- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00102206
A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies: A Dual PI-Based HAART Regimen Versus a Multi-NRTI ART Regimen, in ART-Experienced Children and Youth Who Have Experienced Virologic Failure
Study Overview
Status
Conditions
Detailed Description
HIV infected children and adolescents on anti-HIV treatment regimens have traditionally had more difficulty with non-adherence and drug resistance than adults, often resulting in virologic failure. Additionally, HIV infected children with extensive exposure to antiretrovirals (ARVs) are likely to have fewer therapeutic options for salvage therapy, and their physicians find it difficult to choose regimens that will keep the HIV infection under control. This study will compare the efficacy of three 4-drug ARV salvage regimens in treatment-experienced, HIV infected children and adolescents who have experienced virologic failure.
This study will last at least 96 weeks. Participants will be randomly assigned to one of three groups. Group 1A will receive a dual-PI based regimen of lopinavir/ritonavir (LPV/r), saquinavir (SQV), and the NRTIs emtricitabine (FTC) and abacavir sulfate (ABC). Group 1B will receive a dual-PI based regimen of LPV/r, SQV, FTC, and tenofovir disoproxil fumarate (TDF). Group 2 will receive an NRTI-only regimen of ABC, lamivudine, zidovudine, and TDF.
There will be 11 study visits during Step I of this study. Medical history, a physical exam, and blood collection will occur at all visits. Dual-energy x-ray absorptiometry (DEXA) scans will occur at study entry and at Weeks 24, 48, 72, and 96. Urine collection will occur at most visits; participants will also take part in adherence modules at most visits. Participants will be asked to complete a pill count form at Weeks 4 and 24. Additionally, some study participants will be asked to participate in an intensive pharmacokinetics study at Week 4.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Illinois
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Chicago, Illinois, United States, 60614
- Chicago Children's CRS
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-
New York
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New York, New York, United States
- Columbia IMPAACT CRS
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Stony Brook, New York, United States, 11794-8111
- SUNY Stony Brook NICHD CRS
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North Carolina
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Durham, North Carolina, United States, 27710
- DUMC Ped. CRS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Step I:
- HIV infected
- No currently available therapeutic options that would likely result in long-term suppression of virus to less than 400 copies/ml
- Two measurements within 4 months prior to screening and at screening of either CD4% of less than 15% and HIV viral load of greater than 10,000 copies/ml OR HIV viral load greater than 30,000 copies/ml
- Previous exposure to non-nucleoside reverse transcriptase inhibitors (NNRTIs), NRTIs, and PIs AND have experienced virologic failure. More information on previous treatment regimen requirements is available in the protocol.
- Prior or current virologic failure with genotypic or phenotypic resistance OR historical virologic failure with a PI- or NNRTI-containing regimen
- Resistance to 2 or more drugs in most recent treatment regimen within 26 weeks prior to study screening
- Able and willing to swallow study medications
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable methods of contraception
Exclusion Criteria for Step I:
- Previous cumulative exposure to TDF for more than 24 weeks OR more than 14 days of TDF exposure during the 24 weeks prior to study entry
- Grade 1 lipase or higher within 28 days prior to study entry
- Grade 3 or higher laboratory abnormality (except for lipase) within 28 days prior to study entry
- History of allergy or hypersensitivity to any of the study drugs
- Active CDC Stage C opportunistic infection or serious bacterial infection requiring therapy at the time of screening
- Chemotherapy for active cancer
- Require certain medications
- Abnormal kidney function
- Any clinically significant diseases other than HIV infection or findings during medical history screening that, in the opinion of the investigator, may interfere with the study
- Pregnancy or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Tolerability of dual PI-based HAART versus multi-NRTI HAART salvage regimens (time to first intolerant event)
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95% confidence interval (CI) for change in CD4% computed for PI-containing groups versus PI-sparing group
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95% CI for change in BMD (both percent change in BMD and change in z-score from baseline) for each treatment group
|
Secondary Outcome Measures
Outcome Measure |
---|
toxicity
|
pharmacokinetics
|
HIV-1 RNA
|
growth and development markers
|
adherence
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special virologic and immunologic parameters
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Andrew Wiznia, MD, Jacobi Medical Center
- Study Chair: Ann J. Melvin, MD, MPH, Seattle Children's Hospital and Regional Medical Center
Publications and helpful links
General Publications
- Brogly S, Williams P, Seage GR 3rd, Oleske JM, Van Dyke R, McIntosh K; PACTG 219C Team. Antiretroviral treatment in pediatric HIV infection in the United States: from clinical trials to clinical practice. JAMA. 2005 May 11;293(18):2213-20. doi: 10.1001/jama.293.18.2213.
- Gavin PJ, Yogev R. The role of protease inhibitor therapy in children with HIV infection. Paediatr Drugs. 2002;4(9):581-607. doi: 10.2165/00128072-200204090-00004.
- Handforth J, Sharland M. Triple nucleoside reverse transcriptase inhibitor therapy in children. Paediatr Drugs. 2004;6(3):147-59. doi: 10.2165/00148581-200406030-00002.
- Neely M, Kovacs A. Management of Antiretroviral Therapy in Neonates, Children, and Adolescents. Curr Infect Dis Rep. 2003 Dec;5(6):521-530. doi: 10.1007/s11908-003-0097-4.
- Piketty C, Race E, Castiel P, Belec L, Peytavin G, Si-Mohamed A, Gonzalez-Canali G, Weiss L, Clavel F, Kazatchkine MD. Efficacy of a five-drug combination including ritonavir, saquinavir and efavirenz in patients who failed on a conventional triple-drug regimen: phenotypic resistance to protease inhibitors predicts outcome of therapy. AIDS. 1999 Jul 30;13(11):F71-7. doi: 10.1097/00002030-199907300-00001.
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
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Tenofovir
- Emtricitabine
- Ritonavir
- Lopinavir
- Lamivudine
- Zidovudine
- Abacavir
- Saquinavir
Other Study ID Numbers
- P1053
- 10131 (Other Identifier: CTEP)
- PACTG P1053
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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