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Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV

HIV Infections Clinical Trial

Official title:
An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients

Clinical Trial Summary

The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Pharmacodynamics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00017992
Study type Interventional
Source NIH AIDS Clinical Trials Information Service
Contact
Status Recruiting
Phase Phase 2
View Details
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