Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
- Conditions
- HIV Infections
- Registration Number
- NCT00017992
- Lead Sponsor
- Triangle Pharmaceuticals
- Brief Summary
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
USC School of Medicine / LA County Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Miami
🇺🇸Miami, Florida, United States
Instituto Mexicano de Investigacion Clinica
🇲🇽Col Roma, Mexico
Infectious Diseases Clinincal Trial Unit
🇿🇦Gaunteng, South Africa
Fundacion HUES
🇦🇷Buenos Aires, Argentina
Hospital del Nino
🇵🇦Panama City, Panama
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
St Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
New York Hosp / Cornell Med Ctr
🇺🇸New York, New York, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Univ of Puerto Rico / Med Science Campus
🇵🇷San Juan, Puerto Rico
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Perinatal HIV Research UNIT
🇿🇦Diepkloof, South Africa