Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021554
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-07-21
Brief Title:
T-20 in HIV Patients With Prior Drug Treatment andor Resistance to Each of the Three Classes of Anti-HIV Drugs
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Open-Label Randomized Active-Controlled Study Assessing the Efficacy and Safety of T-20 HIV-1 Fusion Inhibitor in Combination With an Optimized Background Regimen Versus Optimized Background Regimen Alone in Patients With Prior Experience andor Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals Nucleoside Reverse Transcriptase Non-Nucleoside Reverse Transcriptase and Protease Inhibitors
Status:
COMPLETED
Status Verified Date:
2002-05
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 show if a dose of T-20 added to an anti-HIV combination chosen specifically for each patient lowers viral load by at least a certain level after 24 weeks as compared to an anti-HIV combination chosen specifically for each patient alone Another purpose is to show if the patient response to T-20 will be maintained for 48 weeks
Detailed Description:
An OB regimen is selected to be initiated at baseline by the physician and patient The OB regimen is based on the patients prior treatment history as well as the results from the first screening visit HIV-1 genotypic and phenotypic GT and PT resistance testing and prior GTPT antiretroviral resistance testing if available Prior or current laboratory abnormalities including triglycerides and cholesterol should also be taken into account when selecting the OB regimen Patients are stratified with respect to the following 1 screening viral load less than 40000 or 40000 or more copiesml and 2 number of allowed investigational antiretrovirals 0 1 or 2 Patients then are randomized to receive 1 of the following treatments for 48 weeks OB regimen or OB plus T-20 regimen Patients are seen for evaluation of efficacy and safety at Weeks 1 2 and 4 every 4 weeks through Week 24 and then every 8 weeks through Week 48 In addition efficacy only is evaluated at Weeks 6 10 and 14 Patients also may be seen at additional visits during the study for plasma HIV-1 RNA measurements to potentially confirm virological failure
Patients initially randomized to the OB arm who meet the criteria for virological failure and who switch to OB plus T-20 after Week 8 are followed under a new switch schedule of assessments Patients are encouraged to change their OB regimen at the time of switch
Patients initially randomized to the OB plus T-20 arm who meet the criteria for virological failure may continue to receive OB plus T-20 if the patient and the physician feel that there is sufficient benefit Patients are encouraged to change their OB regimen after Week 8 if they choose to continue on OB plus T-20 despite meeting the criteria for virological failure
Patients on OB or OB plus T-20 arm who meet the criteria for virological failure but who do not wish to either switch to T-20 for patients initially randomized to OB arm or continue with T-20 for patients initially randomized to OB plus T-20 are allowed to remain in the study for a maximum of 1 month
At the end of the 48 weeks of treatment patients are allowed to participate in 1 of the following treatment extensions a roll-over and receive OB plus T-20 for patients receiving OB alone or b continue taking OB plus T-20 for patients already receiving OB plus T-20 for a maximum of an additional 48 weeks plus 4 weeks safety follow-up period or until 12 weeks after commercial availability of T-20 in the country in which they are treated whichever comes first All patients are followed for a maximum of 100 weeks from their initial baseline visit date
Patients initially randomized to the OB arm who meet the criteria for virological failure and who switch to OB plus T-20 after Week 8 are followed under a new switch schedule of assessments Patients are encouraged to change their OB regimen at the time of switch
Patients initially randomized to the OB plus T-20 arm who meet the criteria for virological failure may continue to receive OB plus T-20 if the patient and the physician feel that there is sufficient benefit Patients are encouraged to change their OB regimen after Week 8 if they choose to continue on OB plus T-20 despite meeting the criteria for virological failure
Patients on OB or OB plus T-20 arm who meet the criteria for virological failure but who do not wish to either switch to T-20 for patients initially randomized to OB arm or continue with T-20 for patients initially randomized to OB plus T-20 are allowed to remain in the study for a maximum of 1 month
At the end of the 48 weeks of treatment patients are allowed to participate in 1 of the following treatment extensions a roll-over and receive OB plus T-20 for patients receiving OB alone or b continue taking OB plus T-20 for patients already receiving OB plus T-20 for a maximum of an additional 48 weeks plus 4 weeks safety follow-up period or until 12 weeks after commercial availability of T-20 in the country in which they are treated whichever comes first All patients are followed for a maximum of 100 weeks from their initial baseline visit date
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 |
|---|---|---|---|
| T20-302 | None | None | None |