Optimizing Antiretroviral Therapy in HIV-Infected Children and Adolescents

Stopped early

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00207948

Run by

Children's National Research Institute

People needed

4

Starts

2004-11-01

Expected to finish

2009-07-01

Last updated by the study team

2015-08-05

Who can join

Age: 4 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.