Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001105
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Human Monoclonal Antibody F105 in the Treatment of HIV
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 Clinical Trial to Study the Toxicity Pharmacokinetics and Efficacy of Human Monoclonal Antibody F105 for Treating Human Immunodeficiency Virus 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 pharmacokinetics of F105 human monoclonal antibody both following a single dose and during intermittent administration in HIV-infected patients To determine specific dose concentrations sufficient to achieve efficacy and avoid toxicity To determine the effect of F105 on virologic immunologic and serologic parameters
Early in the course of HIV infection the primary humoral immune response appears to be highly strain specific and to be directed at a hypervariable portion of the viral gp120 The F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown to neutralize the IIIB SF2 and MN strains of HIV at concentrations readily achievable in humans
Early in the course of HIV infection the primary humoral immune response appears to be highly strain specific and to be directed at a hypervariable portion of the viral gp120 The F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown to neutralize the IIIB SF2 and MN strains of HIV at concentrations readily achievable in humans
Detailed Description:
Early in the course of HIV infection the primary humoral immune response appears to be highly strain specific and to be directed at a hypervariable portion of the viral gp120 The F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown to neutralize the IIIB SF2 and MN strains of HIV at concentrations readily achievable in humans
In Part A three cohorts of four patients each receive a single intravenous IV injection of F105 human monoclonal antibody at 1 of 3 doses The IV catheter will remain in the patients arm for 12 hours after injection for subsequent drawing of blood samples The third group highest dose will be studied only after the first two groups are analyzed for pharmacokinetics No more than two patients are enrolled per week Patients on Part A undergo follow-up three to four times within the first week after injection and weekly thereafter for 7 weeks Pharmacokinetic and toxicity data generated from Part A will be used to select two dose levels for intermittent administration in Part B In this part cohorts of four to six patients receive one of two doses of F105 for 8-12 weeks
Per 93094 amendment eight patients receive one dose of F105 every 21 days for four doses dose determined from analysis of Part A data
In Part A three cohorts of four patients each receive a single intravenous IV injection of F105 human monoclonal antibody at 1 of 3 doses The IV catheter will remain in the patients arm for 12 hours after injection for subsequent drawing of blood samples The third group highest dose will be studied only after the first two groups are analyzed for pharmacokinetics No more than two patients are enrolled per week Patients on Part A undergo follow-up three to four times within the first week after injection and weekly thereafter for 7 weeks Pharmacokinetic and toxicity data generated from Part A will be used to select two dose levels for intermittent administration in Part B In this part cohorts of four to six patients receive one of two doses of F105 for 8-12 weeks
Per 93094 amendment eight patients receive one dose of F105 every 21 days for four doses dose determined from analysis of Part A data
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 |
|---|---|---|---|
| 11209 | REGISTRY | DAIDS ES Registry Number | None |