Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00076999
First received: February 9, 2004
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: June 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: TPV oral solution
Drug: RTV oral solution

  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
TPV OS 2-<6 Yrs Tipranavir Oral Solution (TPV OS), ages 2-5
TPV OS 6-<12 Yrs Tipranavir Oral Solution (TPV OS), ages 6-11
TPV OS 12-18 Yrs Tipranavir Oral Solution (TPV OS), ages 12-18
TPV SEDDS 6-<12 Yrs TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
TPV SEDDS 12-18 Yrs TPV self-emulsifying drug delivery system (SEDDS), ages 12-18

Participant Flow:   Overall Study
    TPV OS 2-<6 Yrs     TPV OS 6-<12 Yrs     TPV OS 12-18 Yrs     TPV SEDDS 6-<12 Yrs     TPV SEDDS 12-18 Yrs  
STARTED     25     31     19     6     34  
COMPLETED     13     7     2     5     9  
NOT COMPLETED     12     24     17     1     25  
Adverse Event                 2                 8                 6                 0                 2  
Protocol Violation                 0                 3                 4                 0                 9  
Lost to Follow-up                 2                 1                 0                 0                 0  
Withdrawal by Subject                 0                 4                 3                 0                 1  
Other reason (not specified)                 8                 8                 4                 1                 13  



  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
TPV OS 2-<6 Yrs Patients treated with Tipranavir Oral Solution, ages 2-5
TPV OS 6-<12 Yrs Patients treated with Tipranavir Oral Solution, ages 6-11
TPV OS 12-18 Yrs Patients treated with Tipranavir Oral Solution, ages 12-18
TPV SEDDS 12-18 Yrs Patients treated with Tipranavir SEDDS, ages 12-18
Total Total of all reporting groups

Baseline Measures
    TPV OS 2-<6 Yrs     TPV OS 6-<12 Yrs     TPV OS 12-18 Yrs     TPV SEDDS 12-18 Yrs     Total  
Number of Participants  
[units: participants]
  25     37     24     29     115  
Age  
[units: years]
Mean ± Standard Deviation
  4.1  ± 1.1     9.5  ± 1.4     14.4  ± 1.7     15.1  ± 1.7     10.8  ± 4.5  
Gender  
[units: participants]
         
Female     10     15     10     15     50  
Male     15     22     14     14     65  
Race/Ethnicity, Customized  
[units: participants]
         
Hispanic / Latino     22     20     11     8     61  
Mixed Race     1     0     2     2     5  
Unknown     2     17     11     19     49  
Race/Ethnicity, Customized  
[units: participants]
         
White     18     26     16     20     80  
Black     6     10     8     9     33  
Asian     1     1     0     0     2  
Region of Enrollment  
[units: participants]
         
North America     3     14     13     11     41  
South America and Mexico     22     14     4     5     45  
Europe     0     9     7     13     29  
Antiretroviral Experienced  
[units: participants]
         
Yes     24     36     24     28     112  
No     1     1     0     1     3  



  Outcome Measures
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1.  Primary:   Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation   [ Time Frame: up to 288 weeks ]

2.  Primary:   Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation   [ Time Frame: up to 288 weeks ]

3.  Secondary:   Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)   [ Time Frame: baseline, week 24 ]

4.  Secondary:   Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)   [ Time Frame: baseline, week 48 ]

5.  Secondary:   Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)   [ Time Frame: baseline, week 100 ]

6.  Secondary:   Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)   [ Time Frame: baseline, week 24 ]

7.  Secondary:   Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)   [ Time Frame: baseline, week 48 ]

8.  Secondary:   Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)   [ Time Frame: baseline, week 100 ]

9.  Secondary:   Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)   [ Time Frame: baseline, week 24 ]

10.  Secondary:   Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)   [ Time Frame: baseline, week 48 ]

11.  Secondary:   Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)   [ Time Frame: baseline, week 100 ]

12.  Secondary:   Baseline Median Viral Load log10 Copies/mL   [ Time Frame: baseline ]

13.  Secondary:   Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)   [ Time Frame: baseline, week 24 ]

14.  Secondary:   Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)   [ Time Frame: baseline, week 48 ]

15.  Secondary:   Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)   [ Time Frame: baseline, week 100 ]

16.  Secondary:   Baseline Median CD4+ Cell Count (Cells/mm3)   [ Time Frame: baseline ]

17.  Secondary:   Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)   [ Time Frame: baseline, week 24 ]

18.  Secondary:   Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)   [ Time Frame: baseline, week 48 ]

19.  Secondary:   Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)   [ Time Frame: baseline, week 100 ]

20.  Secondary:   Median Baseline CD4 Percent   [ Time Frame: baseline ]

21.  Secondary:   Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)   [ Time Frame: baseline, week 24 ]

22.  Secondary:   Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)   [ Time Frame: baseline, week 48 ]

23.  Secondary:   Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)   [ Time Frame: baseline, week 100 ]

24.  Secondary:   Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8   [ Time Frame: week 8 ]

25.  Secondary:   Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16   [ Time Frame: week 16 ]

26.  Secondary:   Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24   [ Time Frame: week 24 ]

27.  Secondary:   Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48   [ Time Frame: week 48 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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 Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00076999     History of Changes
Other Study ID Numbers: 1182.14
Study First Received: February 9, 2004
Results First Received: June 27, 2011
Last Updated: February 24, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Brazil: Ministry of Health
Canada: Health Canada
France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)
Germany: Federal Institute for Drugs and Medical Devices
Italy: COMITATO ETICO PER LA SPERIMENTAZIONE DELL'AZ. OSP. DI PADOVA
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration