Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000736
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
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 if treatment with zidovudine AZT will delay or prevent the onset of AIDS or AIDS related complex ARC in individuals infected with HIV but who do not have symptoms of AIDS or ARC Also to compare the dose of AZT found to be useful in AIDS and severe ARC with a lower dose to see if side effects can be reduced
Results from several studies show that a high percentage of people infected with HIV will eventually develop AIDS or ARC unless an effective treatment is found Because AZT is known to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in advanced disease it is reasonable to try it in less advanced cases
Results from several studies show that a high percentage of people infected with HIV will eventually develop AIDS or ARC unless an effective treatment is found Because AZT is known to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in advanced disease it is reasonable to try it in less advanced cases
Detailed Description:
Results from several studies show that a high percentage of people infected with HIV will eventually develop AIDS or ARC unless an effective treatment is found Because AZT is known to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in advanced disease it is reasonable to try it in less advanced cases
Patients entered in the study are randomly assigned to one of two doses of AZT or to placebo inactive medication Patients take 3 capsules 5 times a day every 4 hours from 8 am until 12 pm
The capsules contain either AZT or placebo and are identical in appearance so that neither patient nor physician knows which treatment the patient is receiving The higher dose corresponds to the dose found to be useful in patients with AIDS or severe ARC Patients visit the clinic every 2 weeks for the first 16 weeks then once a month after that for evaluation Treatment will continue until the results from the study have been analyzed which could be as long as 3 years If side effects occur the dose of study medication will be decreased or temporarily stopped If the side effects are severe then study medication will be stopped permanently
AMENDED Effective with Version 4 900226 dosing for ALL patients on Phase 2 study drug regardless of CD4 substudy will proceed as open-label AZT Original treatment assignments employed in the 500 cellsmm3 substudy during the period from August 16 1989 through the release of this new version Also toxicity management and dose modification of AZT for patients receiving Phase 2 study drug have been changed
Patients entered in the study are randomly assigned to one of two doses of AZT or to placebo inactive medication Patients take 3 capsules 5 times a day every 4 hours from 8 am until 12 pm
The capsules contain either AZT or placebo and are identical in appearance so that neither patient nor physician knows which treatment the patient is receiving The higher dose corresponds to the dose found to be useful in patients with AIDS or severe ARC Patients visit the clinic every 2 weeks for the first 16 weeks then once a month after that for evaluation Treatment will continue until the results from the study have been analyzed which could be as long as 3 years If side effects occur the dose of study medication will be decreased or temporarily stopped If the side effects are severe then study medication will be stopped permanently
AMENDED Effective with Version 4 900226 dosing for ALL patients on Phase 2 study drug regardless of CD4 substudy will proceed as open-label AZT Original treatment assignments employed in the 500 cellsmm3 substudy during the period from August 16 1989 through the release of this new version Also toxicity management and dose modification of AZT for patients receiving Phase 2 study drug have been changed
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 |
|---|---|---|---|
| 10995 | REGISTRY | DAIDS ES Registry Number | None |