Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000923
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
1999-11-02
Brief Title:
Treatment With Interleukin-2 IL-2 Plus Combination Anti-HIV-Drug Therapy HAART for Patients Formerly in ACTG 328
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Treatment Rollover for Subjects Formerly on ACTG 328 With Subcutaneous Interleukin-2 IL-2 in Combination With Highly Active Antiretroviral Therapy HAART
Status:
COMPLETED
Status Verified Date:
2012-05
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 examines the long-term effects of interleukin-2 IL-2 in combination with anti-HIV drugs or highly active antiretroviral therapy HAART The purpose of this study is to see if IL-2 can increase the number of CD4 cells cells of the immune system which fight infection in HIV-infected patients who have completed ACTG 328
HAART is often successful in decreasing viral load level of HIV in the blood but these drugs have not been able to restore the immune systems of HIV-infected patients IL-2 is a substance naturally produced by the bodys immune cells In ACTG 328 IL-2 is tested to see if it can increase the number of CD4 cells and boost a patients immune system This study is a follow-up to ACTG 328 so that patients who are benefiting from IL-2 can continue to take it and patients in the control group who do not receive IL-2 can start taking it
HAART is often successful in decreasing viral load level of HIV in the blood but these drugs have not been able to restore the immune systems of HIV-infected patients IL-2 is a substance naturally produced by the bodys immune cells In ACTG 328 IL-2 is tested to see if it can increase the number of CD4 cells and boost a patients immune system This study is a follow-up to ACTG 328 so that patients who are benefiting from IL-2 can continue to take it and patients in the control group who do not receive IL-2 can start taking it
Detailed Description:
HIV disease is characterized by a progressive decline in CD4 cells and an increase in viral burden Although antiretroviral therapy has been successful in controlling viral levels its effects on CD4 cell counts have been modest Intermittently administered IL-2 in the presence of HAART has been shown to increase CD4 cell counts decrease lymphocyte activation markers and increase certain lymphocyte functional activity in patients with early-stage HIV infection ACTG 328 evaluated the effects of intravenous andor subcutaneously administered IL-2 in conjunction with HAART in a group of more advanced HIV-infected patients over an 18- to 22-month period As patients were enrolled in this study over an 18-month period a follow-up protocol is required to provide continued IL-2 therapy for patients responding to IL-2 and patients in the control group who wish to receive this drug
This study enrolls patients who participated in ACTG 328 Patients in Arm I of ACTG 328 the control group receiving HAART only who have a viral load of 5000 copiesml or less register for Step II Patients in Step II receive subcutaneous SC IL-2 in combination with HAART IL-2 is administered for 5 days every 8 weeks for the first 3 cycles For subsequent cycles the interval between cycles may be extended in 8-week increments for a maximum of 24 weeks provided the patients bimonthly CD4 count exceeds 500 cellsmm3 Patients in Arm I who have a viral load greater than 5000 copiesml register for Step I which requires a change in antiretroviral therapy Patients who then achieve viral levels of 5000 copiesml or less may begin to receive IL-2 no earlier than 4 weeks and no later than 12 weeks after the change in HAART regimen Patients whose viral load remains above 5000 copiesml for 12 weeks after the change in drug regimen are discontinued from the study Patients in Arms II or III of ACTG 328 IL-2-containing arms who have had a 25 percent or greater increase in CD4 cell count above their Week 11 value and have a viral load of 5000 copiesml or less continue on SC IL-2 and HAART Patients who meet the CD4 criteria but whose viral load is above 5000 copiesml change their HAART regimen After a minimum of 4 weeks and a maximum of 12 weeks these patients may receive IL-2 provided they have a viral load of 5000 copiesml or less For this study HAART is defined as one protease inhibitor and two nucleoside analogues AS PER AMENDMENT 91699 All patients must receive a protease inhibitor or with permission of the chair a nonnucleoside reverse transcriptase inhibitor NNRTI plus either two nucleoside reverse transcriptase inhibitors NRTIs or another protease inhibitor or NNRTI The protease inhibitor provided on this study is indinavir IDV The nucleoside analogue combinations provided on this study are as follows zidovudine ZDV plus didanosine ddI ZDV plus lamivudine 3TC stavudine d4T plus 3TC or d4T plus ddI Other antiretroviral drugs may be used but are not provided by this study Patients are monitored for CD4 counts at bimonthly intervals after the first IL-2 dose CD4 counts and plasma storage for HIV RNA are done within 96 hours prior to each cycle of IL-2 Safety laboratory evaluations are obtained prior to and at the conclusion of each IL-2 course TSH thyroid-stimulating hormone DTH skin testing and real-time plasma HIV RNA are obtained at 6-month intervals
This study enrolls patients who participated in ACTG 328 Patients in Arm I of ACTG 328 the control group receiving HAART only who have a viral load of 5000 copiesml or less register for Step II Patients in Step II receive subcutaneous SC IL-2 in combination with HAART IL-2 is administered for 5 days every 8 weeks for the first 3 cycles For subsequent cycles the interval between cycles may be extended in 8-week increments for a maximum of 24 weeks provided the patients bimonthly CD4 count exceeds 500 cellsmm3 Patients in Arm I who have a viral load greater than 5000 copiesml register for Step I which requires a change in antiretroviral therapy Patients who then achieve viral levels of 5000 copiesml or less may begin to receive IL-2 no earlier than 4 weeks and no later than 12 weeks after the change in HAART regimen Patients whose viral load remains above 5000 copiesml for 12 weeks after the change in drug regimen are discontinued from the study Patients in Arms II or III of ACTG 328 IL-2-containing arms who have had a 25 percent or greater increase in CD4 cell count above their Week 11 value and have a viral load of 5000 copiesml or less continue on SC IL-2 and HAART Patients who meet the CD4 criteria but whose viral load is above 5000 copiesml change their HAART regimen After a minimum of 4 weeks and a maximum of 12 weeks these patients may receive IL-2 provided they have a viral load of 5000 copiesml or less For this study HAART is defined as one protease inhibitor and two nucleoside analogues AS PER AMENDMENT 91699 All patients must receive a protease inhibitor or with permission of the chair a nonnucleoside reverse transcriptase inhibitor NNRTI plus either two nucleoside reverse transcriptase inhibitors NRTIs or another protease inhibitor or NNRTI The protease inhibitor provided on this study is indinavir IDV The nucleoside analogue combinations provided on this study are as follows zidovudine ZDV plus didanosine ddI ZDV plus lamivudine 3TC stavudine d4T plus 3TC or d4T plus ddI Other antiretroviral drugs may be used but are not provided by this study Patients are monitored for CD4 counts at bimonthly intervals after the first IL-2 dose CD4 counts and plasma storage for HIV RNA are done within 96 hours prior to each cycle of IL-2 Safety laboratory evaluations are obtained prior to and at the conclusion of each IL-2 course TSH thyroid-stimulating hormone DTH skin testing and real-time plasma HIV RNA are obtained at 6-month intervals
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 |
|---|---|---|---|
| ACTG A5051 | Registry Identifier | DAIDS ES Registry Number | None |
| 10205 | REGISTRY | None | None |
| Substudy ACTG A5052s | None | None | None |
| Substudy ACTG A5053s | None | None | None |
| Substudy ACTG A5054s | None | None | None |
| Substudy ACTG A5094s | None | None | None |
| AACTG A5051 | None | None | None |