Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000675
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin rCd4-IgG Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex
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 Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin rCd4-IgG Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex
Status:
COMPLETED
Status Verified Date:
1991-01
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 study the safety and pharmacokinetics blood levels of recombinant human CD4 immunoglobulin rCd4-IgG in patients with AIDS or AIDS related complex ARC who have failed or declined therapy with zidovudine AZT An additional goal of the study is to obtain a preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC
Other approaches in addition to existing treatment of HIV infection need to be evaluated One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell In addition blocking the attachment of HIV to its cellular receptor may offer another point of attack HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus gp120 is capable of high affinity binding to CD4 Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread Recently scientists have succeeded in producing highly purified recombinant soluble human CD4 Recombinant CD4 is capable of binding to HIV envelope protein gp120 and inhibiting HIV infectivity in test tube studies Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects In order to extend the length of time that rCD4 stays in the body the compound has been modified by combining it with a human immunoglobulin of the IgG1 class IgG
Other approaches in addition to existing treatment of HIV infection need to be evaluated One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell In addition blocking the attachment of HIV to its cellular receptor may offer another point of attack HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus gp120 is capable of high affinity binding to CD4 Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread Recently scientists have succeeded in producing highly purified recombinant soluble human CD4 Recombinant CD4 is capable of binding to HIV envelope protein gp120 and inhibiting HIV infectivity in test tube studies Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects In order to extend the length of time that rCD4 stays in the body the compound has been modified by combining it with a human immunoglobulin of the IgG1 class IgG
Detailed Description:
Other approaches in addition to existing treatment of HIV infection need to be evaluated One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell In addition blocking the attachment of HIV to its cellular receptor may offer another point of attack HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus gp120 is capable of high affinity binding to CD4 Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread Recently scientists have succeeded in producing highly purified recombinant soluble human CD4 Recombinant CD4 is capable of binding to HIV envelope protein gp120 and inhibiting HIV infectivity in test tube studies Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects In order to extend the length of time that rCD4 stays in the body the compound has been modified by combining it with a human immunoglobulin of the IgG1 class IgG
Each patient receives rCd4-IgG at a fixed dose level once weekly by intravenous bolus for 12 weeks Four patients two per center are entered at each dose level starting with the lowest dose Dose escalation proceeds until a maximum tolerated dose MTD is defined AMENDED Includes as of 891201 an ancillary study entitled A Study of Recombinant CD4-Immunoglobulin G CD4-IgG Levels in Cerebral Spinal Fluid after rCD4-IgG is Administered by Intravenous Bolus in Patients With AIDS and AIDS-Related Complex This involves selected patients at the discretion of the Investigator AMENDED 900110 To increase the dose and frequency of administration of rCD4-IgG based on preliminary results of pharmacokinetic analyses from Phase I studies in humans Each patient receives rCD4-IgG therapy at a fixed dose level 1x 2x or 3x weekly by intravenous bolus for 12 weeks Follow-up is extended to 8 weeks Total target accrual is 25 - 28 weeks AMENDED 900824 Extension of the Phase I study of the safety and efficacy of CD4-IgG in patients with HIV infection Each patient receives one of two fixed doses by IV bolus injection twice per week for 12 weeks 20 to 30 patients to be enrolled Pharmacokinetics will be evaluated Clinical safety and antiviral effects will be assayed
Each patient receives rCd4-IgG at a fixed dose level once weekly by intravenous bolus for 12 weeks Four patients two per center are entered at each dose level starting with the lowest dose Dose escalation proceeds until a maximum tolerated dose MTD is defined AMENDED Includes as of 891201 an ancillary study entitled A Study of Recombinant CD4-Immunoglobulin G CD4-IgG Levels in Cerebral Spinal Fluid after rCD4-IgG is Administered by Intravenous Bolus in Patients With AIDS and AIDS-Related Complex This involves selected patients at the discretion of the Investigator AMENDED 900110 To increase the dose and frequency of administration of rCD4-IgG based on preliminary results of pharmacokinetic analyses from Phase I studies in humans Each patient receives rCD4-IgG therapy at a fixed dose level 1x 2x or 3x weekly by intravenous bolus for 12 weeks Follow-up is extended to 8 weeks Total target accrual is 25 - 28 weeks AMENDED 900824 Extension of the Phase I study of the safety and efficacy of CD4-IgG in patients with HIV infection Each patient receives one of two fixed doses by IV bolus injection twice per week for 12 weeks 20 to 30 patients to be enrolled Pharmacokinetics will be evaluated Clinical safety and antiviral effects will be assayed
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 |
|---|---|---|---|
| DO136g | None | None | None |