Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002023
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
An Oral Dose-Ranging Finding Study in Patients With HIV Disease CDC Classification Groups IIB III and IV-C2
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Oral Dose-Ranging Finding Study in Patients With HIV Disease CDC Classification Groups IIB III and IV-C2
Status:
COMPLETED
Status Verified Date:
1995-02
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 establish the relationship between the oral dose of zidovudine AZT and its hematologic toxicity AZT has preliminarily been shown to decrease significant events and death in a group of AIDS Pneumocystis carinii pneumonia PCP and AIDS related complex ARC patients followed at this time for a limited period If these data withstand further follow-up it appears that AZT is a potential antiretroviral agent that may have application in the use of all stages of HIV disease At this time the optimal dose that will not cause significant toxicity is not known If this drug has widespread application it becomes imperative to further study both the dose and the toxicity Patients with documented HIV viremia and who are well will be evaluated in a dose-escalating protocol for toxicity persistent viremia evidence of improvement of immune dysfunction and the development of further manifestation of HIV disease Drug levels will be monitored and correlated with the toxicity and viremia
Detailed Description:
None
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 |
|---|---|---|---|
| 013 | None | None | None |