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NCT00000805 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00000805 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants.
The verdict
NCT00000805, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral ganciclovir in HIV-infected infants, children, and adolescents. SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV. Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.
Interventions
- DRUG Ganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Est. Completion | 1998-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000805
The ClinicalTrials.gov registry entry for NCT00000805 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 Ganciclovir is the first listed.
NCT00000805 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000805 about?
NCT00000805 is a clinical study titled "A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease". PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral ganciclovir in HIV-infected infants, children, and adolescents. SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV. Maintenance treatment with intravenous (IV) ganciclo...
What is the current status of trial NCT00000805?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. Estimated completion is 1998-03.
What interventions are being tested in trial NCT00000805?
The interventions under investigation include: Ganciclovir (DRUG).
Who is sponsoring clinical trial NCT00000805?
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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