Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454337
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2007-03-29
Brief Title:
Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Randomized Non-inferiority Study Comparing a Strategy Maintaining Current Enfuvirtide-based Antiretroviral Therapy to a Strategy Replacing Enfuvirtide by an Integrase Inhibitor Raltegravir in HIV-1 Infected Subjects With Plasma Hiv-1 RNA Levels Below 400 Copies Per mlANRS 138 EASIER
Status:
COMPLETED
Status Verified Date:
2012-11
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:
EASIER
Brief Summary:
Switching from enfuvirtide to raltegravir in the treatment of HIV-infected patients who sustain viral suppression with a combination therapy including enfuvirtide or with an enfuvirtide-based combination therapy
Detailed Description:
In patients who have failed under the three main classes of antiretroviral agents NRTI NNRTI and PI and in whom the control of viral replication in the plasma has ultimately been achieved with enfuvirtide the aim is to sustain this virological success for as long as possible to thus enable satisfactory immune reconstitution avoid further accumulation of viral mutations conferring resistance to the drugs and protect the patient from the risk of opportunistic disease and death
Indeed enfuvirtide is the lead compound in the new class of antiretroviral drugs which inhibit the fusion of HIV-1 virus with its target cell Its in vivo efficacy was demonstrated during the pivotal studies TORO 1 and 2 Despite its efficacy maintaining long-term treatment with enfuvirtide is nonetheless difficult for patients because of the constraints related to twice-daily subcutaneous parenteral injections Furthermore these subcutaneous injections are associated with inflammatory reactions at the injection site in 98 per cent of patients without any reduction in frequency or severity over time It is thus critical for patients who are well controlled by enfuvirtide to be able to simplify their treatment by replacing enfuvirtide with another active compound taken by mouth which would enable maintenance of the virological response and acceptable safety in patients who have usually failed under the three main classes of antiretroviral drugs A new antiviral compound viral integrase inhibitor called raltegravir could be proposed instead of enfuvirtide
Indeed enfuvirtide is the lead compound in the new class of antiretroviral drugs which inhibit the fusion of HIV-1 virus with its target cell Its in vivo efficacy was demonstrated during the pivotal studies TORO 1 and 2 Despite its efficacy maintaining long-term treatment with enfuvirtide is nonetheless difficult for patients because of the constraints related to twice-daily subcutaneous parenteral injections Furthermore these subcutaneous injections are associated with inflammatory reactions at the injection site in 98 per cent of patients without any reduction in frequency or severity over time It is thus critical for patients who are well controlled by enfuvirtide to be able to simplify their treatment by replacing enfuvirtide with another active compound taken by mouth which would enable maintenance of the virological response and acceptable safety in patients who have usually failed under the three main classes of antiretroviral drugs A new antiviral compound viral integrase inhibitor called raltegravir could be proposed instead of enfuvirtide
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 |
|---|---|---|---|
| ANRS 138 EASIER | None | None | None |