The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
A Phase IA Single Dose Pharmacokinetics and Safety Study of the Oral Antiviral Compound, 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) (Adefovir Dipivoxil) in Children With HIV-1 Infection
1 other identifier
interventional
24
2 countries
10
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372322581, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
Related Publications (1)
McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hughes W
- STUDY CHAIR
Shenep J