Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002367
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine AZT and Lamivudine 3TC in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy
Status:
COMPLETED
Status Verified Date:
1997-08
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 evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy
Detailed Description:
All enrolled patients will receive the following 3 drug combination Saquinavir Zidovudine and Lamivudine Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels Patients below the detectable limit of 200 copiesml will be analyzed using the Ultra-direct method with a detection limit of 20 copiesml CD4 and CD8 cell counts will also be analyzed
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 |
|---|---|---|---|
| M61005 | None | None | None |
| NR15503 | None | None | None |