Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001011
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Safety and Efficacy of Zidovudine in the Treatment of Patients With Early AIDS Related Complex
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 safety and usefulness of zidovudine AZT for the treatment of patients with early symptomatic HIV infection or early AIDS related complex ARC The ability of AZT to suppress HIV to improve body defenses and to prevent the occurrence or development of AIDS or advanced ARC is being evaluated
In one human study patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections improved in weight and performance and lived longer than patients who received a placebo inactive medication Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL
In one human study patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections improved in weight and performance and lived longer than patients who received a placebo inactive medication Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL
Detailed Description:
In one human study patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections improved in weight and performance and lived longer than patients who received a placebo inactive medication Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL
Patients accepted into the study are randomly assigned to receive either AZT or placebo Treatment continues for a minimum of 104 weeks beyond the time the last patient enters the study If the study medication causes toxic effects the dose is decreased or temporarily stopped and if the toxic effects are severe then the medication will be stopped permanently Participants visit the clinic every 2 weeks during the first 16 weeks and once a month thereafter Throughout the study frequent blood samples are taken to monitor the effectiveness and safety of the treatment AMENDED The placebo arm has been discontinued as of August 3 1989 and the AZT dose has been reduced
Patients accepted into the study are randomly assigned to receive either AZT or placebo Treatment continues for a minimum of 104 weeks beyond the time the last patient enters the study If the study medication causes toxic effects the dose is decreased or temporarily stopped and if the toxic effects are severe then the medication will be stopped permanently Participants visit the clinic every 2 weeks during the first 16 weeks and once a month thereafter Throughout the study frequent blood samples are taken to monitor the effectiveness and safety of the treatment AMENDED The placebo arm has been discontinued as of August 3 1989 and the AZT dose has been reduced
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 |
|---|---|---|---|
| 10992 | REGISTRY | DAIDS ES Registry Number | None |