Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000779
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With 500 CD4 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With 500 CD4 Cellsmm3
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:
PRIMARY To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cellsmm3
SECONDARY To determine whether significant advantages to any one vaccine exist
Before large clinical trials of anti-HIV vaccines are undertaken it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies
SECONDARY To determine whether significant advantages to any one vaccine exist
Before large clinical trials of anti-HIV vaccines are undertaken it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies
Detailed Description:
Before large clinical trials of anti-HIV vaccines are undertaken it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies
Patients are randomized to receive one of four vaccines or one of two placebo controls The vaccines are rgp 120HIV-1IIIB rgp 120HIV-1MN rgp 120HIV-1SF and env 2-3 The two control immunogens are aluminum hydroxide alum and BIOCINE Placebo Vaccine 2 MF-59 adjuvant emulsion in citrate buffer Patients are vaccinated at weeks 0 4 8 12 16 20 28 and 36 If significant benefit is seen among vaccine patients then placebo patients may receive vaccination with one of the immunogens producing an immune response
Patients are randomized to receive one of four vaccines or one of two placebo controls The vaccines are rgp 120HIV-1IIIB rgp 120HIV-1MN rgp 120HIV-1SF and env 2-3 The two control immunogens are aluminum hydroxide alum and BIOCINE Placebo Vaccine 2 MF-59 adjuvant emulsion in citrate buffer Patients are vaccinated at weeks 0 4 8 12 16 20 28 and 36 If significant benefit is seen among vaccine patients then placebo patients may receive vaccination with one of the immunogens producing an immune response
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 |
|---|---|---|---|
| 11191 | REGISTRY | DAIDS ES Registry Number | None |