Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000805
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
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
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
Patients are assigned to 1 of 5 PER AMENDMENT 102495 was 4 oral syrup or capsules dose levels following a single intravenous dose of ganciclovir Treatment continues for 72 PER AMENDMENT 102495 was 24 weeks weeks after the last patient has been enrolled
Patients are assigned to 1 of 5 PER AMENDMENT 102495 was 4 oral syrup or capsules dose levels following a single intravenous dose of ganciclovir Treatment continues for 72 PER AMENDMENT 102495 was 24 weeks weeks after the last patient has been enrolled
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11203 | REGISTRY | DAIDS ES Registry Number | None |