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Status:

TERMINATED

Optimizing Antiretroviral Therapy in HIV-Infected Children and Adolescents

Lead Sponsor:

Children's National Research Institute

Conditions:

HIV Infections

Eligibility:

All Genders

4-21 years

Brief 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 dete...

Detailed Description

Although, the use of protease inhibitors (PI) containing highly active antiretroviral therapy (HAART) has led to a remarkable improvement in the prognosis and outcome of HIV infection, only 45% to 70%...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2004

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2009

    Estimated Enrollment :

    4 Patients enrolled

    Trial Details

    Trial ID

    NCT00207948

    Start Date

    November 1 2004

    End Date

    July 1 2009

    Last Update

    August 5 2015

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Children's National Medical Center

    Washington D.C., District of Columbia, United States, 20010