Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000729
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL andor Constitutional Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL andor Constitutional Disease
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 toxicity of low dose foscarnet administered for 4 weeks to HIV infected patients who are asymptomatic have AIDS or other HIV associated conditions and a CD4 lymphocyte count 500 cellsmm3 To obtain preliminary efficacy data Although zidovudine AZT has been effective in treating some AIDS patients AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated In vitro test tube studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses including HIV are sensitive to it It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS
Detailed Description:
Although zidovudine AZT has been effective in treating some AIDS patients AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated In vitro test tube studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses including HIV are sensitive to it It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS
Patients are divided into three groups 1 asymptomatic patients with or without persistent generalized lymphadenopathy PGL syndrome 2 patients with AIDS and 3 patients who have or have had mild to moderate signs or symptoms consistent with HIV infection Patients are then randomly chosen to receive one of three different foscarnet doses The drug is given for 4 weeks by 1-hour infusion administered every 8 hours In addition those patients who are clinically stable and have not experienced severe toxicity at the end of the 4 weeks may continue treatment in the form of a single daily dose of foscarnet to be administered 5 days per week Blood samples are taken during treatment and at the first fourth and eighth week after treatment If the patient is on maintenance blood samples are taken weekly Effective 7-17-89 patients entering the study are assigned to the lowest foscarnet dose Patients receive daily treatment for 28 days Patients who are clinically stable without severe toxicity at 4 weeks have the option of maintenance therapy with foscarnet
Patients are divided into three groups 1 asymptomatic patients with or without persistent generalized lymphadenopathy PGL syndrome 2 patients with AIDS and 3 patients who have or have had mild to moderate signs or symptoms consistent with HIV infection Patients are then randomly chosen to receive one of three different foscarnet doses The drug is given for 4 weeks by 1-hour infusion administered every 8 hours In addition those patients who are clinically stable and have not experienced severe toxicity at the end of the 4 weeks may continue treatment in the form of a single daily dose of foscarnet to be administered 5 days per week Blood samples are taken during treatment and at the first fourth and eighth week after treatment If the patient is on maintenance blood samples are taken weekly Effective 7-17-89 patients entering the study are assigned to the lowest foscarnet dose Patients receive daily treatment for 28 days Patients who are clinically stable without severe toxicity at 4 weeks have the option of maintenance therapy with foscarnet
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 |
|---|---|---|---|
| 11004 | REGISTRY | DAIDS ES Registry Number | None |