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 Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00447902
First received: March 14, 2007
Last updated: May 18, 2012
Last verified: May 2012
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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 |
|---|
| No text entered. |
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 |
Outcome Measures
| 1. Primary: | Treatment Response at Week 48 [ Time Frame: 48 weeks ] |
| 2. 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 ] |
| 3. Secondary: | Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48 [ Time Frame: 24 and 48 weeks ] |
| 4. 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 ] |
| 5. 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 ] |
| 6. Secondary: | Change in Viral Load From Baseline at Each Visit [ Time Frame: After 4 weeks of treatment until the end of the trial ] |
| 7. Secondary: | Time to Treatment Failure [ Time Frame: After Day 1 of treatment until the end of the trial ] |
| 8. 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 ] |
| 9. Secondary: | Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ] |
| 10. Secondary: | Change in Ratio of CD38+/CD8+ From Baseline to Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ] |
| 11. 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 ] |
| 12. Secondary: | Patients Adherence With Study Medication Based on Pill Count [ Time Frame: After 4 weeks of treatment until the end of the trial ] |
| 13. 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 ] |
| 14. Secondary: | Occurrence of Tipranavir (TPV) Trough Concentration >120 μM [ Time Frame: After 2 weeks of treatment until the end of trial ] |
| 15. Secondary: | Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4 [ Time Frame: Week 4 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
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 |
Results Point of Contact:
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00447902 History of Changes |
| Other Study ID Numbers: | 1182.99, EudraCT No.: 2005-005023-33 |
| Study First Received: | March 14, 2007 |
| Results First Received: | September 25, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos Y Tecnología) Brazil: Agência Nacional de Vigilância Sanitária - ANVISA France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) Germany: Italy: Comitato Etico Locale per la Sperimentazione Clinica Osp. L. Sacco - Milano Portugal: INFARMED - Instituto Nacional da Farmácia e do Medicamento Parque da Saúde de Lisboa Av. do Brasil Lisboa Spain: United States: Food and Drug Administration |