Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001006
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of AS-101 in Patients With AIDS or AIDS Related Complex ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase One Study of AS-101 in Patients With Acquired Immune Deficiency Syndrome AIDS or AIDS-Related Complex ARC
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 toxic effects of AS-101 at various doses in patients with AIDS or AIDS related complex Also to determine the effect of various doses of AS-101 on immune functions and the occurrence of infections in these patients AIDS is a viral disease that is characterized by a loss of some immune function and the development of frequent eventually fatal infectious diseases Although zidovudine AZT has prolonged survival in some patients with AIDS AZT is quite toxic and there is a need for more effective and less toxic drugs AS-101 is a synthetic organic compound containing the metal tellurium that is being tested because in laboratory studies it improved immune functions
Detailed Description:
AIDS is a viral disease that is characterized by a loss of some immune function and the development of frequent eventually fatal infectious diseases Although zidovudine AZT has prolonged survival in some patients with AIDS AZT is quite toxic and there is a need for more effective and less toxic drugs AS-101 is a synthetic organic compound containing the metal tellurium that is being tested because in laboratory studies it improved immune functions
Patients are given intravenous infusions of AS-101 3 times a week for 12 weeks The first group of 6 patients receives a dose that did not cause toxic effects in a preliminary study If no adverse effects occur the next 6 patients receive a higher dose level and so on until an optimum dose has been reached The investigators will determine the optimum dose based on the type and severity of adverse effects experienced by the patients on the study and by the effect of the drug on the immune function of the patient and its effect on the HIV infection Samples of blood and urine are taken periodically during the study and skin tests are performed 3 times to aid in the evaluation of AS-101 Patients receive standard treatment for any infections that develop during the study
Patients are given intravenous infusions of AS-101 3 times a week for 12 weeks The first group of 6 patients receives a dose that did not cause toxic effects in a preliminary study If no adverse effects occur the next 6 patients receive a higher dose level and so on until an optimum dose has been reached The investigators will determine the optimum dose based on the type and severity of adverse effects experienced by the patients on the study and by the effect of the drug on the immune function of the patient and its effect on the HIV infection Samples of blood and urine are taken periodically during the study and skin tests are performed 3 times to aid in the evaluation of AS-101 Patients receive standard treatment for any infections that develop during the study
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 |
|---|---|---|---|
| 11020 | REGISTRY | DAIDS ES Registry Number | None |