ Time Frame: Baseline through 48 weeks ] |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Due to an early termination of the trial no analysis has been performed for primary and secondary endpoints |