Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000943
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Test If Giving Remune an HIV Vaccine Can Improve the Immune Systems of HIV-Positive Patients Who Are Also Participating 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:
A Controlled Pilot Study of the Immunogenicity of Remune in HIV-Infected Subjects Receiving Either Highly Active Antiretroviral Therapy HAART Alone or HAART and Interleukin-2 IL-2 A Nested Substudy of ACTG 328
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 determine the effects of an HIV vaccine Remune on the immune system This study involves patients who have received at least 60 weeks of anti-HIV therapy either alone or in combination with IL-2 while enrolled in ACTG 328
Remune is an experimental HIV vaccine To see how the bodys immune system reacts this vaccine will be given with 1 to 3 other vaccines and skin tests will monitor the bodys reaction
Remune is an experimental HIV vaccine To see how the bodys immune system reacts this vaccine will be given with 1 to 3 other vaccines and skin tests will monitor the bodys reaction
Detailed Description:
Proliferative responses to HIV antigens are either absent or of small magnitude in HIV-infected patients even in the early stages of infection when vigorous proliferative responses to recall antigens are still seen Remune consists of an inactivated gp120-depleted virus intended to stimulate HIV-specific immune responses Remune has been reported to increase lymphocyte proliferative responses to HIV antigens in patients with high CD4 cell counts Many other T-cell-dependent responses are also impaired in HIV-infected patients such as after vaccination with hepatitis A or B vaccine In this study patients with moderately advanced HIV disease who have already received 52 weeks of either HAART or HAART plus IL-2 are vaccinated with Remune and a control recall immunogen tetanus toxoid TT to evaluate whether these patients can develop new CD4 T-cell and CD8 T-cell responses to HIV-related antigens The antibody response to hepatitis A and hepatitis B vaccinations also will be explored
Fifty patients are enrolled in this substudy 17 from the HAART only arm Arm I of ACTG 328 and 33 from the HAART plus either CIV or subcutaneous IL-2 arms Arms II and III of ACTG 328 All patients are vaccinated 3 times with Remune and twice with TT If patients are hepatitis A total antibody negative they receive hepatitis A vaccine twice Additionally if patients are hepatitis B surface antigen negative hepatitis B core antibody and surface antibody negative they receive hepatitis B vaccine 3 times Patients who are negative for all hepatitis markers receive hepatitis A and B vaccines
Week 0 of A5046s begins at or after Week 64 of ACTG 328 for patients in the HAART-only arm or 4 weeks after the initiation of the seventh or any subsequent IL-2 cycle of ACTG 328 for patients in any of the IL-2-containing arms AS PER AMENDMENT 91699 Patients can be screened through Week 124 of ACTG 328 Patients receive Remune at Weeks 0 8 and 16 and TT at Weeks 0 and 8 Hepatitis A andor B vaccines are also given at these times if indicated Blood and skin tests are performed at Weeks 0 8 16 and 24 to measure immune response and lymphocyte proliferative responses
Fifty patients are enrolled in this substudy 17 from the HAART only arm Arm I of ACTG 328 and 33 from the HAART plus either CIV or subcutaneous IL-2 arms Arms II and III of ACTG 328 All patients are vaccinated 3 times with Remune and twice with TT If patients are hepatitis A total antibody negative they receive hepatitis A vaccine twice Additionally if patients are hepatitis B surface antigen negative hepatitis B core antibody and surface antibody negative they receive hepatitis B vaccine 3 times Patients who are negative for all hepatitis markers receive hepatitis A and B vaccines
Week 0 of A5046s begins at or after Week 64 of ACTG 328 for patients in the HAART-only arm or 4 weeks after the initiation of the seventh or any subsequent IL-2 cycle of ACTG 328 for patients in any of the IL-2-containing arms AS PER AMENDMENT 91699 Patients can be screened through Week 124 of ACTG 328 Patients receive Remune at Weeks 0 8 and 16 and TT at Weeks 0 and 8 Hepatitis A andor B vaccines are also given at these times if indicated Blood and skin tests are performed at Weeks 0 8 16 and 24 to measure immune response and lymphocyte proliferative responses
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5046s | Registry Identifier | DAIDS ES Registry Number | None |
| ACTG 328 Main Study | None | None | None |
| AACTG A5046s | None | None | None |
| 10794 | REGISTRY | None | None |