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

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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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

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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

Median Baseline CD4 Percent [ Time Frame: baseline ]

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21. Secondary:

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

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

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

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25. Secondary:

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

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26. Secondary:

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

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27. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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.

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
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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 Pharmaceuticals

Publications automatically indexed to this study:

Salazar JC, Cahn P, Yogev R, Negra MD, Castelli-Gattinara G, Fortuny C, Flynn PM, Giaquinto C, Ruan PK, Smith ME, Mikl J, Jelaska A; PACTG 1051/BI Study Team. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008 Sep 12;22(14):1789-98.

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:	August 18, 2011
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