Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344760
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2006-06-23
Brief Title:
A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV
Status:
COMPLETED
Status Verified Date:
2021-05
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:
We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells and lower number of minority variant HIV-1 strains
Detailed Description:
This is an 48 week Phase 4 open label randomized prospective pilot proof of concept study to evaluate the use of Enfuvirtide in an inductionmaintenance treatment model Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads less than 300000 copiesml and greater than 300000 copiesml Thereafter patients will be block randomized the size of each block will be two patients into one of two treatment arms
All patients will receive Efavirenz 600mg once a day Lamivudine 300 mg once a day and Tenofovir 300mg once a day After randomization one half of the patients will receive no additional treatment while the other half will receive Enfuvirtide 90mg sq BID until the viral load is 50 x 2 consecutive visits or 12 weeks whichever comes first
All patients will receive Efavirenz 600mg once a day Lamivudine 300 mg once a day and Tenofovir 300mg once a day After randomization one half of the patients will receive no additional treatment while the other half will receive Enfuvirtide 90mg sq BID until the viral load is 50 x 2 consecutive visits or 12 weeks whichever comes first
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