Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001989
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Phase II Efficacy Activity and Safety Study of GLQ223 Alone and in Combination With Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment With GLQ223 or Trichosanthin
Sponsor:
Genelabs Technologies
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Phase II Efficacy Activity and Safety Study of GLQ223 Alone and in Combination With Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment With GLQ223 or Trichosanthin
Status:
COMPLETED
Status Verified Date:
1992-10
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:
This study involves GLQ223 administration to patients who have not previously been exposed to it but who have received at least 9 months of zidovudine therapy Efficacy evaluations will include survival opportunistic infections T4 cell count and assessments of viral load
Detailed Description:
The study will involve the randomization of patients with 200-500 T4 cells and AIDS or ARC to one of three treatment arms zidovudine alone GLQ223 alone or GLQ223 plus zidovudine Patients randomized to receive GLQ223 will receive an infusion every three weeks for 45 weeks
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?: