Status:

COMPLETED

The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

1-17 years

Phase:

PHASE1

Brief Summary

To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA ( adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related differences exist. To asc...

Detailed Description

Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmaco...

Eligibility Criteria

Inclusion Criteria

Patients must have:

  • Asymptomatic or mildly symptomatic HIV infection, with no worse than grade 1 toxicity for any symptoms.
  • Consent of parent or guardian.

Prior Medication:

Allowed:

  • IV gammaglobulin and aerosolized pentamidine for PCP prophylaxis.
  • Antiretrovirals if discontinued by 72 hr prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Acute or chronic infections that require treatment during study.

Concurrent Medication:

Excluded:

  • Antiretrovirals other than study drug.
  • Other investigational agents.
  • Immunomodulators.
  • HIV-1 vaccines.
  • Glucocorticoids.
  • Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.
  • TMP / SMX and dapsone.

PER AMENDMENT 8/23/96:

  • Drugs which may affect renal excretion:
  • Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.

Prior Medication:

Excluded within 72 hr prior to study entry:

  • Antiretrovirals other than study drug.
  • Other investigational agents.
  • Immunomodulators.
  • HIV-1 vaccines.
  • Glucocorticoids.
  • Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.
  • TMP / SMX and dapsone.

PER AMENDMENT 8/23/96:

  • Drugs which may affect renal excretion:
  • Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00000843

Last Update

June 24 2005

Active Locations (10)

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Page 1 of 3 (10 locations)

1

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, United States, 941430105

2

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, United States, 32209

3

Chicago Children's Memorial Hosp

Chicago, Illinois, United States, 606143394

4

Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, United States, 212874933

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