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Tipranavir in Combination With Ritonavir in HIV-Infected Children

This study is ongoing, but not recruiting participants.

Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00076999
  Purpose

The purpose of this study is to determine the safety and tolerability of liquid formulation tipranavir together with low dose ritonavir in HIV-infected children and adolescents. Additionally, the study will provide information concerning the pharmacologic characteristics of tipranavir in this age group.


Condition Intervention Phase
HIV Infections
Drug: Tipranavir
Drug: Ritonavir
Phase I
Phase II

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Ritonavir    Tipranavir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:   Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in HIV-Infected Children

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment:   100
Study Start Date:   February 2004
Estimated Study Completion Date:   June 2007

  Eligibility
Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

INCLUSION CRITERIA

  • Males and females between 2 and 18 years of age
  • Confirmed diagnosis of HIV-1 infection
  • Viral load > 1500 RNA copies/mL
  • Acceptable screening laboratory values indicative of adequate baseline organ function
  • Signed informed consent prior to study participation from the patient or legal guardian
  • Ability to take medications and comply with requirements of the protocol

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
  • Active hepatitis B or C disease
  • Life expectancy <12 months
  • Patients who are unwilling to abstain from ingesting contraindicated medications and substances which may significantly affect plasma levels of the study medications
  • Active substance abuse
  • Use of investigational medications or vaccines within 28 days before study entry or during the trial
  • Requirement for any therapy for malignancy or immunomodulatory drug
  • Any active opportunistic infection within 28 days before study entry or other clinically significant findings that may compromise the outcome of the study
  • Patients with malabsorption, severe chronic diarrhea or vomiting
  • Evidence of symptoms of encephalopathy or developmental delay that would reduce compliance
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076999

Locations
United States, California
Childrens Hospital of Los Angeles    
      Los Angeles, California, United States, 90027
Los Angeles County - USC Medical Center    
      Los Angeles, California, United States, 90033
United States, Connecticut
Connecticut Children's Medical Center    
      Hartford, Connecticut, United States, 06106
United States, Illinois
Children's Memorial Hospital    
      Chicago, Illinois, United States, 60614
United States, Massachusetts
UMASS Memorial Medical Center    
      Worcester, Massachusetts, United States, 01655
Baystate Medical Center    
      Springfield, Massachusetts, United States, 01199
United States, Ohio
Rainbow Babies and Childrens Hospital    
      Cleveland, Ohio, United States, 44106
United States, Tennessee
St. Jude Children's Research Hospital    
      Memphis, Tennessee, United States, 38105
United States, Texas
Texas Children's Hospital    
      Houston, Texas, United States, 77030
Puerto Rico
San Juan Hospital    
      San Juan, Puerto Rico, 00935

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
  More Information

Study ID Numbers:   1182.14
First Received:   February 9, 2004
Last Updated:   July 2, 2007
ClinicalTrials.gov Identifier:   NCT00076999
Health Authority:   United States: Food and Drug Administration

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:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on August 21, 2008




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