Project no.: HIV-NAT 007
Background:
- The pediatric oral powder formulation of Nelfinavir has been studied in small groups of HIV-infected children
- Serveral small pediatric trials suggest Nelfinavir as part of a combination regimen is generally well tolerated and has the same potential clinical benefit that have been noted in adults
- This study will provide information to be used further in a propose phase 3 study
Study population: 12-36 evaluable newborn infants born to HIV-infected women
Regimen:
- Nelfinavir 15 mg/kg PO every 12 hours*
- d4T 1 mg/kg PO every 12 hours
- ddI 100 mg/m2 PO every 24 hours
*Analysis of the pharmacokinetic data from the first cohort (21 infants) may require recruitment for the next cohort in which Nelfinavir dose will be increased (30 mg/kg & 45 mg/kg BID)
Objectives:
- To access the safety and tolerance of the triple combination regimen of Nelfinavir, d4T and ddI in HIV-exposed newborn infants
- To determine the appropriate dosage of Nelfinavir and to access its pharmacokinetics when given in combination with d4T and ddI in HIV-exposed newborn infants
Study Design:
- An open label, dose-escalating, multiple-dose pharmacokinetic study
- The regimen will be administered to infants, within 12 hours of birth born to HIV-infected women all of whom should have received Zidovudine prophylactic regimen during pregnency and labor as standard of care
- In addition to receiving d4T and ddI, infants will receive Nelfinavir 15 mg/kg BID for the first cohort, 30 mg/kg BID for the second cohort and 45 mg/kg for the third cohort for a period of 4 weeks
- Quantification of plasma Nelfinavir concentrations and pharmacokinetic analysis will be run on a real time basis and the dose of Nelfinavir adjusted for each cohort as required
- All infants will be followed for 4 months after birth to determine their HIV infection status
