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NCT00000843 · ClinicalTrials.gov registry record · Phase 1
The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00000843 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants.
The verdict
NCT00000843, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DRUG Adefovir dipivoxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000843
The ClinicalTrials.gov registry entry for NCT00000843 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Adefovir dipivoxil is the first listed.
NCT00000843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000843 about?
NCT00000843 is a clinical study titled "The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children". 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. Alth...
What is the current status of trial NCT00000843?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants.
What interventions are being tested in trial NCT00000843?
The interventions under investigation include: Adefovir dipivoxil (DRUG).
Who is sponsoring clinical trial NCT00000843?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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