Optimizing Antiretroviral Therapy in HIV-Infected Children and Adolescents

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a feasibility study aimed at elevating protease inhibitors (PI) dosage as a part of active antiretroviral therapy (HAART). After the pharmacokinetics for the currently prescribed PI were determined,patients with a vIQ<1 were eligible for a 50% dose increase for an 8 week time frame after which their vIQ would be reassessed to determine if increasing their PI dosage thereby increasing the bioavaiability would reduce their viral load.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's National Research Institute; Children's Research Institute
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion criteria:

• Evidence of HIV infection confirmed by positive culture or PCR on at least two occasions, or a positive ELISA and a confirmatory Western Blot. At least one of these tests must be done in an ACTG certified laboratory which is approved to perform the assay for protocol testing

• Age 4-21 years

• Current use of HAART regimen (NRTI or/and NNRTI based) containing a PI

• HIV-RNA levels above 1,000 copies/mL (Stage II)

• vIQ<1 for Kaletra

• Signed informed consent and, if indicated, signed informed assent or waiver of assent.

Exclusion criteria:

• Grade 3-4 DAIDS defined toxicity

• Use of cimetidine (used as the internal standard for the HPLC-MS/MS assay)

• Any active opportunistic infection

• Any of the following laboratory findings at entry: absolute neutrophil count <750 cells/mm3; platelet count <75,000 cells/mm3; AST >3 times upper limit of age adjusted normal values; ALT >3 times upper limit of age adjusted normal values; serum creatinine >1.2mg/dL.

• Patients on dual PI regimen (except when second PI is given for boosting) at the time of enrollment