The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
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 Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
100
USC School of Medicine / LA County Med Ctr
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGUniv of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
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Univ of Miami
Miami, Florida, United States
ACTIVE_NOT_RECRUITINGNew York Hosp / Cornell Med Ctr
New York, New York, United States
ACTIVE_NOT_RECRUITINGSt Luke's - Roosevelt Hosp Ctr
New York, New York, United States
ACTIVE_NOT_RECRUITINGState Univ of New York at Stony Brook
Stony Brook, New York, United States
ACTIVE_NOT_RECRUITINGBronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
ACTIVE_NOT_RECRUITINGSaint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
ACTIVE_NOT_RECRUITINGFundacion HUES
Buenos Aires, Argentina
ACTIVE_NOT_RECRUITINGInstituto Mexicano de Investigacion Clinica
Colonia Roma, Mexico
ACTIVE_NOT_RECRUITING...and 4 more locations