Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00530920

First received: September 17, 2007

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: May 15, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: tipranavir Drug: ritonavir

Participant Flow

Hide 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
No text entered.

Reporting Groups

	Description
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily	No text entered.
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily	No text entered.
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily	No text entered.

Participant Flow: Overall Study

	Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily	Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily	Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
STARTED	30	27	28
COMPLETED	30	25	24
NOT COMPLETED	0	2	4
Adverse Event	0	0	3
Withdrawal by Subject	0	2	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily	No text entered.
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily	No text entered.
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily	Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily	Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily	Total
Number of Participants [units: participants]	30	27	28	85
Age [units: years] Mean ± Standard Deviation	33 ± 7.54	36.9 ± 8.04	36.4 ± 8	35.3 ± 7.94
Gender [units: participants]
Female	2	1	4	7
Male	28	26	24	78

Outcome Measures

Show All Outcome Measures

1. Primary:

Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID) [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

Show Outcome Measure 1

2. Primary:

Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

Show Outcome Measure 2

3. Primary:

Trough Concentration (Cmin) of Tipranavir [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

Show Outcome Measure 3

4. Primary:

Maximum Concentration (Cmax) of Tipranavir [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

Show Outcome Measure 4

5. Primary:

Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF)) [ Time Frame: Baseline (Day 0) to Final (Day 14) ]

Show Outcome Measure 5

6. Secondary:

Apparent Oral Clearance I(Cl/F) of Tipranavir [ Time Frame: Final (Day 14) ]

Show Outcome Measure 6

7. Secondary:

Volume of Distribution (V/F) of Tipranavir [ Time Frame: Final (Day 14) ]

Show Outcome Measure 7

8. Secondary:

Terminal Half-Life (t1/2) of Tipranavir [ Time Frame: Final (Day 14) ]

Show Outcome Measure 8

9. Secondary:

Time to Cmax (Tmax) of Tipranavir [ Time Frame: Final (Day 14) ]

Show Outcome Measure 9

10. Secondary:

AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

Show Outcome Measure 10

11. Secondary:

Cp 24 h of Ritonavirfor QD and CP 12 h of Ritonavir for BID [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

Show Outcome Measure 11

12. Secondary:

Apparent Oral Clearance I(Cl/F) of Ritonavir [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

Show Outcome Measure 12

13. Secondary:

Volume of Distribution (V/F) of Ritonavir [ Time Frame: Final (Day 14) ]

Hide Outcome Measure 13

Measure Type	Secondary
Measure Title	Volume of Distribution (V/F) of Ritonavir
Measure Description	Ritonavir pharmacokinetics
Time Frame	Final (Day 14)
Safety Issue

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
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily	No text entered.
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily	No text entered.
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily	No text entered.

Measured Values

	Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily	Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily	Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Number of Participants Analyzed [units: participants]	30	25	24
Volume of Distribution (V/F) of Ritonavir [units: L] Geometric Mean ± Standard Deviation	97.5 ± 26.13	90.8 ± 22.43	88.9 ± 25.51

No statistical analysis provided for Volume of Distribution (V/F) of Ritonavir

14. Secondary:

Terminal Half-Life (t1/2) of Ritonavir [ Time Frame: Final (Day 14) ]

Show Outcome Measure 14

15. Secondary:

Tmax of Ritonavir [ Time Frame: Final (Day 14) ]

Show Outcome Measure 15

16. Secondary:

Cmax of Ritonavir [ Time Frame: Visits baseline, 5, 7, 9 and 13 or 14 ]

Show Outcome Measure 16

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

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
No text entered.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Pharmaceuticals
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:	NCT00530920 History of Changes
Other Study ID Numbers:	1182.107
Study First Received:	September 17, 2007
Results First Received:	May 15, 2009
Last Updated:	May 18, 2012
Health Authority:	Italy: Comitato Etico Per La Sperimentazione Clinica Dei Medicinali Az. San. - Firenze

To Top