Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)
Status:
Completed
Trial end date:
1996-01-01
Target enrollment:
Participant gender:
Summary
PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy.
To compare the anti-HIV activity of three blood concentration levels of this agent with
nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the
reduction of HIV viral burden.
SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug
exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To
assess anti-HIV activity using other disease markers.
Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent
and safe anti-HIV agents and may have different biological behavior than other currently
available non-nucleoside RT inhibitors.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)