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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00016718 |
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study is to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who have taken few or no anti-HIV drugs.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Didanosine Drug: Efavirenz Drug: Emtricitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity, and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected, Antiretroviral Therapy Naive or Very Limited Antiretroviral Exposed Pediatric Subjects |
Enrollment: | 53 |
Study Start Date: | June 2005 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
All patients will receive ddI, EFV, and FTC together once daily. Study visits will occur at study entry, Weeks 2 and 4, and every 4 weeks thereafter.
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Drug: Didanosine
Antiretroviral
Drug: Efavirenz
Antiretroviral
Drug: Emtricitabine
Antiretroviral
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Anti-HIV treatment options are limited for pediatric patients because combination therapies recommended for adults may not be appropriate for children or adolescents. Few PIs are available in formulations appropriate for pediatric patients, and complex dosing schedules and food requirements may be detrimental to treatment adherence. A once-daily regimen of the NRTIs ddI and FTC and the nonnucleoside reverse transcriptase inhibitor (NNRTI) EFV has been shown safe and well tolerated in adults. This study will evaluate the long-term safety and efficacy of a ddI, FTC, and EFV regimen in pediatric patients.
Patients will be followed for a maximum of 192 weeks; all patients will receive ddI, EFV, and FTC together once daily. Study visits will occur at study entry, Weeks 2 and 4, and every 4 weeks thereafter. Blood collection, medical history assessment, and a physical exam will occur at all visits; urine collection will occur at selected visits. Intensive pharmacokinetic (PK) studies will be done at Weeks 2 and 12 to determine if dose adjustments are required for any of the drugs. If virologic failure is determined, PK studies will be repeated 4 weeks after adjustments in therapy. Parents or guardians will be asked to complete treatment adherence questionnaires at some visits. Some patients may also be asked to participate in an additional PK study after Week 16 or week 96.
Ages Eligible for Study: | 90 Days to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Ross E. McKinney, Jr., MD | Duke University |
Study Chair: | Mobeen H. Rathore, MD | Pediatric Infectious Diseases/Immunology, University of Florida Health Science Center |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG P1021, PACTG P1021, IMPAACT P1021 |
Study First Received: | May 31, 2001 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00016718 |
Health Authority: | United States: Food and Drug Administration |
Didanosine Drug Therapy, Combination Drug Administration Schedule Reverse Transcriptase Inhibitors Anti-HIV Agents |
Pharmacokinetics Deoxycytidine Efavirenz Treatment Naive |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Didanosine Emtricitabine |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |