Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000726
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
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 explore the safety and usefulness of foscarnet an antiviral agent in the treatment of cytomegalovirus CMV retinitis Untreated CMV retinitis is a rapidly progressive blinding disease in AIDS patients The manner in which foscarnet breaks down in the body and the effect of increasing periodic intravenous doses are also studied Foscarnet is active in vitro test tube against herpes viruses including CMV by inhibiting the virus DNA polymerases enzymes necessary for virus replication without affecting cellular DNA polymerases Opportunistic CMV disease in AIDS is usually seen as retinitis colitis esophagitis hepatitis pancreatitis encephalitis or pneumonia Ganciclovir has been used to treat AIDS patients with CMV disease but can cause severe neutropenia very low neutrophil cell counts Foscarnet does not suppress the production of neutrophils or other leukocytes myelosuppression and has shown in vitro activity against HIV
Detailed Description:
Foscarnet is active in vitro test tube against herpes viruses including CMV by inhibiting the virus DNA polymerases enzymes necessary for virus replication without affecting cellular DNA polymerases Opportunistic CMV disease in AIDS is usually seen as retinitis colitis esophagitis hepatitis pancreatitis encephalitis or pneumonia Ganciclovir has been used to treat AIDS patients with CMV disease but can cause severe neutropenia very low neutrophil cell counts Foscarnet does not suppress the production of neutrophils or other leukocytes myelosuppression and has shown in vitro activity against HIV
Treatment is given for a total of 10 weeks with a 2-week induction regimen followed by randomization to daily maintenance foscarnet for 8 weeks If induction therapy is tolerated without unexpected toxicity patients are allowed to self-administer foscarnet at home via central venous catheter and may receive up to 11 days of induction therapy by self-administration on an outpatient basis Foscarnet will be administered in open-label fashion so that both investigator and patient will know the dose Within the study there are 8 patients who upon entering the 2nd week of maintenance foscarnet therapy are treated with zidovudine AZT
Treatment is given for a total of 10 weeks with a 2-week induction regimen followed by randomization to daily maintenance foscarnet for 8 weeks If induction therapy is tolerated without unexpected toxicity patients are allowed to self-administer foscarnet at home via central venous catheter and may receive up to 11 days of induction therapy by self-administration on an outpatient basis Foscarnet will be administered in open-label fashion so that both investigator and patient will know the dose Within the study there are 8 patients who upon entering the 2nd week of maintenance foscarnet therapy are treated with zidovudine AZT
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 |
|---|---|---|---|
| 10991 | REGISTRY | DAIDS ES Registry Number | None |
| FDA 20D | None | None | None |