Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002334
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine AZT Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Multicenter Double-Blind Phase III Parallel Study of Zidovudine AZT Alone Versus AZT Plus Zalcitabine Dideoxycytidine ddC Versus AZT Plus Saquinavir Mesylate Ro 31-8959 HIV Proteinase Inhibitor Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to 350 Cellsmm3
Status:
COMPLETED
Status Verified Date:
1996-09
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 compare in zidovudine AZT-naive patients the safety tolerance and efficacy of saquinavir mesylate Ro 31-8959 alone versus AZT alone versus AZT in combination with Ro 31-8959 zalcitabine ddC or both To compare various disease markers among the different regimens
Detailed Description:
Patients are randomized to receive a minimum of 80 weeks of AZT alone AZT plus ddC AZT plus Ro 31-8959 or all three drugs
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 |
|---|---|---|---|
| SV 14604A | None | None | None |
| SV 14604C | None | None | None |