Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000791
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine ZDV Versus ZDV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine ZDV Versus ZDV
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 anti-HIV activity of two doses of SC-49483 in combination with zidovudine AZT versus AZT alone To determine the influences of viral phenotype on the anti-HIV activity of these treatment regimens
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334 which has demonstrated anti-HIV activity Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334 the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334 which has demonstrated anti-HIV activity Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334 the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection
Detailed Description:
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334 which has demonstrated anti-HIV activity Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334 the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection
Patients are randomized to receive AZT alone or in combination with one of two doses of SC-49483 administered three times daily Treatment continues for 16 to 24 weeks Per 071994 amendment At the end of 24 weeks blinded treatment continues for an additional 4 weeks at which time patients may receive open-label drug on an optional basis for 90 days
Patients are randomized to receive AZT alone or in combination with one of two doses of SC-49483 administered three times daily Treatment continues for 16 to 24 weeks Per 071994 amendment At the end of 24 weeks blinded treatment continues for an additional 4 weeks at which time patients may receive open-label drug on an optional basis for 90 days
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 |
|---|---|---|---|
| 11236 | REGISTRY | DAIDS-ES | None |