An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To establish the relationship between the oral dose of zidovudine (AZT) and its hematologic
toxicity. AZT has preliminarily been shown to decrease significant events and death in a
group of AIDS / Pneumocystis carinii pneumonia (PCP) and AIDS related complex (ARC) patients
followed at this time for a limited period. If these data withstand further follow-up, it
appears that AZT is a potential antiretroviral agent that may have application in the use of
all stages of HIV disease. At this time the optimal dose that will not cause significant
toxicity is not known. If this drug has widespread application, it becomes imperative to
further study both the dose and the toxicity. Patients with documented HIV viremia and who
are well will be evaluated in a dose-escalating protocol for toxicity, persistent viremia,
evidence of improvement of immune dysfunction, and the development of further manifestation
of HIV disease. Drug levels will be monitored and correlated with the toxicity and viremia.