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

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.

Timeline

Start

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Primary completion

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Completion

1995-05

Publications

• Background Alston B, Mitsuyasu R, Lertora J, Flexner C, Timpone J, van der Horst C. Phase I study of sCd4-PE40 in HIV infected persons: (ACTG 201). Int Conf AIDS. 1993 Jun 6-11;9(1):498 (abstract no PO-B29-2178)
• Background Fiscus S, et al. Safety and efficacy of soluble CD4-pseudomonas exotoxin 40 in HIV infected individuals (ACTG 201). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:70

Drugs

Indications