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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00076999 |
Purpose
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) 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 capsule formulation in adolescents switching from liquid to capsule.
The secondary objective of this study is the determination of the dose of topranavir and ritonavir (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 |
|---|---|---|
|
HIV Infections |
Drug: TPV oral solution Drug: RTV oral solution |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients |
| Enrollment: | 115 |
| Study Start Date: | November 2003 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TPV/r 290/115 mg/m^2
TPV and RTV oral solution low dose
|
Drug: TPV oral solution
Tipranavir oral solution
Drug: RTV oral solution
Ritonavir oral solution
|
|
Experimental: TPV/r 375/150 mg/m^2
TPV and RTV oral solution high dose
|
Drug: TPV oral solution
Tipranavir oral solution
Drug: RTV oral solution
Ritonavir oral solution
|
Eligibility| 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 ribonucleic acid (RNA) detected by reverse transcriptase (RT)-polymerase chain reaction(PCR) or HIV proviral deoxyribonucleic acid (DNA) detected by PCR HIV culture p24 antigen detection Licensed HIV enzyme-linked immunosorbent assay (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 Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Pediatric Adverse Experiences (> 3 months of age) with the following exceptions:
Grade 2 gamma-glutamyl transferase Grade 2 cholesterol Grade 2 triglycerides
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
Contacts and Locations
Show 30 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| 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 |
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir |
Tipranavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |