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Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in HIV-Infected Children
This study is ongoing, but not recruiting participants.
First Received: February 9, 2004   Last Updated: December 11, 2008   History of Changes
Sponsored by: 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

MedlinePlus related topics: AIDS
Drug Information available for: Ritonavir Tipranavir
U.S. FDA Resources
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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint for this study is the assessment of safety and tolerability of TPV oral formulation using adverse events and significant changes in baseline laboratory measurements [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • 1. TPV and RTV PK parameters and relative bioavailability of TPV liquid formulation and TPV capsules 2. Proportion of patients with a viral load < 400 copies/mL 3. Change in CD4 count 4. Compliance with medication 5. Time to treatment failure [ Time Frame: 24, 48 weeks ]

Estimated Enrollment: 115
Study Start Date: November 2003
Estimated Primary Completion Date: December 2009 (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
Criteria

Inclusion Criteria:

  1. Males and females between 2 and 18 years of age.
  2. 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
  3. Viral load > 1500 RNA copies/mL.
  4. 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)
  5. 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]

  6. In the opinion of the investigator, an ability to take medications and comply with the requirements of the protocol.

Exclusion Criteria:

  1. 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)

  2. Active hepatitis B or C disease defined as HBsAg positivity or HCV antibody or RNA positivity with AST/ALT > Grade 2.
  3. Life expectancy < 12 months.
  4. 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
  5. Active substance abuse.
  6. Use of investigational medications or vaccines within 28 days before study entry or during the trial. Some expanded access antiretroviral medications may be acceptable, but must be approved by BI.
  7. Requirement for any therapy for malignancy or immunomodulatory drug (e.g. interferon, cyclosporine, hydroxyurea, interleukin-2) within 28 days of study entry. Replacement intravenous gamma globulin treatment is acceptable.
  8. Any active opportunistic infection within 28 days before study entry or other clinically significant findings that may compromise the outcome of the study.
  9. Patients with malabsorption, severe chronic diarrhea or vomiting (more than two episodes of moderate or severe intensity, not attributed to medication therapy and lasting more than four days) within 28 days of the study.
  10. Evidence or symptoms of encephalopathy or developmental delay that would reduce compliance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076999

  Show 32 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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     History of Changes
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)

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Tipranavir

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009