Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071890
Status:
COMPLETED
Last Update Posted:
2010-10-05
First Post:
2003-11-03
Brief Title:
Phase IIIII Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cellsmm3 Who Received Antiretroviral Tx
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase IIIII Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Anti-Retroviral TX in HIV Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cellsmm3 Who Have Received Anti-Retroviral TX
Status:
COMPLETED
Status Verified Date:
2010-09
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:
ILIADE
Brief Summary:
This study will examine whether interleukin-2 IL-2 given before the interruption of antiretroviral ARV treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter There will be an evaluation of the toxicity or extremely harmful effects of ARV and the effect on quality of life
The use of ARV medications has greatly improved the condition and mortality of HIV-infected patients But when used long term those medications have been associated with great toxicities and medication fatigue As a result patients may not adhere to ARV use and resistance to viruses may grow The CD4 molecule is on the surface of helper T-lymphocytes or T-helper cells It serves as the primary receptor for HIV-1 and HIV-2 allowing the virus to gain entry into its host The CD4 count increases immediately in response to ARV giving an estimate of the state of a patients immune system Thus it is a strong marker of the immediate risk of an opportunistic infection one that takes advantage of a persons weakened immune system IL-2 is a molecule naturally produced by activated T cells In patients with HIV IL-2 treatment can increase CD4 counts but the clinical importance of this increase is not clear This study will compare the decline in CD4 count when ARV is interrupted in two random groups of participants 1 those who will receive three cycles of IL-2 one every 8 weeks in combination with ARV therapy for the first 24 weeks of the study before stopping ARV and 2 those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV
Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy for at least 1 year and who currently have a CD4 count 500 cells per microliter or higher and never had a CD4 count of less than 200 cells per microliter and a viral load less than the limit of detection may be eligible for this study
Participants will undergo the following procedures and tests
Physical examination
Blood tests to measure blood lipids fats sugar complete blood count including platelets and chemistries
Assessment of fat distribution
Questionnaire about quality of life
In addition those participants who are randomly placed in the group receiving IL-2 and ARV will get an echocardiogram at the beginning of the study and at week 24 They will receive a starting dose of 6 million units of IL-2 as an injection under the skin twice a day Each of the three IL-2 cycles will last 5 days After the 24-week period participants in both groups will stop taking ARV medications if their CD4 count is still equal to or greater than 500 cells per microliter The study will continue into 120 weeks Participants will be asked to continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts Every 24 weeks they will be asked to answer a questionnaire about their quality of life Blood tests and other measurements will also be done as follow-up
The use of ARV medications has greatly improved the condition and mortality of HIV-infected patients But when used long term those medications have been associated with great toxicities and medication fatigue As a result patients may not adhere to ARV use and resistance to viruses may grow The CD4 molecule is on the surface of helper T-lymphocytes or T-helper cells It serves as the primary receptor for HIV-1 and HIV-2 allowing the virus to gain entry into its host The CD4 count increases immediately in response to ARV giving an estimate of the state of a patients immune system Thus it is a strong marker of the immediate risk of an opportunistic infection one that takes advantage of a persons weakened immune system IL-2 is a molecule naturally produced by activated T cells In patients with HIV IL-2 treatment can increase CD4 counts but the clinical importance of this increase is not clear This study will compare the decline in CD4 count when ARV is interrupted in two random groups of participants 1 those who will receive three cycles of IL-2 one every 8 weeks in combination with ARV therapy for the first 24 weeks of the study before stopping ARV and 2 those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV
Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy for at least 1 year and who currently have a CD4 count 500 cells per microliter or higher and never had a CD4 count of less than 200 cells per microliter and a viral load less than the limit of detection may be eligible for this study
Participants will undergo the following procedures and tests
