Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002378
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Phase IIIB Comparative Study to Evaluate Saquinavir Soft Gel Capsule SGC TID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule SGC BID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule SGC BID Plus Nelfinavir BID Plus a NRTI in HIV-1 Infected Patients
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:
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection 400 copiesml at week 24 of study therapy To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment To collect safety data on the treatment regimens
AS PER AMENDMENT 121297 To compare the virologic response of Fortovase FTV Saquinavir Soft Gel Capsule SGC tid plus nucleoside reverse transcriptase inhibitors NRTIs versus FTV bid plus NRTIs Further to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection 400 copiesml at week 24 and week 48
AS PER AMENDMENT 121297 To compare the virologic response of Fortovase FTV Saquinavir Soft Gel Capsule SGC tid plus nucleoside reverse transcriptase inhibitors NRTIs versus FTV bid plus NRTIs Further to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection 400 copiesml at week 24 and week 48
Detailed Description:
Patients will be randomized to receive 1 of 3 study regimens Group A - Saquinavir SQV sgc plus 2 new reverse transcriptase inhibitors RTIs Group B - SQV sgc plus delavirdine plus new RTI and Group C - SQV sgc plus nelfinavir plus new RTI or SQV sgc plus ritonavir plus 2 new RTIs
NOTE New RTI is defined for this study as any reverse transcriptase inhibitor to which the patient has never been exposed
AS PER AMENDMENT 121297 In this open-label multicenter Phase IIIB comparative study 825 patients are randomized to treatment arms NOTE 50 of the patients will be treatment naive and 50 will be NRTI experienced Further patients are randomized with stratification based on HIV-1 RNA level 5000-30000 copiesml vs greater than 30000 copiesml and prior antiretroviral therapy to one of the three study arms
The drug regimens for the three treatment arms are as follows
ARM A Fortovase FTV plus 2 new NRTIs ARM B FTV plus 2 new NRTIs ARM C FTV plus nelfinavir plus new NRTI
Naive patients in Arm A and Arm B will take d4T or zidovudine plus 3TC unless contraindicated
Naive patients in Arm C will take d4T unless contraindicated
NRTI experienced patients in Arms A B should be treated with 2 NRTIs to which heshe has not been previously exposed If the patient has only 1 NRTI to which heshe has never been exposed then the second NRTI can be one that the patient has been previously exposed to from the most distant past
Therapy is administered for an initial 24 weeks and may be extended for an additional 24 weeks
NOTE New RTI is defined for this study as any reverse transcriptase inhibitor to which the patient has never been exposed
AS PER AMENDMENT 121297 In this open-label multicenter Phase IIIB comparative study 825 patients are randomized to treatment arms NOTE 50 of the patients will be treatment naive and 50 will be NRTI experienced Further patients are randomized with stratification based on HIV-1 RNA level 5000-30000 copiesml vs greater than 30000 copiesml and prior antiretroviral therapy to one of the three study arms
The drug regimens for the three treatment arms are as follows
ARM A Fortovase FTV plus 2 new NRTIs ARM B FTV plus 2 new NRTIs ARM C FTV plus nelfinavir plus new NRTI
Naive patients in Arm A and Arm B will take d4T or zidovudine plus 3TC unless contraindicated
Naive patients in Arm C will take d4T unless contraindicated
NRTI experienced patients in Arms A B should be treated with 2 NRTIs to which heshe has not been previously exposed If the patient has only 1 NRTI to which heshe has never been exposed then the second NRTI can be one that the patient has been previously exposed to from the most distant past
Therapy is administered for an initial 24 weeks and may be extended for an additional 24 weeks
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 |
|---|---|---|---|
| M6101 | None | None | None |
| NR15520 | None | None | None |