Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000981
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus CMV in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Efficacy and Safety of Oral FIAC in AIDS Patients With Cytomegalovirus Infection A Dose Ranging Study
Status:
COMPLETED
Status Verified Date:
2012-12
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 find oral doses of FIAC a pyrimidine nucleoside analog that are effective in treating cytomegalovirus CMV viremia in HIV-infected immunocompromised patients to determine tolerance and safety of FIAC in this patient population and to determine pharmacokinetics following multiple doses of FIAC An example of another nucleoside analog effective against retroviruses such as HIV is zidovudine AZT CMV infection is a medically significant opportunistic disease in patients with HIV-related infection The purine nucleoside ganciclovir has been used to treat AIDS patients with CMV disease Although ganciclovir is useful in treating CMV disease such treatment is frequently complicated by hematologic blood toxicity Also treatment is difficult because it requires daily intravenous dosing Test tube studies show that FIAC and its primary breakdown product FIAU are highly and specifically active against several viruses including CMV A single-dose pharmacokinetic blood level study showed that FIAC when taken orally is readily absorbed into the bloodstream and most of it is converted to FIAU
Detailed Description:
CMV infection is a medically significant opportunistic disease in patients with HIV-related infection The purine nucleoside ganciclovir has been used to treat AIDS patients with CMV disease Although ganciclovir is useful in treating CMV disease such treatment is frequently complicated by hematologic blood toxicity Also treatment is difficult because it requires daily intravenous dosing Test tube studies show that FIAC and its primary breakdown product FIAU are highly and specifically active against several viruses including CMV A single-dose pharmacokinetic blood level study showed that FIAC when taken orally is readily absorbed into the bloodstream and most of it is converted to FIAU
Patients are treated as outpatients if general health permits This is continued for up to 90 days or until failure on basis of efficacy tolerance or toxicity The dose escalation between groups of patients uses the formula n 07n Entry of new patients at the next higher dose is based on results of antiviral tolerance and safety data for the prior cohort when they have received at least 14 days of therapy Consecutively qualifying patients are enrolled for each dose group and not based on either disease severity or expected tolerance Although not formally randomized due to the sequential nature of the study and serious medical condition of the patients every attempt to avoid bias in assigning a patient to a dose is made Patients are advised to avoid heavy exercise within 24 hours of any laboratory tests
Patients are treated as outpatients if general health permits This is continued for up to 90 days or until failure on basis of efficacy tolerance or toxicity The dose escalation between groups of patients uses the formula n 07n Entry of new patients at the next higher dose is based on results of antiviral tolerance and safety data for the prior cohort when they have received at least 14 days of therapy Consecutively qualifying patients are enrolled for each dose group and not based on either disease severity or expected tolerance Although not formally randomized due to the sequential nature of the study and serious medical condition of the patients every attempt to avoid bias in assigning a patient to a dose is made Patients are advised to avoid heavy exercise within 24 hours of any laboratory tests
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 |
|---|---|---|---|
| R89-001-01 02 03 04 | None | None | None |