Physical examination
Blood tests to measure blood lipids fats sugar complete blood count including platelets and chemistries
Assessment of fat distribution
Questionnaire about quality of life
In addition those participants who are randomly placed in the group receiving IL-2 and ARV will get an echocardiogram at the beginning of the study and at week 24 They will receive a starting dose of 6 million units of IL-2 as an injection under the skin twice a day Each of the three IL-2 cycles will last 5 days After the 24-week period participants in both groups will stop taking ARV medications if their CD4 count is still equal to or greater than 500 cells per microliter The study will continue into 120 weeks Participants will be asked to continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts Every 24 weeks they will be asked to answer a questionnaire about their quality of life Blood tests and other measurements will also be done as follow-up
Detailed Description:
The use of antiretroviral ARV medications has greatly improved morbidity and mortality of HIV-infected patients but long-term use of these agents has been associated with significant toxicities and medication fatigue that can lead to problems with adherence and eventual development of virologic resistance The spectrum of ARV toxicities is broad including the development of lipodystrophy syndrome with lipid abnormalities and glucose intolerance or diabetes while increasing evidence suggests an increased risk of cardiovascular complications in ARV-treated HIV-infected individuals Current PHHS treatment guidelines recommend deferring ARV treatment initiation in asymptomatic HIV-infected individuals with CD4 count greater than or equal to 350 cellsmicro liter and treatment initiation after the CD4 count is less than 350 cellsmicro liter Several patients who started antiretroviral therapy at higher CD4 counts based on older treatment initiation guidelines or have experienced significant immunologic reconstitution after ARV initiation elect to interrupt antiretroviral therapy until their CD4 count reaches the level of current recommendations for therapy initiation less than 350 cellsmicro liter
Studies to date suggest that baseline and nadir CD4 count are the best predictors of a longer duration of treatment interruption that may be more beneficial with respect to reversal or delay of long-term ARV-associated toxicity and improved quality of life It is known that intermittent cycles of IL-2 administration can lead to expansion of the CD4 pool and prolong survival of CD4 T cells In this study the hypothesis tested is that IL-2 given prior to ARV treatment interruption could significantly prolong the period of ARV treatment interruption with preservation of CD4 counts above 350 cellsmicro liter and that this prolongation will be beneficial with respect to antiretroviral related toxicity and quality of life
The study will have two parts during the first part 24 weeks patients will be randomized 11 to either receive three cycles or IL-2 with their ARV therapy or ARV therapy alone In the second part week 24 to week 120 all participants will interrupt therapy and restart when CD4 is less than 350 cellsmicro liter The main comparison will be at week 72 when the proportion of patients from the two groups who remain off drugs and have a CD4 greater than 350 cellsmicro liter will be compared At regular intervals every 24 weeks lipodystrophy measurements and quality of life questionnaires will be evaluated
Studies to date suggest that baseline and nadir CD4 count are the best predictors of a longer duration of treatment interruption that may be more beneficial with respect to reversal or delay of long-term ARV-associated toxicity and improved quality of life It is known that intermittent cycles of IL-2 administration can lead to expansion of the CD4 pool and prolong survival of CD4 T cells In this study the hypothesis tested is that IL-2 given prior to ARV treatment interruption could significantly prolong the period of ARV treatment interruption with preservation of CD4 counts above 350 cellsmicro liter and that this prolongation will be beneficial with respect to antiretroviral related toxicity and quality of life
The study will have two parts during the first part 24 weeks patients will be randomized 11 to either receive three cycles or IL-2 with their ARV therapy or ARV therapy alone In the second part week 24 to week 120 all participants will interrupt therapy and restart when CD4 is less than 350 cellsmicro liter The main comparison will be at week 72 when the proportion of patients from the two groups who remain off drugs and have a CD4 greater than 350 cellsmicro liter will be compared At regular intervals every 24 weeks lipodystrophy measurements and quality of life questionnaires will be evaluated
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 118 ILIADE | OTHER | ANRS | None |
| 04-I-0018 | OTHER | None | None |