Viewing Study NCT00000822



Ignite Creation Date: 2024-05-05 @ 11:08 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00000822
Status: COMPLETED
Last Update Posted: 2021-10-29
First Post: 1999-11-02

Brief Title: A Phase III Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500mm3 CD4 T Cells and 200-400mm3 CD4 T Cells
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: A Phase III Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500mm3 CD4 T Cells and 200-400mm3 CD4 T Cells
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: To evaluate the safety and immunogenicity of HIV-1 MN rgp160 Immuno-AG in HIV-infected patients To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation specific antibody responses and DTH reaction To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months AS PER AMENDMENT 111296 stratum 1 patients only To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections AS PER AMENDMENT 111296 stratum 1 patients only

HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression
Detailed Description: HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression

Patients with CD4 counts greater than or equal to 500 cellsmm3 are randomized to receive HIV-1 MN rgp160 Immuno-AG or control Patients with CD4 counts 50-499 cellsmm3 receive didanosine ddI and are then randomized to receive ddI plus vaccine or control Vaccine or control is given every 4 weeks for 7 injections then every 8 weeks for 6-12 months or until 1 year after the last patient is randomized AS PER AMENDMENT 111296 Stratum 1 is composed of 16 subjects with CD4 T cells greater than or equal to 500 mm3 These subjects are randomized to vaccine therapy or vaccine control HIV-1 MN rgp160 vaccine or control is given every 4 weeks for 7 injections Schedule 1 then every 8 weeks until 52 weeks after the last subject has been randomized to stratum 1 Schedule 2 Stratum 1 patients receive ddI or d4T only if their CD4 cell count has a sustained decrease on 2 consecutive occasions 10-14 days apart andor HIVRNA plasma viral load increases to greater than 10000 copiesml on 2 consecutive occasions 10-14 days apart Stratum 2 is composed of 30 subjects with CD4 T cells 200-400mm3 accrual to this stratum was activated based on preliminary results from stratum 1 closed as of 4597 Patients on stratum 2 open as of 3497 initially receive ritonavir at escalating doses for 2 weeks Subjects then have ddI and d4T added to the regimen for 7 weeks Subjects are then randomized to vaccine therapy or vaccine control every 4 weeks for 7 injections with ritonavirddId4T continued during vaccine therapy

AS PER AMENDMENT 32398 As of 6198 vaccine consists of sodium chloride for injection USP

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
11223 REGISTRY None None
11499 REGISTRY DAIDS ES Registry Number None