- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00076999
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
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.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Berlin, 독일
- 1182.14.49002 Boehringer Ingelheim Investigational Site
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Frankfurt/Main, 독일
- 1182.14.49001 Boehringer Ingelheim Investigational Site
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München, 독일
- 1182.14.49004 Boehringer Ingelheim Investigational Site
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México, D.F., 멕시코
- 1182.14.52001 CLINDI (Clínica de Inmunodeficiencias)
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México, D.F., 멕시코
- 1182.14.52002
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California
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Los Angeles, California, 미국
- 1182.14.00001 Boehringer Ingelheim Investigational Site
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Los Angeles, California, 미국
- 1182.14.00006 Boehringer Ingelheim Investigational Site
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Connecticut
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Hartford, Connecticut, 미국
- 1182.14.00010 Boehringer Ingelheim Investigational Site
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Illinois
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Chicago, Illinois, 미국
- 1182.14.00004 Boehringer Ingelheim Investigational Site
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Massachusetts
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North Worcester, Massachusetts, 미국
- 1182.14.00008 Boehringer Ingelheim Investigational Site
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Springfield, Massachusetts, 미국
- 1182.14.00009 Boehringer Ingelheim Investigational Site
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Ohio
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Cleveland, Ohio, 미국
- 1182.14.00002 Boehringer Ingelheim Investigational Site
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Tennessee
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Memphis, Tennessee, 미국
- 1182.14.00007 Boehringer Ingelheim Investigational Site
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Texas
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Houston, Texas, 미국
- 1182.14.00003 Boehringer Ingelheim Investigational Site
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São Paulo, 브라질
- 1182.14.55002
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São Paulo, 브라질
- 1182.14.55003
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Barcelona, 스페인
- 1182.14.34002 Boehringer Ingelheim Investigational Site
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Madrid, 스페인
- 1182.14.34001 Boehringer Ingelheim Investigational Site
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Capital Federal, 아르헨티나
- 1182.14.5401 Fundación Huésped
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Padova, 이탈리아
- 1182.14.39001 Boehringer Ingelheim Investigational Site
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Roma, 이탈리아
- 1182.14.39003 Boehringer Ingelheim Investigational Site
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Ontario
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Toronto, Ontario, 캐나다
- 1182.14.11002 Boehringer Ingelheim Investigational Site
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Quebec
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Montreal, Quebec, 캐나다
- 1182.14.11001 Boehringer Ingelheim Investigational Site
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San Juan, 푸에르토 리코
- 1182.14.00005 Boehringer Ingelheim Investigational Site
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Lyon cedex 3, 프랑스
- 1182.14.33004 Boehringer Ingelheim Investigational Site
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Nantes cedex 1, 프랑스
- 1182.14.33005 Boehringer Ingelheim Investigational Site
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Paris, 프랑스
- 1182.14.33002 Boehringer Ingelheim Investigational Site
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Paris cedex 12, 프랑스
- 1182.14.33006 Boehringer Ingelheim Investigational Site
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Paris cedex 14, 프랑스
- 1182.14.33003 Boehringer Ingelheim Investigational Site
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Paris cedex 15, 프랑스
- 1182.14.33001 Boehringer Ingelheim Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Males and females between 2 and 18 years of age.
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
- Viral load > 1500 RNA copies/mL.
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)
- In the opinion of the investigator, an ability to take medications and comply with the 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 to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam)
- Active hepatitis B or C disease defined as hepatitis B surface antigen (HBsAg) positivity or hepatitis C (HCV) antibody or RNA positivity with aspartate aminotransferase(AST)/ alanine aminotransferase(ALT) > Grade 2.
- 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, notably:
Grapefruit juice or Seville oranges Herbal preparations containing St. John's Wort or milk thistle Garlic supplements
- Active substance abuse.
- 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 sponsor.
- 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.
- 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 (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.
- Evidence or symptoms of encephalopathy or developmental delay that would reduce compliance.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: TPV/r 290/115 mg/m^2
TPV and RTV oral solution low dose
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Tipranavir oral solution
Ritonavir oral solution
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실험적: TPV/r 375/150 mg/m^2
TPV and RTV oral solution high dose
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Tipranavir oral solution
Ritonavir oral solution
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
기간: up to 288 weeks
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Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health).
DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
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up to 288 weeks
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Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
기간: up to 288 weeks
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Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health).
DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
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up to 288 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
기간: baseline, week 24
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baseline, week 24
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Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
기간: baseline, week 48
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baseline, week 48
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Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)
기간: baseline, week 100
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baseline, week 100
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Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
기간: baseline, week 24
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baseline, week 24
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Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
기간: baseline, week 48
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baseline, week 48
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Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
기간: baseline, week 100
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baseline, week 100
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Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
기간: baseline, week 24
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baseline, week 24
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Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
기간: baseline, week 48
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baseline, week 48
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Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
기간: baseline, week 100
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baseline, week 100
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Baseline Median Viral Load log10 Copies/mL
기간: baseline
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baseline
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Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)
기간: baseline, week 24
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baseline, week 24
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Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)
기간: baseline, week 48
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baseline, week 48
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Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)
기간: baseline, week 100
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baseline, week 100
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Baseline Median CD4+ Cell Count (Cells/mm3)
기간: baseline
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baseline
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Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)
기간: baseline, week 24
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baseline, week 24
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Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)
기간: baseline, week 48
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baseline, week 48
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Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)
기간: baseline, week 100
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baseline, week 100
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Median Baseline CD4 Percent
기간: baseline
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Percentage of lymphocytes that are CD4 cells
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baseline
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Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)
기간: baseline, week 24
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Percentage of lymphocytes that are CD4 cells
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baseline, week 24
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Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)
기간: baseline, week 48
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Percentage of lymphocytes that are CD4 cells
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baseline, week 48
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Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)
기간: baseline, week 100
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Percentage of lymphocytes that are CD4 cells
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baseline, week 100
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Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8
기간: week 8
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week 8
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Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
기간: week 16
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week 16
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Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
기간: week 24
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week 24
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Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
기간: week 48
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week 48
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Salazar JC, Cahn P, Della Negra M, De Aquino MZ, Robinson PA, Jelaska A, Mikl J. Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience. Pediatr Infect Dis J. 2014 Apr;33(4):396-400. doi: 10.1097/INF.0000000000000038.
- Salazar JC, Cahn P, Yogev R, Negra MD, Castelli-Gattinara G, Fortuny C, Flynn PM, Giaquinto C, Ruan PK, Smith ME, Mikl J, Jelaska A; PACTG 1051/BI Study Team. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008 Sep 12;22(14):1789-98. doi: 10.1097/QAD.0b013e32830c481b.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
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National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
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Erasmus Medical Center모병
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Erasmus Medical Center모집하지 않고 적극적으로
TPV oral solution에 대한 임상 시험
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Taewoong Medical Co., Ltd.Avania모집하지 않고 적극적으로
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Boehringer Ingelheim완전한
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Boehringer Ingelheim완전한
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Seoul National University Hospital완전한심혈관 이상 | 폐 판막 부전 | 폐동맥 판막 협착증 | 선천성 심장 결함대한민국
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Boehringer Ingelheim완전한
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Federal University of the Valleys of Jequitinhonha...완전한
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Boehringer Ingelheim완전한