A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)
Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in
HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to
determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT.
Parts 1B and 2: To test for additive or synergistic activity between rsCD4 and AZT as judged
by falls in HIV-1 p24 antigen levels; and to evaluate the safety of rsCD4 and AZT in patients
with AIDS and advanced ARC.
AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without
toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow
function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT
have now been found which appear to have reduced sensitivity to AZT. The incidence of
toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability
to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4
(rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and
ARC patients either as a single agent or in combination with AZT.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)