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Home > "P" Clinical Trials Conditions > Pharmacokinetics and Safety Study of Tipranavir in Combination with Low Dose Ritonavir in HIV-Infected Children  Pharmacokinetics and Safety Study of Tipranavir in Combination with Low Dose Ritonavir in HIV-Infected Children
Pharmacokinetics and Safety Study of Tipranavir in Combination with Low Dose Ritonavir in HIV-Infected Children
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/18 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Texas Children's Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Childrens Hospital of Los Angeles *Recruiting*
Los Angeles, California, 90027
United States
Recruiting
UMASS Memorial Medical Center *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting
Baystate Medical Center *Recruiting*
Springfield, Massachusetts, 01199
United States
Recruiting
Rainbow Babies and Childrens Hospital *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting
Connecticut Children's Medical Center *Recruiting*
Hartford, Connecticut, 06106
United States
Recruiting
San Juan Hospital *Recruiting*
San Juan, , 00935
Puerto Rico
Recruiting
Los Angeles County - USC Medical Center *Recruiting*
Los Angeles, California, 90033
United States
Recruiting
Children's Memorial Hospital *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105
United States
Recruiting
Additional Information:
Study ID Numbers: BI 1182.14;
Study Start Date: February 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076999
Other Hiv Infections Studies:
1. A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children
2. A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated with Anti-HIV Drugs
3. A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
4. Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
5. Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Problems in HIV-Infected Patients with Increased CD4 Cells Counts Following Anti-HIV Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Pharmacokinetics and Safety Study of Tipranavir in Combination with Low Dose Ritonavir in HIV-Infected Children
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