Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000743
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase I Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons
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 Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons
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 tolerance of alvircept sudotox sCD4-PE40 given at various dosing intervals and concentrations To determine whether frequent dosing alters immunogenicity or toxicity To obtain preliminary data to ascertain whether sCD4-PE40 has activity against HIV in human subjects To determine whether there is any additive toxicity with combined use of sCD4-PE40 and zidovudine AZT
There is some evidence that AZT and sCD4-PE40 an experimental drug with anti-HIV activity previously demonstrated in vitro may produce increased benefit when used in combination in HIV-infected patients
There is some evidence that AZT and sCD4-PE40 an experimental drug with anti-HIV activity previously demonstrated in vitro may produce increased benefit when used in combination in HIV-infected patients
Detailed Description:
There is some evidence that AZT and sCD4-PE40 an experimental drug with anti-HIV activity previously demonstrated in vitro may produce increased benefit when used in combination in HIV-infected patients
Cohorts of six patients each receive escalating doses of sCD4-PE40 in a single IV weekly dose for 8 weeks All six patients at a given dose must complete 2 weeks of therapy without dose-limiting toxicity before dose escalation in subsequent patient cohorts may occur The MTD is defined as the dose of sCD4-PE40 immediately below that at which two or more of six patients experience grade 3 or higher toxicity or one or more of six patients experience grade 4 toxicity After the MTD for the once-weekly schedule is reached subsequent cohorts receive escalated doses of sCD4-PE40 on a 5x weekly schedule for approximately 4 weeks in an attempt to establish the MTD for that schedule When an MTD has been determined for the 5x weekly schedule and if antiretroviral activity is observed six additional patients receive this dose combined with AZT for 4 weeks
Cohorts of six patients each receive escalating doses of sCD4-PE40 in a single IV weekly dose for 8 weeks All six patients at a given dose must complete 2 weeks of therapy without dose-limiting toxicity before dose escalation in subsequent patient cohorts may occur The MTD is defined as the dose of sCD4-PE40 immediately below that at which two or more of six patients experience grade 3 or higher toxicity or one or more of six patients experience grade 4 toxicity After the MTD for the once-weekly schedule is reached subsequent cohorts receive escalated doses of sCD4-PE40 on a 5x weekly schedule for approximately 4 weeks in an attempt to establish the MTD for that schedule When an MTD has been determined for the 5x weekly schedule and if antiretroviral activity is observed six additional patients receive this dose combined with AZT for 4 weeks
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 |
|---|---|---|---|
| 11177 | REGISTRY | DAIDS ES Registry Number | None |