Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002353
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
Sponsor:
United Biomedical
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
Status:
COMPLETED
Status Verified Date:
1997-07
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 an HIV lipopeptide immunotherapeutic P3C541b at two dose levels administered subcutaneously in HIV-seropositive patients
Detailed Description:
Patients are randomized to receive P3C541b or placebo within each of two study groups Enrollment in the first group will be independent of HLA type whereas all but two of the patients enrolled in group 2 must have one or more HLA types A33 B8 B27 or Bw62 Treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity
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 |
|---|---|---|---|
| V103B | None | None | None |