Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000721
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
An Escalating Dose Tolerance Trial of BG8962 rCD4 in Patients Who Are HIV Antibody Positive
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Escalating Dose Tolerance Trial of BG8962 rCD4 in Patients Who Are HIV Antibody Positive
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 maximal safe daily dose of BG8962 rCD4 which can be administered by continuous subcutaneous infusion CSCI over 24 hours to determine the pharmacokinetics of BG8962 when it is administered by intramuscular and subcutaneous routes and to look for dose related antiviral activity determined by quantitation of infectious HIV peripheral blood leukocytes PBLs and plasma and by monitoring the blood levels of viral p24 antigen when present CD4 T-cells and Beta-2- microglobulin Recombinant soluble CD4 protein rCD4 is a drug that has been produced by genetic engineering techniques In laboratory studies rCD4 binds to HIV and reduces its ability to enter the cell thus inhibiting its reproduction Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients it is necessary to determine the maximum dose that can be tolerated by humans AMENDED To date Biogens original sequence recombinant soluble CD4 and Biogens natural sequence recombinant soluble CD4 have both been referred to as recombinant soluble CD4 rsCD4 In order to distinguish between these two products a change in nomenclature has been made In this protocol whenever the original sequence CD4 molecule is referred to it is called recombinant soluble T4 rsT4 Whenever the natural sequence molecule currently under study in this protocol is referred to it is called BG8962 or rCD4 Whenever the drug is discussed generically it is referred to as rsCD4
Detailed Description:
Recombinant soluble CD4 protein rCD4 is a drug that has been produced by genetic engineering techniques In laboratory studies rCD4 binds to HIV and reduces its ability to enter the cell thus inhibiting its reproduction Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients it is necessary to determine the maximum dose that can be tolerated by humans AMENDED To date Biogens original sequence recombinant soluble CD4 and Biogens natural sequence recombinant soluble CD4 have both been referred to as recombinant soluble CD4 rsCD4 In order to distinguish between these two products a change in nomenclature has been made In this protocol whenever the original sequence CD4 molecule is referred to it is called recombinant soluble T4 rsT4 Whenever the natural sequence molecule currently under study in this protocol is referred to it is called BG8962 or rCD4 Whenever the drug is discussed generically it is referred to as rsCD4
The initial dose level is the highest dose previously established with other patients in this trial to be safe when administered intramuscularly IM Dose escalation is by semilogarithmic steps A shift from IM injection to continuous subcutaneous infusion CSCI is necessitated by the volume of drug which is administered as part of the escalation dose Three groups of eight patients each are treated as follows The first group of 8 patients receives BG8962 daily and consists of two cohorts of four patients each One cohort receives BG8962 as an IM injection The second cohort receives BG8962 as a continuous 24 hour infusion All patients in this group are treated for 12 weeks The second dosing group of 8 patients receive daily BG8962 by CSCI for 12 weeks The third group of 8 patients receive BG8962 by CSCI for 6 weeks Every two weeks during the study the following tests and evaluations are done Blood chemistry hematology urinalysis with microscopic exam and T-cells and T-cell subsets
The initial dose level is the highest dose previously established with other patients in this trial to be safe when administered intramuscularly IM Dose escalation is by semilogarithmic steps A shift from IM injection to continuous subcutaneous infusion CSCI is necessitated by the volume of drug which is administered as part of the escalation dose Three groups of eight patients each are treated as follows The first group of 8 patients receives BG8962 daily and consists of two cohorts of four patients each One cohort receives BG8962 as an IM injection The second cohort receives BG8962 as a continuous 24 hour infusion All patients in this group are treated for 12 weeks The second dosing group of 8 patients receive daily BG8962 by CSCI for 12 weeks The third group of 8 patients receive BG8962 by CSCI for 6 weeks Every two weeks during the study the following tests and evaluations are done Blood chemistry hematology urinalysis with microscopic exam and T-cells and T-cell subsets
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 |
|---|---|---|---|
| 066 Extension | Registry Identifier | DAIDS ES Registry Number | None |
| 11040 | REGISTRY | None | None |