Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105417
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2005-03-11
Brief Title:
Interluekin-7 to Treat HIV-Infected People Receiving Antiretroviral Treatment
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Randomized Placebo-Controlled Double-Blind Study Evaluating the Safety of Subcutaneous Single Dose Interleukin-7 in HIV-1-Infected Subjects Who Are Receiving Antiretroviral Treatment A5214
Status:
COMPLETED
Status Verified Date:
2006-05
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 whether interleukin-7 IL-7 a drug similar to the natural IL-7 protein produced by the body is safe to use in people infected with HIV IL-7 is important in immune system function In humans it can extend the life of immune cells called T-cells and increase their function and maturation in mice it can speed up immune system recovery following chemotherapy of transplantation and in monkeys it can make T-cells increase in numbers If this study shows that IL-7 is safe other trials will determine if it can improve the numbers or function of T-cells in HIV-infected people
Patients 18 years of age and older with HIV infection who have been taking anti-HIV medications for at least 12 months whose CD4 counts are at least 100 cellsmicroliter and whose viral load is no more than 50000 copiesmilliliter may be eligible for this study Candidates are screened with a physical examination blood and urine tests including a blood test for HLA type a genetic test of markers of the immune system chest x-ray electrocardiogram and ultrasound of the spleen
Participants undergo the following tests and procedures during 9 visits as follows
Pre-entry visit
Brief physical examination including examination of lymph nodes and spleen
Medical history including questions about current and past medications
Urine pregnancy test for women who are able to become pregnant
Blood draw for viral load immune responses and other routine safety tests
Entry visit
Complete physical examination including examination of lymph nodes and spleen
Routine urine test and urine pregnancy test for women who are able to become pregnant
Blood draw for viral load immune responses and other routine safety tests
IL-7 dosing Participants are randomly assigned to receive one of five doses of IL-7 3 10 30 60 or 100 micrograms per kilogram of body weight or placebo a salt solution that does not contain IL-7 The dose may be given in one or more injections with higher doses possibly requiring as many as seven or eight injections The injections are given subcutaneously under the skin usually in the arm or leg After the injection patients are monitored closely for 12 hours for skin or allergic reactions Blood is drawn before the injection and again at 05 1 15 2 25 4 8 and 12 hours after the injection to check blood levels of the study medication
Follow-up visits
Patients come to the clinic 7 times during follow-up-every day for the first 4 days after the injection then at 14 days 4 weeks and 8 weeks after the injection At most study visits patients have the following procedures
Brief physical examination including examination of lymph nodes and spleen
Routine urine test and urine pregnancy test for women who are able to become pregnant
Blood draw for viral load immune responses and other routine safety tests
Blood test to measure the amount of study medication in the blood 1 2 and 3 days after the injection
Electrocardiogram 1 day after the injection
Patients 18 years of age and older with HIV infection who have been taking anti-HIV medications for at least 12 months whose CD4 counts are at least 100 cellsmicroliter and whose viral load is no more than 50000 copiesmilliliter may be eligible for this study Candidates are screened with a physical examination blood and urine tests including a blood test for HLA type a genetic test of markers of the immune system chest x-ray electrocardiogram and ultrasound of the spleen
Participants undergo the following tests and procedures during 9 visits as follows
Pre-entry visit
Brief physical examination including examination of lymph nodes and spleen
Medical history including questions about current and past medications
Urine pregnancy test for women who are able to become pregnant
Blood draw for viral load immune responses and other routine safety tests
Entry visit
Complete physical examination including examination of lymph nodes and spleen
Routine urine test and urine pregnancy test for women who are able to become pregnant
Blood draw for viral load immune responses and other routine safety tests
