Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000909
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cellsmm3 Who Do Not Wish to Receive Anti-HIV Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open Label Phase II Study of Subcutaneous Interleukin-2 Proleukin Alone vs No Therapy in Patients With HIV Infection and at Least 350 CD4 Cellsmm3 Who Do Not Wish to Receive Treatment With Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2 IL-2 alone to HIV-positive patients with CD4 cell counts greater than 350 cellsmm3 who do not wish to receive anti-HIV antiretroviral therapy This study will also determine if IL-2 given alone can increase CD4 cell counts or decrease the level of HIV in the blood
IL-2 a protein found in the blood that helps boost the immune system can result in increases in CD4 cell count immune system cells that fight infection IL-2 is normally given in combination with antiretroviral therapy to treat HIV infection however some HIV patients do not wish to take antiretrovirals This study asks if it is safe and effective to take IL-2 alone to treat HIV infection
IL-2 a protein found in the blood that helps boost the immune system can result in increases in CD4 cell count immune system cells that fight infection IL-2 is normally given in combination with antiretroviral therapy to treat HIV infection however some HIV patients do not wish to take antiretrovirals This study asks if it is safe and effective to take IL-2 alone to treat HIV infection
Detailed Description:
Previous studies have shown that interleukin-2 when given under the skin results in CD4 cell count increases and may impact upon disease progression A Phase III trial is the next step in the development of these efficacy trials One question however has not been addressed in previous IL-2 studies whether it is both safe and reasonable to allow prospective IL-2 recipients the autonomy of choosing whether or not to take antiretrovirals in addition to their cytokine therapy This trial addresses that concern
In this open-label study 36 patients are randomized to 1 of 3 treatment groups of 12 patients each
Group I IL-2 every 12 hours for 5 days every 8 weeks Group II IL-2 every 12 hours for 5 days every 8 weeks higher IL-2 dose Group III Control group receiving no therapy Patients must complete a minimum of 3 8-week cycles of treatment Twelve patients are randomized to each arm Following study completion Group I and II patients may elect to continue receiving IL-2 during follow-up or as part of an additional protocol based on the results of this study
AS PER AMENDMENT 21299 Patients who have received study medication andor routine protocol visits and procedures for at least 6 months with acceptable compliance are eligible for continued follow-up in an extension phase The extension phase will continue for at least 1 year from the date when the last patient has been enrolled in the extension phase Patients originally randomized to IL-2 may continue to receive IL-2 during the extension period with IL-2 therapy guided on an individual basis Patients originally randomized to no therapy may continue to receive no therapy during the extension phase AS PER AMENDMENT 71100 Patients demonstrating acceptable compliance with routine visits and procedures during the initial treatment phase andor extension phase may participate in the long-term follow-up phase which requires follow-up visits at least every 4 months for approximately 5 years Patients originally randomized to Group 1 or 2 may continue to receive IL-2 with IL-2 therapy guided on an individual basis during the long-term follow-up phase Patients originally randomized to Group 3 may continue to receive no therapy during the long-term follow-up phase
In this open-label study 36 patients are randomized to 1 of 3 treatment groups of 12 patients each
Group I IL-2 every 12 hours for 5 days every 8 weeks Group II IL-2 every 12 hours for 5 days every 8 weeks higher IL-2 dose Group III Control group receiving no therapy Patients must complete a minimum of 3 8-week cycles of treatment Twelve patients are randomized to each arm Following study completion Group I and II patients may elect to continue receiving IL-2 during follow-up or as part of an additional protocol based on the results of this study
AS PER AMENDMENT 21299 Patients who have received study medication andor routine protocol visits and procedures for at least 6 months with acceptable compliance are eligible for continued follow-up in an extension phase The extension phase will continue for at least 1 year from the date when the last patient has been enrolled in the extension phase Patients originally randomized to IL-2 may continue to receive IL-2 during the extension period with IL-2 therapy guided on an individual basis Patients originally randomized to no therapy may continue to receive no therapy during the extension phase AS PER AMENDMENT 71100 Patients demonstrating acceptable compliance with routine visits and procedures during the initial treatment phase andor extension phase may participate in the long-term follow-up phase which requires follow-up visits at least every 4 months for approximately 5 years Patients originally randomized to Group 1 or 2 may continue to receive IL-2 with IL-2 therapy guided on an individual basis during the long-term follow-up phase Patients originally randomized to Group 3 may continue to receive no therapy during the long-term follow-up phase
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 |
|---|---|---|---|
| 10462 | REGISTRY | None | None |
| IL-2 UK | Registry Identifier | DAIDS ES | None |