Last updated on June 2005

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


Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT00017992

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USC School of Medicine / LA County Med Ctr
Los Angeles, CA United States
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Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, FL United States
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Univ of Miami
Miami, FL United States
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Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, NY United States
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New York Hosp / Cornell Med Ctr
New York, NY United States
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St Luke's - Roosevelt Hosp Ctr
New York, NY United States
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State Univ of New York at Stony Brook
Stony Brook, NY United States
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Saint Jude Children's Research Hosp of Memphis
Memphis, TN United States
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Fundacion HUES
Buenos Aires, Argentina
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Instituto Mexicano de Investigacion Clinica
Col Roma, Mexico
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Hospital del Nino
Panama City, Panama
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Univ of Puerto Rico / Med Science Campus
San Juan, Puerto Rico
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Dr. Avy Violari

Perinatal HIV Research UNIT
Diepkloof, South Africa
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Pauline Francesca Conradie

Infectious Diseases Clinincal Trial Unit
Gaunteng, South Africa
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