Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002383
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Parallel Open-Label Study Comparing Saquinavir Hard Gelatin Formulation 600 Mg Tid to Saquinavir Soft Gelatin Formulation 400 Mg 800 Mg 1200 Mg Tid x 4 Weeks in HIV Infected Patients
Status:
COMPLETED
Status Verified Date:
1997-07
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 antiviral activity safety and pharmacokinetics of saquinavir hard gel capsule HGC formulation to 1 of 3 doses of saquinavir soft gel capsule SGC formulation administered orally every 8 hours for 4 weeks
Detailed Description:
Patients are randomly assigned to one of the four treatment groups as follows
Group 1 10 patients receive saquinavir HGC Group 2 10 patients receive saquinavir SGC Group 3 30 patients receive saquinavir SGC at an intermediate dose Group 4 30 patients receive saquinavir SGC at the highest study dose Upon completion of the initial 4 weeks all patients may have the option to continue their originally-assigned therapy as monotherapy unless significant drug toxicity intervenes If the analysis of the initial 4 week data identifies an optimal dose of saquinavir SGC patients may have the option to change to this optimal dose in a treatment extension phase of the protocol Patients in this extension phase may choose to remain on monotherapy unless they experience significant drug toxicity their CD4 count or HIV-RNA levels return to baseline until saquinavir is approved by the FDA or study termination whichever comes first
NOTE A washout 28 days is required for patients on antiretroviral therapy
Group 1 10 patients receive saquinavir HGC Group 2 10 patients receive saquinavir SGC Group 3 30 patients receive saquinavir SGC at an intermediate dose Group 4 30 patients receive saquinavir SGC at the highest study dose Upon completion of the initial 4 weeks all patients may have the option to continue their originally-assigned therapy as monotherapy unless significant drug toxicity intervenes If the analysis of the initial 4 week data identifies an optimal dose of saquinavir SGC patients may have the option to change to this optimal dose in a treatment extension phase of the protocol Patients in this extension phase may choose to remain on monotherapy unless they experience significant drug toxicity their CD4 count or HIV-RNA levels return to baseline until saquinavir is approved by the FDA or study termination whichever comes first
NOTE A washout 28 days is required for patients on antiretroviral therapy
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 |
|---|---|---|---|
| NV15107 | None | None | None |