Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001475
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Trial of Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist in Patients With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2002-06
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:
Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen Prednisone is associated with avascular necrosis a condition that has been found in a number of patients in this study Also certain patients in this protocol may receive future interleukin-2 treatment cycles at home Home administration of IL-2 injections involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle
To be eligible for home administration of IL-2 patients must
Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1 year of treatment on the protocol with at least two well-tolerated outpatient cycles at a stable dose
Have a history of tolerable side effects while receiving IL-2 without frequent medical interventions intravenous fluid replacement or dose reductions
Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of the last two outpatient cycles
Have a strong relationship with a private physician or health-care provider who has been involved in the patients care and is willing to help supervise the patients care during each home IL-2 cycle
Live in a home with easy telephone access and have proved reliable in responding to telephone calls from clinic staff
Give the clinic staff contact information for a close friend or relative who will agree to serve as a caregiver during each home cycle providing the patient non-medical assistance and checking on his or her condition daily
Have reasonable access to emergency medical services and a nearby medical facility
Have proved reliable and consistent in using sterile technique reconstituting IL-2 vials and administering subcutaneous IL-2 injections
Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of their normal protocol participation
Have access to a home weight scale and be able to weigh themselves each day for safety monitoring
Participants will receive IL-2 cycles on the same schedule they followed in their original protocol participation They will be seen at the Clinical Center at regularly scheduled follow-up visits between cycles and for a medical evaluation and blood drawing before the start of each cycle to determine the safety of administering the cycle During the home cycle the patients case manager or other team member will place monitoring telephone calls on days 2 and 4 of the cycle and again a week later The timing and number of these calls may change depending on the findings of ongoing assessments of their usefulness Patients will be required to notify the study team promptly of any complications or other problems that develop with therapy
To be eligible for home administration of IL-2 patients must
Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1 year of treatment on the protocol with at least two well-tolerated outpatient cycles at a stable dose
Have a history of tolerable side effects while receiving IL-2 without frequent medical interventions intravenous fluid replacement or dose reductions
Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of the last two outpatient cycles
Have a strong relationship with a private physician or health-care provider who has been involved in the patients care and is willing to help supervise the patients care during each home IL-2 cycle
Live in a home with easy telephone access and have proved reliable in responding to telephone calls from clinic staff
Give the clinic staff contact information for a close friend or relative who will agree to serve as a caregiver during each home cycle providing the patient non-medical assistance and checking on his or her condition daily
Have reasonable access to emergency medical services and a nearby medical facility
Have proved reliable and consistent in using sterile technique reconstituting IL-2 vials and administering subcutaneous IL-2 injections
Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of their normal protocol participation
Have access to a home weight scale and be able to weigh themselves each day for safety monitoring
Participants will receive IL-2 cycles on the same schedule they followed in their original protocol participation They will be seen at the Clinical Center at regularly scheduled follow-up visits between cycles and for a medical evaluation and blood drawing before the start of each cycle to determine the safety of administering the cycle During the home cycle the patients case manager or other team member will place monitoring telephone calls on days 2 and 4 of the cycle and again a week later The timing and number of these calls may change depending on the findings of ongoing assessments of their usefulness Patients will be required to notify the study team promptly of any complications or other problems that develop with therapy
Detailed Description:
In the initial phase of this study HIV-infected patients with CD4 counts between 200 and 500 were randomized to receive either IL-2 alone by continuous IV infusion for 5 days every 8 weeks IL-2 plus anti-TNF antibody or IL-2 plus thalidomide The primary endpoints of this study are safety and tolerability of the IL-2TNF inhibitor combination Secondary endpoints will include changes in CD4 counts frequency and severity of IL-2 related side effects changes in serum TNF levels and plasma viral load changes The study period is one year with an optional extension period to follow Enrollment was for up to forty-five IL-2-naive patients
In the amended phase of this study up to 60 patients with HIV infection and CD4 counts equal to or greater than 350 will be studied to determine the ability of prednisone to ameliorate IL-2 related toxicity Patients will be randomized to one of four groups IL-2 alone IL-2 plus prednisone prednisone alone no treatment All four groups will be treated with a combination regimen of antiretrovirals to include at least one protease inhibitor IL-2 will be dosed SQ at a starting dosage of 75 mlU bid x 5 days every 8 weeks and prednisone or placebo will be dosed at 05 mgkgday during IL-2 cycles Primary endpoints are frequency of IL-2 associated fatigue and fever CD4 count changes and viral load changes Secondary endpoints include frequency of other IL-2 side effects concomitant medication use steroid associated side effects cytokine changes during IL-2 and IL-2 total exposure in the IL-2 plus steroid vs IL-2 plus placebo arms The study period is one year with an optional extension period to follow
In the amended phase of this study up to 60 patients with HIV infection and CD4 counts equal to or greater than 350 will be studied to determine the ability of prednisone to ameliorate IL-2 related toxicity Patients will be randomized to one of four groups IL-2 alone IL-2 plus prednisone prednisone alone no treatment All four groups will be treated with a combination regimen of antiretrovirals to include at least one protease inhibitor IL-2 will be dosed SQ at a starting dosage of 75 mlU bid x 5 days every 8 weeks and prednisone or placebo will be dosed at 05 mgkgday during IL-2 cycles Primary endpoints are frequency of IL-2 associated fatigue and fever CD4 count changes and viral load changes Secondary endpoints include frequency of other IL-2 side effects concomitant medication use steroid associated side effects cytokine changes during IL-2 and IL-2 total exposure in the IL-2 plus steroid vs IL-2 plus placebo arms The study period is one year with an optional extension period to follow
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 |
|---|---|---|---|
| 95-I-0133 | None | None | None |