Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006153
Status:
TERMINATED
Last Update Posted:
2008-07-30
First Post:
2000-08-07
Brief Title:
Effectiveness of Adding Remune to Your Current Anti-HIV Drug Combination
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Double-Blind Phase I Adjuvant Controlled Study to Evaluate the Effect of Remune HIV-1 Immunogen Compared to IFA in Combination With Fully Suppressive Antiviral Drug Therapy on HIV-1-Specific Immunogenicity in Subjects With Acute or Primary HIV-1 Infection
Status:
TERMINATED
Status Verified Date:
2003-06
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:
The purpose of this study is to see if giving a vaccine Remune is effective in HIV-positive patients who are also taking anti-HIV therapy
Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of the HIV virus in the body A vaccine called Remune works to stop the virus infection by boosting the bodys immune cell defense against the HIV virus before the virus enters cells It also blocks the virus from entering the cells This study will see whether Remune will improve the immune cell natural defense in patients who are also taking anti-HIV drugs
Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of the HIV virus in the body A vaccine called Remune works to stop the virus infection by boosting the bodys immune cell defense against the HIV virus before the virus enters cells It also blocks the virus from entering the cells This study will see whether Remune will improve the immune cell natural defense in patients who are also taking anti-HIV drugs
Detailed Description:
During primary HIV infection after an initial burst in viral load the body mounts an immunologic response to viral antigens It is thought that this initial immune response plays an important role in determining early and long-term suppression of HIV However limited information is available regarding the effect of early antiretroviral therapy on immune responses Therapeutic approaches such as Remune which augment cell-mediated immunologic responses may prove to be beneficial in controlling the progression of HIV infection especially when used in combination with antiretroviral therapy in early infection Current antiviral drugs work by inhibiting the infection of new cells yet seem to suppress early cell-mediated immune responses The question is raised as to whether immune-based therapies such as Remune may counteract the suppressive effects of antiretrovirals and slow the progression of infection
Patients receiving fully suppressive antiretroviral therapy are randomized to add either Remune or an Incomplete Freunds Adjuvant IFA control Vaccinations are administered on Day 1 Week 12 and Week 24 Blood samples are collected at Day 1 and Weeks 4 12 16 24 and 28 Clinical assessment includes lymphocyte proliferative response cytotoxic T lymphocyte CTL memory cell activity chemokine and cytokine measurements CD4 count and viral load Delayed-type hypersensitivity DTH skin tests are performed at Day 1 and Week 28 HIV-1 specific immunogenicity is coordinated with the response to antiretroviral therapy in patients
Patients receiving fully suppressive antiretroviral therapy are randomized to add either Remune or an Incomplete Freunds Adjuvant IFA control Vaccinations are administered on Day 1 Week 12 and Week 24 Blood samples are collected at Day 1 and Weeks 4 12 16 24 and 28 Clinical assessment includes lymphocyte proliferative response cytotoxic T lymphocyte CTL memory cell activity chemokine and cytokine measurements CD4 count and viral load Delayed-type hypersensitivity DTH skin tests are performed at Day 1 and Week 28 HIV-1 specific immunogenicity is coordinated with the response to antiretroviral therapy in patients
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 |
|---|---|---|---|
| 905 | None | None | None |