Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000977
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Active Immunization of Asymptomatic HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen A Phase III Study of Immunogenicity and Toxicity
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Active Immunization of Asymptomatic HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen A Phase III Study of Immunogenicity and Toxicity
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 determine the minimal effective immunogenic dose of vaccine in asymptomatic HIV-1 seropositive individuals with 400 cellsmm3 CD4 To determine the dose-response to a 4 fold escalation of the immunizing dose To describe both cellular and humoral immune responses to HIV-1 in the immunized individuals To describe the effects of this immunization on general immunological virological and clinical parameters To evaluate the safety of injecting recombinant gp160 in this population To evaluate the extent of variability between different lots of gp160 arms C1 and C2 It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine which could result in an immunological virological or clinical benefit
Detailed Description:
It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine which could result in an immunological virological or clinical benefit
ORIGINAL DESIGN Patients are randomized to one of five groups to receive intramuscularly one of four dosages of gp160 or hepatitis B vaccine as a control Treatments are given at 0 1 3 6 9 and 12 months and patients are followed for up to 2 years Patients in any of the 5 groups will have the option of switching to another dosage group if an interim analysis at 6 months shows significant differences in patient response AMENDED 102390 52 eligible patients are randomized to one of 6 study groups Five groups of 8 individuals receive one of 4 dosage levels of gp160 Groups A B C1 C2 and D and 12 patients receive a single dosage level of hepatitis B vaccine as a control Group E Per 21992 amendment patients may elect to continue receiving vaccine beyond 12 months with the doses given either every 3 months or every 6 months
ORIGINAL DESIGN Patients are randomized to one of five groups to receive intramuscularly one of four dosages of gp160 or hepatitis B vaccine as a control Treatments are given at 0 1 3 6 9 and 12 months and patients are followed for up to 2 years Patients in any of the 5 groups will have the option of switching to another dosage group if an interim analysis at 6 months shows significant differences in patient response AMENDED 102390 52 eligible patients are randomized to one of 6 study groups Five groups of 8 individuals receive one of 4 dosage levels of gp160 Groups A B C1 C2 and D and 12 patients receive a single dosage level of hepatitis B vaccine as a control Group E Per 21992 amendment patients may elect to continue receiving vaccine beyond 12 months with the doses given either every 3 months or every 6 months
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 |
|---|---|---|---|
| 11112 | REGISTRY | DAIDS ES Registry Number | None |