A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons
Status:
Completed
Trial end date:
1995-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)