Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000995
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus CMV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Studies of the Combination of AZT and DHPG Ganciclovir in Patients With AIDS and Cytomegalovirus Infection
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 evaluate the clinical and laboratory toxicity of ganciclovir GCV and zidovudine AZT when given in combination
Because recent information has shown AZT to be useful in treating AIDS it is assumed that most patients with AIDS and probably with AIDS related complex ARC will be receiving AZT Because AZT is reported not to be active against cytomegalovirus CMV it is important to see if it is useful to give GCV along with AZT
Because recent information has shown AZT to be useful in treating AIDS it is assumed that most patients with AIDS and probably with AIDS related complex ARC will be receiving AZT Because AZT is reported not to be active against cytomegalovirus CMV it is important to see if it is useful to give GCV along with AZT
Detailed Description:
Because recent information has shown AZT to be useful in treating AIDS it is assumed that most patients with AIDS and probably with AIDS related complex ARC will be receiving AZT Because AZT is reported not to be active against cytomegalovirus CMV it is important to see if it is useful to give GCV along with AZT
Patients are placed into one of four groups at entry into study according to their previous treatment
I Prior treatment with AZT up to the time of developing CMV infection and not requiring dose reduction of AZT for toxicity
II Prior treatment with AZT up to the time of developing CMV infection and requiring dose reduction of AZT for toxicity
III Prior therapy with GCV for CMV infection These patients should already be in the maintenance phase having completed a minimum of 2 weeks of induction therapy
IV No prior therapy with either AZT or GCV
Treatment lasts 24 weeks and consists of two treatment plans
A Patients not previously treated with GCV are started on GCV for an additional 22 weeks GCV is given as a 1-hour infusion All patients are started on AZT at the lowest dose B For patients with chronic CMV disease who are receiving GCV maintenance GCV is administered as a 1-hour infusion 5 daysweek
AZT is added and treatment with GCV is standardized prior to beginning of the study
Patients are placed into one of four groups at entry into study according to their previous treatment
I Prior treatment with AZT up to the time of developing CMV infection and not requiring dose reduction of AZT for toxicity
II Prior treatment with AZT up to the time of developing CMV infection and requiring dose reduction of AZT for toxicity
III Prior therapy with GCV for CMV infection These patients should already be in the maintenance phase having completed a minimum of 2 weeks of induction therapy
IV No prior therapy with either AZT or GCV
Treatment lasts 24 weeks and consists of two treatment plans
A Patients not previously treated with GCV are started on GCV for an additional 22 weeks GCV is given as a 1-hour infusion All patients are started on AZT at the lowest dose B For patients with chronic CMV disease who are receiving GCV maintenance GCV is administered as a 1-hour infusion 5 daysweek
AZT is added and treatment with GCV is standardized prior to beginning of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10980 | REGISTRY | DAIDS ES Registry Number | None |