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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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