Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120367
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-07-11
Brief Title:
Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy ANRS125
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Early Intensification of Combination Antiretroviral Therapy Including FUZEON in the Treatment of Progressive Multifocal Leucoencephalopathy During HIV-1 Infection ANRS 125 Trial
Status:
COMPLETED
Status Verified Date:
2011-12
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:
Progressive multifocal leucoencephalopathy PML is a rare infectious disease of the brain provoked by the JC virus It usually occurs in subjects with impaired immune system as during HIV infection To date there is no specific antiviral treatment susceptible to cure PML But it was shown in the setting of HIV-related PML that combination antiretroviral therapy allows a restoration of the immune system and then might stop the progression of PML
The objective of this study is to appreciate the supplementary efficiency brought by an association of more powerful antiretroviral molecules including enfuvirtide on the evolution of PML This research program will involve 30 patients in several centres in France All the patients who will participate will receive enfuvirtide during 6 months in association with a combination of two or more potent antiretroviral drugs The total duration of follow-up for a patient will be of 1 year
The objective of this study is to appreciate the supplementary efficiency brought by an association of more powerful antiretroviral molecules including enfuvirtide on the evolution of PML This research program will involve 30 patients in several centres in France All the patients who will participate will receive enfuvirtide during 6 months in association with a combination of two or more potent antiretroviral drugs The total duration of follow-up for a patient will be of 1 year
Detailed Description:
The aim of this open-label multicentre study is to estimate the effect of an early therapy intensification based on potent antiretroviral combination including enfuvirtideFUZEON on survival in patients with HIV-1-related progressive multifocal leucoencephalopathy PML
To demonstrate that the observed rate is significantly superior to 45 the inclusion of 24 patients is necessary At last 30 patients will be recruited towards the risk estimated at 25 of invalid inclusion
Patients will be included on the following criteria HIV-1 documented by Western Blot clinical and radiological MRI evidence of active LEMP with clinical evolution or deterioration for less than 90 days documentation of PML diagnosis for less than 30 days at the inclusion informed consent patient or confidence surrogate if decision making incapacity Exclusion criteria will be the following age less than 18-year-old concomitant opportunistic infection of the central nervous system pregnancy - feeding co-infection by the HIV2 history of immunotherapy interleukin 2 alpha-interferon or of treatment by FUZEON history of treatment by cidofovir contra-indication to receive FUZEON
An independent committee will meet regularly to estimate the validity of PML diagnosis in included patients
The duration of the treatment by FUZEON is 6 months in association with a combination of two or more antiretroviral molecules which will be pursued during the next 6 months These molecules will be chosen according to the past treatment of the patients A combination including efavirenz lopinavirritonavir and tenofoviremtricitabine under the shape of TRUVADA will be proposed to the naïve patients For the pretreated patientapproximately a quarter of the inclusions antiretroviral therapy will be chosen in every case on the basis of the therapeutic history and of the viral genotypes of resistance Such association will contain at least two antiretroviral molecules issued from two different families among the three following ones nucleoside inhibitors of the reverse transcriptase non-nucleoside inhibitors of the reverse transcriptase protease inhibitors
The projected duration of the period of inclusion will be 18 months A total duration of 25 years is projected
Evaluation criteria of the ANRS 125 trial are the following Clinical rate of survival and functional score Modified Rankin Outcome Scale to M12 Virological evolution of the JC viral load in the CSF and percentage of patients with JC virus clearance of the CSF to M3 and M6 Immunological evolution of T CD4 and T CD8 subpopulations Evolution of the anti-JC virus specific T cell CD4 and CD8 responses Pharmacological dosage of the concentration of enfuvirtide in the CSF compared with the plasma
To demonstrate that the observed rate is significantly superior to 45 the inclusion of 24 patients is necessary At last 30 patients will be recruited towards the risk estimated at 25 of invalid inclusion
Patients will be included on the following criteria HIV-1 documented by Western Blot clinical and radiological MRI evidence of active LEMP with clinical evolution or deterioration for less than 90 days documentation of PML diagnosis for less than 30 days at the inclusion informed consent patient or confidence surrogate if decision making incapacity Exclusion criteria will be the following age less than 18-year-old concomitant opportunistic infection of the central nervous system pregnancy - feeding co-infection by the HIV2 history of immunotherapy interleukin 2 alpha-interferon or of treatment by FUZEON history of treatment by cidofovir contra-indication to receive FUZEON
An independent committee will meet regularly to estimate the validity of PML diagnosis in included patients
The duration of the treatment by FUZEON is 6 months in association with a combination of two or more antiretroviral molecules which will be pursued during the next 6 months These molecules will be chosen according to the past treatment of the patients A combination including efavirenz lopinavirritonavir and tenofoviremtricitabine under the shape of TRUVADA will be proposed to the naïve patients For the pretreated patientapproximately a quarter of the inclusions antiretroviral therapy will be chosen in every case on the basis of the therapeutic history and of the viral genotypes of resistance Such association will contain at least two antiretroviral molecules issued from two different families among the three following ones nucleoside inhibitors of the reverse transcriptase non-nucleoside inhibitors of the reverse transcriptase protease inhibitors
The projected duration of the period of inclusion will be 18 months A total duration of 25 years is projected
Evaluation criteria of the ANRS 125 trial are the following Clinical rate of survival and functional score Modified Rankin Outcome Scale to M12 Virological evolution of the JC viral load in the CSF and percentage of patients with JC virus clearance of the CSF to M3 and M6 Immunological evolution of T CD4 and T CD8 subpopulations Evolution of the anti-JC virus specific T cell CD4 and CD8 responses Pharmacological dosage of the concentration of enfuvirtide in the CSF compared with the plasma
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 125 | None | None | None |