Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487188
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2007-06-14
Brief Title:
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy HAART in Human Immunodeficiency Virus HIV Patients With Prior Treatment Experience
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Phase IIIbIV Randomized Controlled Study Evaluating an Intensification Treatment Strategy of Adding Enfuvirtide ENF to an Oral Highly Active AntiRetroviral Therapy HAART in Treatment Experienced Patients
Status:
COMPLETED
Status Verified Date:
2015-07
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:
INTENSE
Brief Summary:
To assess the efficacy of enfuvirtide Fuzeon added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression
Detailed Description:
This study consisted of two phases In the Induction phase patients were randomized at Baseline 1 BL1 in a 12 ratio to receive
I1 HAART or
I2 Enfuvirtide 90 mg twice a day HAART
Participants who achieved viral suppression 50 copiesmL by week 24 confirmed by week 28 or earlier qualified to enter the Maintenance Phase which started at Baseline 2 BL2 four weeks after confirmation of response The Maintenance Phase consisted of three treatment groups
M1 HAART continued patients from I1
Patients on ENFHAART I2 were re-randomized at a 11 ratio at BL2 to
M2 Enfuvirtide stopped and HAART continued
M3 Enfuvirtide HAART continued
The duration of the Maintenance Phase was from BL2 up to 48 weeks after BL1 BL2 could start at the earliest at Week 12 and at the latest Week 32
I1 HAART or
I2 Enfuvirtide 90 mg twice a day HAART
Participants who achieved viral suppression 50 copiesmL by week 24 confirmed by week 28 or earlier qualified to enter the Maintenance Phase which started at Baseline 2 BL2 four weeks after confirmation of response The Maintenance Phase consisted of three treatment groups
M1 HAART continued patients from I1
Patients on ENFHAART I2 were re-randomized at a 11 ratio at BL2 to
M2 Enfuvirtide stopped and HAART continued
M3 Enfuvirtide HAART continued
The duration of the Maintenance Phase was from BL2 up to 48 weeks after BL1 BL2 could start at the earliest at Week 12 and at the latest Week 32
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