Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477321
Status:
COMPLETED
Last Update Posted:
2012-10-18
First Post:
2007-05-22
Brief Title:
Safety Study of IL-7 in HIV-infected Patients Inspire
Sponsor:
Cytheris SA
Organization:
Cytheris SA
Study Overview
Official Title:
A Ph IIIa Rand Placebo Ctrl S-Blind Multictr Dose-Esc Study of SC Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Pts With CD4 T Lymphocyte Counts 101-400 Cells-mm3 and Plasma HIV RNA Less Than 50 CopiesmL After at Least 12 M of HAART
Status:
COMPLETED
Status Verified Date:
2012-10
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:
This study will evaluate the safety of a new experimental drug IL-7 in people with HIV infection Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes or T cells If this study shows that IL-7 is safe additional studies will be done to see if it can improve the function or numbers of T-cells in HIV-infected persons
HIV-infected persons who have been receiving HAART therapy for at least 12 months before enrolling in the study and have been stable on this treatment for at least 3 months before enrollment may be eligible for this study
Participants have about 10 clinic visits over 3 months They receive three injections of IL-7 one injection a week for 3 consecutive weeks The injections are given as a shot under the skin in the arm or leg On the day of each injection the participant stays in the clinic for up to 8 hours or longer for observation and collection of blood samples Three additional visits one every 3 months may be scheduled
During the study visits the following may be done
Medical history physical examination blood tests every visit
Electrocardiogram EKG at study days 0 day of first dose 1 7 day of second dose 14 day of third dose and 21
Chest x-ray study on day 21
Blood sample collections at frequent intervals during the first 96 hours after the first dose administration A catheter thin plastic tube may be put into a vein in the arm and left in place to allow several blood samples to be drawn without repeated needle sticks
Urine tests several times during the study
HIV-infected persons who have been receiving HAART therapy for at least 12 months before enrolling in the study and have been stable on this treatment for at least 3 months before enrollment may be eligible for this study
Participants have about 10 clinic visits over 3 months They receive three injections of IL-7 one injection a week for 3 consecutive weeks The injections are given as a shot under the skin in the arm or leg On the day of each injection the participant stays in the clinic for up to 8 hours or longer for observation and collection of blood samples Three additional visits one every 3 months may be scheduled
During the study visits the following may be done
Medical history physical examination blood tests every visit
Electrocardiogram EKG at study days 0 day of first dose 1 7 day of second dose 14 day of third dose and 21
Chest x-ray study on day 21
Blood sample collections at frequent intervals during the first 96 hours after the first dose administration A catheter thin plastic tube may be put into a vein in the arm and left in place to allow several blood samples to be drawn without repeated needle sticks
Urine tests several times during the study
Detailed Description:
Interleukin 7 IL-7 is an essential cytokine for the thymic development and the post-thymic survival expansion and maturation of T lymphocytes in humans The rationale for using IL-7 as immunotherapy in HIV infection would be to support the expansion survival and functional properties of T lymphocytes and enhance immune reconstitution Phase I studies of a previous formulation of rhIL7 in cancer and HIV infected patients have shown that T cell proliferation and expansion can be achieved at doses that are well tolerated The newly glycosylated form of IL-7 tested in this study has a longer half-life allowing weekly administrations
This is a phase IIIa open label single arm trial that will test the safety of three subcutaneous injections of IL-7 at three different dose levels 10 20 and 30 microgramskilograms that will be tested sequentially Eligible subjects 400 cellsmicroliters greater than CD4 greater than 101 cellsmicroliters and VL less than 1000 copiesmilliliter on antiretroviral therapy for at least one year will be given 3 doses of IL-7 at weekly intervals day 0 day 7 and day 14 Participants will be followed on days 0 1 4 7 14 21 and 28 with additional visits on days 35 56 and 77 and optional follow up every 3 months thereafter until week 56 approximately 1 year after enrollment The three doses will be tested sequentially 10 20 and 30 microgramskilograms per dose and dose escalation will occur only when safety data from day 28 of the previous dose level participants are complete
Ten subjects will enroll in each dose level and dose escalation will occur only after all subjects complete four weeks without evidence of dose-limiting toxicities Secondary end points include a PK study of glycosylated rhIL7 as well as immunologic studies throughout the duration of the study to assess evidence of IL7 biologic activity with markers of T cell proliferation and expression of the alpha chain of the IL7 receptor This is a multi-center international study sponsored by Cytheris with sites in USA Canada Italy and France Children will be excluded and a separate study will be required in the future after the safety and biologic activity of this agent is established in adults The study will enroll a total of approximately 30 participants
This is a phase IIIa open label single arm trial that will test the safety of three subcutaneous injections of IL-7 at three different dose levels 10 20 and 30 microgramskilograms that will be tested sequentially Eligible subjects 400 cellsmicroliters greater than CD4 greater than 101 cellsmicroliters and VL less than 1000 copiesmilliliter on antiretroviral therapy for at least one year will be given 3 doses of IL-7 at weekly intervals day 0 day 7 and day 14 Participants will be followed on days 0 1 4 7 14 21 and 28 with additional visits on days 35 56 and 77 and optional follow up every 3 months thereafter until week 56 approximately 1 year after enrollment The three doses will be tested sequentially 10 20 and 30 microgramskilograms per dose and dose escalation will occur only when safety data from day 28 of the previous dose level participants are complete
Ten subjects will enroll in each dose level and dose escalation will occur only after all subjects complete four weeks without evidence of dose-limiting toxicities Secondary end points include a PK study of glycosylated rhIL7 as well as immunologic studies throughout the duration of the study to assess evidence of IL7 biologic activity with markers of T cell proliferation and expression of the alpha chain of the IL7 receptor This is a multi-center international study sponsored by Cytheris with sites in USA Canada Italy and France Children will be excluded and a separate study will be required in the future after the safety and biologic activity of this agent is established in adults The study will enroll a total of approximately 30 participants
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