A Phase I, Dose-Escalating Safety & Tolerance Study of sCD4-PE40 in

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT00000743
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Completion date	May 1995

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A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms