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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 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 |
|---|---|---|
|
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: | March 2010 (Final data collection date for primary outcome measure) |
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 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
Contacts and Locations
Hide Study Locations| United States, California | |
| 1182.14.00001 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1182.14.00006 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| United States, Connecticut | |
| 1182.14.00010 Boehringer Ingelheim Investigational Site | |
| Hartford, Connecticut, United States | |
| United States, Illinois | |
| 1182.14.00004 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| 1182.14.00008 Boehringer Ingelheim Investigational Site | |
| North Worcester, Massachusetts, United States | |
| 1182.14.00009 Boehringer Ingelheim Investigational Site | |
| Springfield, Massachusetts, United States | |
| United States, Ohio | |
| 1182.14.00002 Boehringer Ingelheim Investigational Site | |
| Cleveland, Ohio, United States | |
| United States, Tennessee | |
| 1182.14.00007 Boehringer Ingelheim Investigational Site | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| 1182.14.00003 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| Argentina | |
| 1182.14.5401 Fundación Huésped | |
| Capital Federal, Argentina | |
| Brazil | |
| 1182.14.55004 R. Pedro de Toledo, 1800 - 15º. Andar | |
| Vila Clementino São Paulo, Brazil | |
| 1182.14.55001 | |
| Belo Horizonte, Brazil | |
| 1182.14.55002 | |
| São Paulo, Brazil | |
| 1182.14.55003 | |
| São Paulo, Brazil | |
| Canada, Ontario | |
| 1182.14.11002 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| 1182.14.11001 Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| France | |
| 1182.14.33001 Boehringer Ingelheim Investigational Site | |
| Paris Cedex 15, France | |
| 1182.14.33002 Boehringer Ingelheim Investigational Site | |
| Paris, France | |
| 1182.14.33003 Boehringer Ingelheim Investigational Site | |
| Paris Cedex 14, France | |
| 1182.14.33004 Boehringer Ingelheim Investigational Site | |
| Lyon Cedex 3, France | |
| 1182.14.33005 Boehringer Ingelheim Investigational Site | |
| Nantes Cedex 1, France | |
| 1182.14.33006 Boehringer Ingelheim Investigational Site | |
| Paris Cedex 12, France | |
| Germany | |
| 1182.14.49001 Boehringer Ingelheim Investigational Site | |
| Frankfurt/Main, Germany | |
| 1182.14.49002 Boehringer Ingelheim Investigational Site | |
| Berlin, Germany | |
| 1182.14.49004 Boehringer Ingelheim Investigational Site | |
| München, Germany | |
| Italy | |
| 1182.14.39001 Boehringer Ingelheim Investigational Site | |
| Padova, Italy | |
| 1182.14.39003 Boehringer Ingelheim Investigational Site | |
| Roma, Italy | |
| Mexico | |
| 1182.14.52001 CLINDI (Clínica de Inmunodeficiencias) | |
| México, D.f., Mexico | |
| 1182.14.52002 | |
| México, D.f., Mexico | |
| Puerto Rico | |
| 1182.14.00005 Boehringer Ingelheim Investigational Site | |
| San Juan, Puerto Rico | |
| Spain | |
| 1182.14.34001 Boehringer Ingelheim Investigational Site | |
| Madrid, Spain | |
| 1182.14.34002 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1182.14 |
| Study First Received: | February 9, 2004 |
| Last Updated: | November 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00076999 History of Changes |
| 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 |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Tipranavir Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |