Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002382
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Saquinavir Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open Label International Compassionate Treatment Program for the Use of Saquinavir R0 31-8959 Either As Monotherapy or in Combination With Other Anti-Retroviral Drugs in Patients With Proven HIV Infection
Status:
COMPLETED
Status Verified Date:
1997-06
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 offer an investigational agent saquinavir to people with HIVAIDS who are in need of additional treatment options and are not eligible to enroll in ongoing clinical trials
Patients who no longer benefit from existing antiretroviral therapy and who are not currently enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program
Patients who no longer benefit from existing antiretroviral therapy and who are not currently enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program
Detailed Description:
Patients who no longer benefit from existing antiretroviral therapy and who are not currently enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program
Patients may be registered with the program through their physicians who will be responsible for supervising the administration of treatment following guidelines for saquinavir dose interruption dose reduction or discontinuation and assessing patient progress throughout the duration of the study Access to saquinavir will be determined by a lottery system 60 percent of the program slots will be reserved for patients with CD4 counts of 50 or less and the remaining 40 percent of the slots will be devoted to patients with CD4 counts between 51 and 300
Patients may be registered with the program through their physicians who will be responsible for supervising the administration of treatment following guidelines for saquinavir dose interruption dose reduction or discontinuation and assessing patient progress throughout the duration of the study Access to saquinavir will be determined by a lottery system 60 percent of the program slots will be reserved for patients with CD4 counts of 50 or less and the remaining 40 percent of the slots will be devoted to patients with CD4 counts between 51 and 300
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 |
|---|---|---|---|
| SV14974 | None | None | None |