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Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV
This study is currently recruiting patients.
Sponsored by: | Triangle Pharmaceuticals |
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Information provided by: | AIDS Clinical Trials Information Service |
Purpose
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
Condition | Treatment or Intervention | Phase |
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HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Emtricitabine Drug: Stavudine |
Phase II |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Pharmacodynamics Study
Official Title: An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination with Other Antiretroviral Agents in HIV-Infected Pediatric Patients
Expected Total Enrollment: 100
Children are placed into 1 of 4 treatment groups based on age: Group 1, 3 months to 24 months; Group 2, 25 months to 6 years; Group 3, 7 years to 12 years; Group 4, 13 years to 17 years. They receive baseline evaluations. Antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavir/ritonavir. Antiretroviral-experienced patients replace lamivudine with emtricitabine. Patients return to the clinic for follow-up visits at Weeks 2 and 4 and then every 4 weeks until Week 48. Safety is evaluated using adverse events, which are reviewed at every clinic visit. Clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits. After the Week 48 study evaluations are completed, individual patients may continue to receive study medication (as provided by the sponsor) until commercially available, if certain criteria are met.
Eligibility
Ages Eligible for Study: 3 Months - 17 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Children may be eligible for this study if they:
Exclusion Criteria
Children will not be eligible for this study if they:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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