Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002239
Status:
COMPLETED
Last Update Posted:
2005-11-15
First Post:
1999-11-02
Brief Title:
A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir Amprenavir Ritonavir and Efavirenz to HIV-Infected Adults
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir Amprenavir Ritonavir and Efavirenz in HIV-1 Infected Adults
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if it is safe and effective to give T-20 a new type of anti-HIV drug with a combination of other anti-HIV drugs The other anti-HIV drugs used are abacavir ABC amprenavir APV ritonavir RTV and efavirenz EFV Three different doses of T-20 are tested
Detailed Description:
Patients are assigned to one of four groups Three dose groups receive a background antiretroviral regimen ABC APV RTV and EFV and T-20 which is given at one of three doses on a twice-daily regimen The fourth group control receives the background antiretroviral regimen alone For each treatment group 17 patients are enrolled Treatment is administered for 16 weeks followed by a 32-week treatment extension and a 2-week follow-up period The following are assessed throughout the trial safety parameters as measured by hematology clinical chemistry urinalysis and treatment-emergent adverse events virologic and immunologic activity phenotypic and genotypic resistance T-20 plasma levels and pharmacokinetics of T-20 and oral antiretrovirals The total study duration is 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 295B | None | None | None |