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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00076999 |
The primary objective of this study is to assess the safety and tolerability of tipranavir oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV SEDDS capsule formulation in adolescents switching from liquid to capsule.
The secondary objective of this study is the determination of the dose of TPV/r in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
Condition | Intervention | Phase |
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HIV Infections |
Drug: TPV/r |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | Multiple-Dose, Open-Label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-Dose Ritonavir in HIV-Infected Pediatric Patients |
Estimated Enrollment: | 115 |
Study Start Date: | November 2003 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A confirmed diagnosis of HIV-1 infection as defined by two positive assays from two different samples taken at least two weeks apart. The two results may be any combination of the following:
HIV RNA detected by RT-PCR or HIV proviral DNA detected by PCR HIV culture p24 antigen detection Licensed HIV ELISA with confirmatory Western blot
Acceptable screening laboratory values indicative of adequate baseline organ function. Laboratory values are considered acceptable if severity is no higher than Grade 1 for all tests defined by the DAIDS (> 3 months of age) Table for Grading Severity of Pediatric Adverse Experiences (Appendix 11.1) with the following exceptions:
Grade 2 GGT Grade 2 cholesterol (Appendix 11.2) Grade 2 triglycerides (Appendix 11.2)
Signed informed consent prior to study participation from the patient or a legal guardian.
Active assent must be given by the patient if the child and/or adolescent is capable of understanding the provided study information [this applies to children with the intellectual age of 7 years or greater]
Exclusion Criteria:
Female patients of childbearing potential who:
have a positive serum pregnancy test at screening are breast feeding are planning on becoming pregnant are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam)
Patients who are unwilling to abstain from ingesting contraindicated medications and substances which may significantly affect plasma levels of the study medications, notably:
Grapefruit juice or Seville oranges Herbal preparations containing St. John¿s Wort or milk thistle Garlic supplements
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1182.14 |
Study First Received: | February 9, 2004 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00076999 |
Health Authority: | United States: Food and Drug Administration; France: Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS); Italy: COMITATO ETICO PER LA SPERIMENTAZIONE DELL'AZ. OSP. DI PADOVA; Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS) |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Tipranavir |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |