Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002397
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Saquinavir Soft Gel Capsules SGC Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Exploratory Study of Fortovase Saquinavir Soft Gelatin Capsules SGC Plus d4T and 3TC or Fortovase Saquinavir SGC Plus Nelfinavir and d4T in Patients With HIV-1 Associated Nephropathy
Status:
COMPLETED
Status Verified Date:
1998-12
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:
The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine d4T plus lamivudine 3TC with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening This study also examines the effect these drug combinations have on the level of HIV detected in these patients Finally this study evaluates the drug level the amount of drug found in the body of these two combinations in patients with kidney disease
Detailed Description:
This is an open-label non-comparative randomized single center 24-week study Patients are stratified into 3 groups 8 patients in each group based on kidney function
Group 1 Serum creatine less than 2 mgdL Group 2 Serum creatine 2-5 mgdL Group 3 Serum creatine greater than 5 mgdL
All 24 patients are randomized 11 to receive 1 of 2 study regimens
Arm A Saquinavir SGC plus d4T plus 3TC Arm B Saquinavir SGC plus nelfinavir plus d4T Patients are seen at Weeks 4 8 12 and 24 At Week 24 a kidney biopsy is performed with patient consent
Group 1 Serum creatine less than 2 mgdL Group 2 Serum creatine 2-5 mgdL Group 3 Serum creatine greater than 5 mgdL
All 24 patients are randomized 11 to receive 1 of 2 study regimens
Arm A Saquinavir SGC plus d4T plus 3TC Arm B Saquinavir SGC plus nelfinavir plus d4T Patients are seen at Weeks 4 8 12 and 24 At Week 24 a kidney biopsy is performed with patient consent
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 |
|---|---|---|---|
| NR15690M61021 | None | None | None |