Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000668
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
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:
To determine the pharmacokinetics blood levels of three dose treatment plans of oral ganciclovir during a 28-day dosing period Other purposes of the study are to determine in a population of HIV seropositive persons with cytomegalovirus CMV viremia the safety tolerance and patient acceptability of oral ganciclovir given for 28 days to collect preliminary laboratory evidence for antiviral activity and effectiveness of three dose regimens of oral ganciclovir based on blood and urine cultures of CMV and to relate antiviral activity to dosage and to serum ganciclovir levels
CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls More studies are warranted to evaluate effects at different doses
CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls More studies are warranted to evaluate effects at different doses
Detailed Description:
CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls More studies are warranted to evaluate effects at different doses
In group A 36 HIV seropositive patients with CMV viruria receive a single dose of intravenous ganciclovir followed by one of three oral dose regimens for 28 days Twelve individuals are treated at each dose level In group B 12 patients with AIDS and CMV retinitis receive oral ganciclovir therapy These 12 patients must have received an induction course of intravenous ganciclovir for 4 weeks prior to study entry and must have stable CMV retinitis Measurements for both groups include pharmacokinetics safety and tolerance history physical examination hematology and serum chemistry and CMV blood and urine cultures In addition there are weekly ophthalmologic evaluations for individuals in the group B study
In group A 36 HIV seropositive patients with CMV viruria receive a single dose of intravenous ganciclovir followed by one of three oral dose regimens for 28 days Twelve individuals are treated at each dose level In group B 12 patients with AIDS and CMV retinitis receive oral ganciclovir therapy These 12 patients must have received an induction course of intravenous ganciclovir for 4 weeks prior to study entry and must have stable CMV retinitis Measurements for both groups include pharmacokinetics safety and tolerance history physical examination hematology and serum chemistry and CMV blood and urine cultures In addition there are weekly ophthalmologic evaluations for individuals in the group B study
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 |
|---|---|---|---|
| 11102 | REGISTRY | DAIDS ES Registry Number | None |
| ICM 1505 | None | None | None |
| FDA 37A | None | None | None |
| RS-21592 | None | None | None |