Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000999
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Zidovudine AZT in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Uncontrolled Trial To Evaluate the Long Term Safety and Tolerance of Zidovudine AZT in the Treatment of Human Immunodeficiency Virus HIV Infection in Patients With AIDS and Advanced 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 obtain information about the long-term safety and toxicity of zidovudine AZT To ascertain whether interruptionresumption at a lower dosage is the optimal management of AZT toxicity
Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment it is valuable to continue to get information on the long-term toxicity of AZT
Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment it is valuable to continue to get information on the long-term toxicity of AZT
Detailed Description:
Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment it is valuable to continue to get information on the long-term toxicity of AZT
This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling Patients are randomized to 1 of 2 regimens for management of toxicity
This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling Patients are randomized to 1 of 2 regimens for management of toxicity
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 |
|---|---|---|---|
| 10996 | REGISTRY | DAIDS ES Registry Number | None |