Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008528
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-01-12
Brief Title:
T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment andor Drug Resistance to Each of the Three Classes of Approved 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 Therapy 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:
2001-06
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:
The purpose of this study is to compare the change in viral load amount of HIV in the blood of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs
Detailed Description:
Eligible patients remain on their pre-study regimen until baseline An OB regimen is chosen by the physician and patient based on the patients prior treatment history prior and current laboratory abnormalities the screening GTPT antiretroviral resistance testing and any prior GTPT antiretroviral resistance if available The drugs in the OB regimen are chosen from among the currently approved antiretrovirals and permitted newly approvedinvestigational antiretrovirals available in the countries where the study is implemented and must consist of 3 to 5 drugs including no more than 1 newly approvedinvestigational agent Patients are stratified with respect to viral load and use versus non-use of any of the allowed newly approvedinvestigational antiretrovirals Patients are randomized to receive 1 of the following 2 treatments for 48 weeks OB or OB plus T-20 Patients are followed to assess viral load safety antiretroviral resistance T-20 pharmacokinetics and quality of life At the end of 48 weeks of treatment patients are allowed to a roll over and receive OB plus T-20 for patients receiving OB regimen alone or b continue taking OB plus T-20 for patients already receiving OB plus T-20 for 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 in this study 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 |
|---|---|---|---|
| T20-301 | None | None | None |