Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002079
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin SC-48334 and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4 Cellsmm3 NOTE Asymptomatic HIV-1 Infected Patients Also Eligible
Sponsor:
G D Searle
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin SC-48334 and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4 Cellsmm3 NOTE Asymptomatic HIV-1 Infected Patients Also Eligible
Status:
COMPLETED
Status Verified Date:
1993-03
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 assess the dose-related antiviral effects of SC-48334 and zidovudine AZT administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4 cellsmm3 To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4 cellsmm3 and to assess the pharmacokinetics of the two drugs given separately and in combination
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 |
|---|---|---|---|
| NS8-91-02-009 | None | None | None |