Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001002
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy
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 study the toxicity pharmacokinetics and antiretroviral effectiveness of combined oral zidovudine AZT and intermittent intravenous foscarnet therapy in stable AIDS or AIDS related complex ARC patients who have already received AZT for 8 - 52 weeks
It is hypothesized that the maximum AZT antiretroviral effect which occurs at 8 weeks of therapy will be enhanced by 2 weeks of foscarnet treatment given at the same time by intermittent intravenous infusion In addition the further lowering of serum p24 antigen concentration that should occur during combined therapy might continue when oral AZT therapy is continued without foscarnet
It is hypothesized that the maximum AZT antiretroviral effect which occurs at 8 weeks of therapy will be enhanced by 2 weeks of foscarnet treatment given at the same time by intermittent intravenous infusion In addition the further lowering of serum p24 antigen concentration that should occur during combined therapy might continue when oral AZT therapy is continued without foscarnet
Detailed Description:
It is hypothesized that the maximum AZT antiretroviral effect which occurs at 8 weeks of therapy will be enhanced by 2 weeks of foscarnet treatment given at the same time by intermittent intravenous infusion In addition the further lowering of serum p24 antigen concentration that should occur during combined therapy might continue when oral AZT therapy is continued without foscarnet
There is a 4-week prestudy monitoring period during which AZT alone is administered on an outpatient basis followed by a 2-week study period during which both intravenous foscarnet and oral AZT are administered in the hospital During the subsequent 6-month follow-up period oral AZT is administered and patients receive clinical evaluations AZT is held for 48 hours on days before hospitalization and for 24 hours at the end of the hospitalization
There is a 4-week prestudy monitoring period during which AZT alone is administered on an outpatient basis followed by a 2-week study period during which both intravenous foscarnet and oral AZT are administered in the hospital During the subsequent 6-month follow-up period oral AZT is administered and patients receive clinical evaluations AZT is held for 48 hours on days before hospitalization and for 24 hours at the end of the hospitalization
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 |
|---|---|---|---|
| 11027 | REGISTRY | DAIDS ES Registry Number | None |