Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
Status:
Completed
Trial end date:
1998-05-01
Target enrollment:
Participant gender:
Summary
To elucidate the relationship between virologic risk factors and immunologic and clinical
progression in patients receiving monotherapy in protocol ACTG 175, and to compare new
treatment regimens with combinations of reverse transcriptase inhibitors in long-term
recipients of monotherapy. Specifically, to determine, in patients who have been taking
zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to
AZT or to switch to d4T alone, and also to determine, in patients who have been taking
didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to
ddI.
Characteristics of virus replication, pathogenicity, and resistance are thought to determine
the durability of virologic and clinical response to nucleoside reverse transcriptase
inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of
ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response
compared to continuation of AZT alone.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)