Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002374
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IIIB Open-Label Trial Replacing Saquinavir HGC Ro 31-8959 With Saquinavir SGC Ro 31-8959 in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection
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 examine the efficacy of saquinavir SGC soft gel capsules in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC hard gel capsules measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment
Detailed Description:
Eligible patients will be stratified by HIV-1 RNA level into 2 populations 1 5000-30000 HIV-1 RNA 2 30000 HIV-1 RNA All patients will be randomized to 1 of 3 treatment arms Arm A - Saquinavir soft gel capsules SQV SGC 2 new nucleoside analogs reverse transcriptase inhibitors RTIs Arm B - SQV SGC nelfinavir stavudine d4T or a new RTI or Arm C - SQV SGC ritonavir d4T or a new RTI All patients will undergo plasma HIV-1 RNA determinations CD4 lymphocyte counts hematology and chemistry blood work at baseline weeks 4 8 12 16 and 24
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 |
|---|---|---|---|
| NR15521 | None | None | None |