Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002333
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Saquinavir and Zalcitabine Used Alone and Together in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Parallel Study of Ro 31-8959 Saquinavir HIV Proteinase Inhibitor Alone HIVID Dideoxycytidine Zalcitabine ddC Alone and Both in Combination as Treatment for Advanced HIV Infection CD4 50-300 Cellsmm3 in Patients Discontinuing or Unable to Take Retrovir Zidovudine AZT Therapy
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 compare the safety tolerance and efficacy of saquinavir mesylate Ro 31-8959 alone zalcitabine dideoxycytidine ddC alone and both in combination in patients discontinuing or unable to take zidovudine AZT
Detailed Description:
Patients are randomized to one of three treatment regimens ddC alone Ro 31-8959 alone and ddC plus Ro 31-8959 Treatment continues for at least 48 weeks Patients are stratified by baseline CD4 count Per 092694 amendment a fourth arm lower dose Ro 31-8959 plus ddC was discontinued
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 |
|---|---|---|---|
| NV 14256A | None | None | None |
| NV 14256B | None | None | None |