Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000762
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children 1 Month Old With Asymptomatic HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children 1 Month Old With Asymptomatic HIV Infection
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 safety and immunogenicity of gp160 MicroGeneSys rgp120HIV-1MN Genentech and rgp120HIV-1SF2 BIOCINE and their adjuvants in HIV-infected children 1 month to 18 years of age
The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts in the hope of forestalling the progression of HIV immunosuppression and clinical disease
The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts in the hope of forestalling the progression of HIV immunosuppression and clinical disease
Detailed Description:
The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts in the hope of forestalling the progression of HIV immunosuppression and clinical disease
Patients are randomized to receive one of three vaccines 9 patientsvaccine or the adjuvant placebos 3 patientsvaccine The vaccines will be studied at both low and high doses When three of four patients at the low dose of a vaccine have received two immunizations without evidence of dose-limiting toxicity dose escalation to the higher dose of that vaccine is initiated in subsequent patient cohorts provided all low dose arms are filled A total of six immunizations are given at 0 4 8 12 16 and 24 weeks Patients are followed for 24 weeks after the last immunization
Patients are randomized to receive one of three vaccines 9 patientsvaccine or the adjuvant placebos 3 patientsvaccine The vaccines will be studied at both low and high doses When three of four patients at the low dose of a vaccine have received two immunizations without evidence of dose-limiting toxicity dose escalation to the higher dose of that vaccine is initiated in subsequent patient cohorts provided all low dose arms are filled A total of six immunizations are given at 0 4 8 12 16 and 24 weeks Patients are followed for 24 weeks after the last immunization
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 |
|---|---|---|---|
| 11195 | REGISTRY | DAIDS ES Registry Number | None |