SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00440271
First received: February 26, 2007
Last updated: June 17, 2014
Last verified: January 2014
Results First Received: October 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: tipranavir
Drug: ritonavir
Drug: Optimized Background Regimen (OBR)

  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
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
Standard of Care (SoC) 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.
Therapeutic Drug Monitoring (TDM) 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.

Participant Flow:   Overall Study
    Standard of Care (SoC)     Therapeutic Drug Monitoring (TDM)  
STARTED     15     18  
COMPLETED     3     3  
NOT COMPLETED     12     15  
Protocol Violation                 1                 1  
Adverse Event                 0                 1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 0                 2  
Lack of Efficacy                 0                 1  
Due to closure of trial                 8                 10  
Unknown                 2                 0  



  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 (SoC) 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.
Therapeutic Drug Monitoring (TDM) 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.
Total Total of all reporting groups

Baseline Measures
    Standard of Care (SoC)     Therapeutic Drug Monitoring (TDM)     Total  
Number of Participants  
[units: participants]
  15     18     33  
Age  
[units: years]
Mean ± Standard Deviation
  46.1  ± 8.2     43.2  ± 10.6     44.5  ± 9.6  
Gender  
[units: participants]
     
Female     3     6     9  
Male     12     12     24  



  Outcome Measures
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1.  Primary:   Treatment Response at Week 48   [ Time Frame: after 48 weeks of treatment ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   Time to Treatment Failure   [ Time Frame: after Day 1 of treatment ]

7.  Secondary:   Time to New AIDS or AIDS Related Progression Event or Death   [ Time Frame: after Day 1 of treatment ]

8.  Secondary:   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) ]

9.  Secondary:   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) ]

10.  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 (Weeks 2, 4, 8, 12, 24, 36, and 48) ]

11.  Secondary:   Patients Adherence With Study Medication Based on Pill Count   [ Time Frame: after 4 weeks of treatment ]

12.  Secondary:   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) ]

13.  Secondary:   Occurrence of TPV Trough Concentration >120 μM   [ Time Frame: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48) ]

14.  Secondary:   Post-dose TPV and RTV Concentrations at Week 4   [ Time Frame: Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  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
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the 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:
unchecked 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.
unchecked 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.


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
ClinicalTrials.gov Identifier: NCT00440271     History of Changes
Other Study ID Numbers: 1182.98, EudraCT No.: 2005-005264-86
Study First Received: February 26, 2007
Results First Received: October 20, 2009
Last Updated: June 17, 2014
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos Y Tecnología)
Brazil: ANVISA
Canada: Therapeutic Products Directorate
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Italy: Comitato Etico della Fondazione Centro S. Raffaele del Monte Tabor (IRCCS) - Milano
Spain:
United States: Food and Drug Administration