A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC
Status:
Completed
Trial end date:
1995-02-01
Target enrollment:
Participant gender:
Summary
To determine the safety, toxicity, pharmacokinetic profile, and antiretroviral activity of
atevirdine mesylate ( U-87201E ) in HIV-infected patients. Per 06/04/93 amendment, to also
evaluate the interactive effects of didanosine ( ddI ) or zalcitabine ( dideoxycytidine; ddC
) with zidovudine ( AZT ) on the pharmacokinetics of U-87201E and to assess the effects of
the triple combination therapies on immunologic and virologic parameters.
Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been
associated with the rapid development of resistant HIV isolates, an initial evaluation of
this drug in patients was made in combination with AZT. Because of the inability to detect
resistance after 6 weeks of combined AZT/U-87201E therapy, this protocol will initially
investigate U-87201E administered alone and then investigate the effect of this drug with AZT
and ddI or ddC.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)