Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation

This study has been terminated.

Sponsor:

Information provided by:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00447902

First received: March 14, 2007

Last updated: April 25, 2014

Last verified: April 2014

History of Changes

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

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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

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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

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1. Primary:

Treatment Response at Week 48 [ Time Frame: 48 weeks ]

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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. ]

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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 ]

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4. Secondary:

Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48 [ Time Frame: 24 and 48 weeks ]

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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 ]

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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 ]

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7. Secondary:

Change in Viral Load From Baseline at Each Visit [ Time Frame: After 4 weeks of treatment until the end of the trial ]

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8. Secondary:

Time to Treatment Failure [ Time Frame: After Day 1 of treatment until the end of the trial ]

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Measure Type	Secondary
Measure Title	Time to Treatment Failure
Measure Description	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 until the end of the trial
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
Time to Treatment Failure

No statistical analysis provided for Time to Treatment Failure

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 ]

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10. Secondary:

Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ]

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11. Secondary:

Change in Ratio of CD38+/CD8+ From Baseline to Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ]

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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 ]

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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 ]

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14. Secondary:

Patients Adherence With Study Medication Based on Pill Count [ Time Frame: After 4 weeks of treatment until the end of the trial ]

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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 ]

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16. Secondary:

Occurrence of Tipranavir (TPV) Trough Concentration >120 μM [ Time Frame: After 2 weeks of treatment until the end of trial ]

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17. Secondary:

Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4 [ Time Frame: Week 4 ]

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18. Secondary:

Frequency of Patients (%) With Possible Clinically Significant Abnormalities of Laboratory Measurements [ Time Frame: Baseline through 48 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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

More Information

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Certain Agreements:

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:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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

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:	April 25, 2014
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

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