Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000768
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
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 oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus CMV GI disease and to compare the bioavailability of these regimens to that of standard intravenous IV ganciclovir
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration but an optimum dose has not been determined Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration but an optimum dose has not been determined Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug
Detailed Description:
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration but an optimum dose has not been determined Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug
All patients receive an induction regimen of IV ganciclovir administered twice daily for 21 to 42 Per Amendment 3495 days A permanent venous catheter is implanted for the induction therapy If clinically improved following induction patients are then randomized to receive one of three doses of oral ganciclovir given first without and then with oral glutamic acid hydrochloride every 8 hours until they reach a steady state PER AMENDMENT 31495 After subjects have reached steady state with oral ganciclovir and glutamic acid hydrochloride then PK samples will be taken Subjects will continue the dosing regimen they were assigned to glutamic acid hydrochloride will be added if it resulted in at least 33 increased bioavailability for up to 12 months or until relapse of CMV GI disease is documented Subjects will be followed at monthly intervals for safety evaluation and for evidence of CMV GI relapse Subjects who have clinical symptoms of relapse will undergo repeat endoscopy or colonoscopy to document the relapse
All patients receive an induction regimen of IV ganciclovir administered twice daily for 21 to 42 Per Amendment 3495 days A permanent venous catheter is implanted for the induction therapy If clinically improved following induction patients are then randomized to receive one of three doses of oral ganciclovir given first without and then with oral glutamic acid hydrochloride every 8 hours until they reach a steady state PER AMENDMENT 31495 After subjects have reached steady state with oral ganciclovir and glutamic acid hydrochloride then PK samples will be taken Subjects will continue the dosing regimen they were assigned to glutamic acid hydrochloride will be added if it resulted in at least 33 increased bioavailability for up to 12 months or until relapse of CMV GI disease is documented Subjects will be followed at monthly intervals for safety evaluation and for evidence of CMV GI relapse Subjects who have clinical symptoms of relapse will undergo repeat endoscopy or colonoscopy to document the relapse
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 |
|---|---|---|---|
| 11158 | REGISTRY | DAIDS ES Registry Number | None |