Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302822
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2006-03-14
Brief Title:
Intensification With Enfuvirtide in Naive HIV-infected Patients ANRS130
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Enfuvirtide for the Initial Phase of Antiretroviral Therapy in HIV-infected Patients With High Risk of Clinical Progression ANRS 130 APOLLO
Status:
COMPLETED
Status Verified Date:
2013-07
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:
None
Brief Summary:
HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression AIDS new AIDS-defining event or death The currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated Enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent regarding its activity its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment the lack of pharmacokinetic interactions and the absence of systemic toxicity
The aim of this study is to investigate in a comparative intensification trial the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients naïve of any antiretroviral treatment
We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabinetenofovir combined with either efavirenz or lopinavirr may improve immunological restoration measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy
The aim of this study is to investigate in a comparative intensification trial the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients naïve of any antiretroviral treatment
We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabinetenofovir combined with either efavirenz or lopinavirr may improve immunological restoration measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy
Detailed Description:
The purpose of this randomized open-label study is to evaluate the immunological efficacy of two first-line strategies of antiretroviral therapy
1 emtricitabinetenofovir disoproxil fumarate coformulated plus efavirenz or lopinavirr intensified by enfuvirtide during the first 24 weeks of therapy
2 emtricitabinetenofovir disoproxil fumarate coformulated plus efavirenz or lopinavirr
Patients with lymphocytes T CD4 cell CD4count below 100 per mm3 or CD4 cell count below 200 per mm3 and past history or presence of AIDS defining event and naïve of any antiretroviral therapy will be eligible This multicenter study will enroll 220 patients n110 in each arm The planned duration of the study is 48 weeks from the enrolment of the last subject
The primary endpoint will be immunological success defined as CD4 cell count above 200 cells per mm3 after 24 weeks of initial treatment The durability of this response will be evaluated and patients will be followed for 48 weeks
1 emtricitabinetenofovir disoproxil fumarate coformulated plus efavirenz or lopinavirr intensified by enfuvirtide during the first 24 weeks of therapy
2 emtricitabinetenofovir disoproxil fumarate coformulated plus efavirenz or lopinavirr
Patients with lymphocytes T CD4 cell CD4count below 100 per mm3 or CD4 cell count below 200 per mm3 and past history or presence of AIDS defining event and naïve of any antiretroviral therapy will be eligible This multicenter study will enroll 220 patients n110 in each arm The planned duration of the study is 48 weeks from the enrolment of the last subject
The primary endpoint will be immunological success defined as CD4 cell count above 200 cells per mm3 after 24 weeks of initial treatment The durability of this response will be evaluated and patients will be followed for 48 weeks
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 |
|---|---|---|---|
| 2005-004722-12 | EUDRACT_NUMBER | None | None |