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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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 ascertain dosages that may be suitable for a multiple-dose evaluation in this patient population. 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 pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children.

Key facts

Study ID

NCT00000843

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl — Newark, New Jersey, United States
• Children's Hosp of Philadelphia — Philadelphia, Pennsylvania, United States
• Saint Jude Children's Research Hosp of Memphis — Memphis, Tennessee, United States
• Vanderbilt Univ Med Ctr — Nashville, Tennessee, United States
• Univ of Puerto Rico / Univ Children's Hosp AIDS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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