- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00012519
Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment
A Phase I/II Trial of Ritonavir and Indinavir in Children Failing Other Antiretroviral Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Combination regimens of RTV and IDV in adults offer the benefit of two potent antiretroviral agents, convenience of twice-daily dosing, unrestricted timing of meals, and fewer renal complications. There are limited, largely anecdotal data from children suggesting that initial virologic response can also be attained in children given IDV with RTV, but there are not sufficient pharmacokinetic data to define appropriate dose regimens. This study will evaluate the clinical feasibility of a combination RTV and IDV regimen for children.
Patients will be stratified on the basis of age/Tanner stage and ability to swallow intact capsules. Patients will be randomized to either Balanced Dose or Low Dose RTV treatment arms. Patients in the Balanced Dose Arm will receive RTV and IDV in approximately equal doses. The Low Dose RTV Arm will receive a dosing ratio of RTV:IDV of approximately 1:3. Patients will have scheduled study visits every 4 weeks for 6 months, then every 3 months for approximately 18 months. Study visits will consist of a medical history, physical exam, and blood and urine tests. Patients will have intensive pharmacokinetic analysis at Week 4 (or 2 weeks after a stable dose of study drugs has been reached) and Week 16. Study visits that include pharmacokinetic analysis will last 9 to 13 hours.
At each study visit, patients will be closely assessed for drug toxicity and virologic response. At the end of the study, patients with good virologic response and no evidence of toxicity may choose to enter a 48 week extension phase and continue taking the combination regimen.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 009367344
- San Juan City Hosp. PR NICHD CRS
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District of Columbia
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Washington, District of Columbia, United States, 20060
- Howard Univ. Washington DC NICHD CRS
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Florida
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Gainesville, Florida, United States, 32610
- Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
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Jacksonville, Florida, United States, 32209
- Univ. of Florida Jacksonville NICHD CRS
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Illinois
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Chicago, Illinois, United States, 606143394
- Chicago Children's CRS
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New York
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New York, New York, United States, 10032
- Columbia IMPAACT CRS
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New York, New York, United States, 10037
- Harlem Hosp. Ctr. NY NICHD CRS
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New York, New York, United States, 10029
- Metropolitan Hosp. Ctr.
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Syracuse, New York, United States, 13210
- SUNY Upstate Med. Univ., Dept. of Peds.
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Tennessee
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Memphis, Tennessee, United States, 381052794
- St. Jude/UTHSC CRS
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hosp. CRS
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Virginia
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Richmond, Virginia, United States, 23219
- VCU Health Systems, Dept. of Peds
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- HIV infection
- HIV RNA levels > 10,000 copies/ml within 30 days prior to study entry
- Anti-HIV drug therapy failure while on the same anti-HIV drugs for more than 16 weeks
- Body size above a certain limit (body surface area > 0.48 m2)
- Acceptable methods of contraception
- Consent of parent or legal guardian
Exclusion Criteria
- Unable to determine HIV genotypic resistance
- HIV resistant to IDV or RTV at study screening
- Previously received IDV and RTV at the same time
- Need treatment with any medication prohibited by the study
- Glucocorticoids for more than 14 days at study entry
- Cancer requiring chemotherapy
- Drugs affecting the immune system, other than IVIG, within 3 months of study entry
- Certain abnormal laboratory results at study entry
- Pregnant or breast-feeding
- Unable to be followed at a PACTG center during the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Ram Yogev
- Study Chair: Ellen Chadwick
- Study Chair: Stephen Pelton
- Study Chair: Elaine Abrams
Publications and helpful links
General Publications
- Saah AJ, Winchell GA, Nessly ML, Seniuk MA, Rhodes RR, Deutsch PJ. Pharmacokinetic profile and tolerability of indinavir-ritonavir combinations in healthy volunteers. Antimicrob Agents Chemother. 2001 Oct;45(10):2710-5. doi: 10.1128/AAC.45.10.2710-2715.2001.
- van Rossum AM, de Groot R, Hartwig NG, Weemaes CM, Head S, Burger DM. Pharmacokinetics of indinavir and low-dose ritonavir in children with HIV-1 infection. AIDS. 2000 Sep 29;14(14):2209-10. doi: 10.1097/00002030-200009290-00022. No abstract available.
- Chadwick EG, Rodman JH, Samson P, Fenton T, Abrams EJ, Nowak B, Pelton SI, Lavoie S, Knapp K, Bambji M, Yogev R, PACTG 1013 Team. Antiviral Activity, Tolerance and Pharmacokinetics of Indinavir with Two Doses of Ritonavir as Salvage Therapy in Children. 10th Conference on Retroviruses and Oppurtunistic Infections. Feb 2003. Abstract 875.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Indinavir
Other Study ID Numbers
- P1013
- 10191 (Other Identifier: CTEP)
- ACTG P1013
- PACTG P1013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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