IL-7 dosing Participants are randomly assigned to receive one of five doses of IL-7 3 10 30 60 or 100 micrograms per kilogram of body weight or placebo a salt solution that does not contain IL-7 The dose may be given in one or more injections with higher doses possibly requiring as many as seven or eight injections The injections are given subcutaneously under the skin usually in the arm or leg After the injection patients are monitored closely for 12 hours for skin or allergic reactions Blood is drawn before the injection and again at 05 1 15 2 25 4 8 and 12 hours after the injection to check blood levels of the study medication
Follow-up visits
Patients come to the clinic 7 times during follow-up-every day for the first 4 days after the injection then at 14 days 4 weeks and 8 weeks after the injection At most study visits patients have the following procedures
Brief physical examination including examination of lymph nodes and spleen
Routine urine test and urine pregnancy test for women who are able to become pregnant
Blood draw for viral load immune responses and other routine safety tests
Blood test to measure the amount of study medication in the blood 1 2 and 3 days after the injection
Electrocardiogram 1 day after the injection
Detailed Description:
Interleukin 7 is an essential cytokine for the thymic development and the post-thymic survival expansion and maturation of the T lymphocytes in humans Therapeutic use of IL7 in mouse models has shown enhancement of immune reconstitution after chemotherapy or bone marrow transplantation 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 More specifically IL7 may provide the means to support CD4 expansions in patients with good viral suppression but persistent low CD4 counts immunologic non-responders or in patients who have no available antiretroviral options Finally given the role of IL7 in T cell memory maturation and survival IL-7 may be a promising vaccine adjuvant
Studies of rhIL7 in non-human primates have shown that T cell proliferation and expansion can be achieved at doses that are well tolerated without significant toxicity A safety study in cancer patients is currently ongoing at the NCI A5214 Pleiades will be the first study of rhIL7 to evaluate the safety of a single subcutaneous injection in HIV infected adults Eligible subjects CD4 greater than 100 cellsmicro l and VL less than 50000 copiesml on antiretroviral therapy for at least one year will be stratified by viral load less than 50 or 50-50000 copiesml and will be randomized 31 to receive rhIL7 or placebo
Pleiades is a phase I double-blind trial that will test the safety of a single subcutaneous injection of IL-7 at 5 different doses 3 10 30 60 and 100 micro gkg tested sequentially Four 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 as reviewed by the safety monitoring committee Secondary end points include a PK study of rhIL7 as well as immunologic studies throughout the duration of the study to assess evidence of IL7 biologic activity with markers of T cell activation proliferation and differentiation as well as expression of the alpha chain of the IL7 receptor
This is an Adult AIDS Clinical Trial Group AACTG study and the NIAID will participate as a site The NIAID site will follow all NIAID IRB reporting requirements and all grade 1 and 2 toxicities will be included in the annual review 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 40-80 patients followed for a total of eight weeks with approximately 15-20 anticipated to enroll in our site
Studies of rhIL7 in non-human primates have shown that T cell proliferation and expansion can be achieved at doses that are well tolerated without significant toxicity A safety study in cancer patients is currently ongoing at the NCI A5214 Pleiades will be the first study of rhIL7 to evaluate the safety of a single subcutaneous injection in HIV infected adults Eligible subjects CD4 greater than 100 cellsmicro l and VL less than 50000 copiesml on antiretroviral therapy for at least one year will be stratified by viral load less than 50 or 50-50000 copiesml and will be randomized 31 to receive rhIL7 or placebo
Pleiades is a phase I double-blind trial that will test the safety of a single subcutaneous injection of IL-7 at 5 different doses 3 10 30 60 and 100 micro gkg tested sequentially Four 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 as reviewed by the safety monitoring committee Secondary end points include a PK study of rhIL7 as well as immunologic studies throughout the duration of the study to assess evidence of IL7 biologic activity with markers of T cell activation proliferation and differentiation as well as expression of the alpha chain of the IL7 receptor
This is an Adult AIDS Clinical Trial Group AACTG study and the NIAID will participate as a site The NIAID site will follow all NIAID IRB reporting requirements and all grade 1 and 2 toxicities will be included in the annual review 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 40-80 patients followed for a total of eight weeks with approximately 15-20 anticipated to enroll in our site
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 |
|---|---|---|---|
| 05-I-0112 | None | None | None |