Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120185
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-07-08
Brief Title:
Efficacy of Using Interleukin-2 in Antiretroviral Naïve HIV Patients ANRS119
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:
Study of the Immunological Efficacy of Using Subcutaneous Interleukin-2 IL-2 in Antiretroviral Naïve HIV-1-Infected Subjects With a CD4 Cell Count Above 300mm3 ANRS 119 Trial INTERSTART
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:
Interleukin-2 IL-2 increases the number of CD4 cells in HIV-1 infected patients under highly active antiretroviral therapy HAART with a CD4 cell count over 200mm3 but its activity in patients without antiretroviral therapy is unknown This study will test the efficacy and safety of IL-2 in naïve patients with a CD4 count between 300 and 500m3
Detailed Description:
IL-2 is produced naturally in the body and helps CD4 cells multiply In earlier studies in HIV-infection most of the patients with a controlled viral load under antiretroviral therapy and a high level of CD4 cell count over 200mm3 who received IL-2 experienced an increase of their CD4 cell count superior to what is observed with antiretroviral therapy alone The efficacy of IL-2 when the viral load is high and the patient is not receiving antiretroviral therapy is not known The purpose of this multicentric national study is to compare the effects of IL-2 versus no treatment in HIV naïve patients One hundred thirty HIV-1-infected patients with a CD4 count between 300 and 500mm3 will be randomly assigned to one of two treatment groups IL-2 or no treatment The group with IL-2 will receive a dose of 45 million international units by subcutaneous injection twice a day for 5 days up to a total of 5 cycles ending at Week 96 the first three cycles 8 weeks apart Evaluation will be done at week 96 The primary endpoint is the proportion of patients reaching an absolute CD4 count below 300mm3 at Week 96 Secondary endpoints include the occurrence of HIV-related events drug safety and the evolution of CD4 cells and of HIV RNA and HIV DNA loads over time
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 |
|---|---|---|---|
| ANRS119 Interstart | None | None | None |