Studies

A randomized, open-label, follow-up study to protocol HIV-NAT 003 to explore the antiviral efficacy and tolerability of immediate switching to therapy with d4T/ddI versus continued AZT/3TC and deferred switching to d4T/ddI in a population pretreated with AZT/3TC for at least 48 weeks and comparing these strategies with immediate switching to therapy with d4T/3TC/Abacavir versus continued AZT/3TC/ddI and deferred switching to d4T/3TC/Aacavir in a population pretreated with AZT/3TC/ddI for at least 48 weeks

December 31, 1998

Project no.: HIV-NAT 003.1

Study Objectives:

  • To explore the antiretroviral efficacy and tolerability of therapy with d4T/ddI in patients pretreated with AZT/3TC and therapy with d4T/3TC/Abacavir in patients pretreated with AZT/3TC/ddI for at least 48 weeks
  • To access whether the switching of combination antiretroviral therapy before treatment failure is apparent (immediate switching) results in better virological and/or immunological responses then switching once treatment failure has become apparent (delayed switching)
  • To explore the degree and duration of antiretroviral activity of double amd triple nucleoside combinations of AZT/3TC and AZT/3TC/ddI

Study Design:

  • 101 patients entered this study
  • 7 patients were failing therapy at the commencement of study and were switched immediately from AZT/3TC to d4T/ddI or from AZT/3TC/ddI to d4T/3TC/Abacavir
  • The remaining 97 patients were re-randomized as follow:
    • Immediate or deferred switching from AZT/3TC to d4T/ddI
    • Immediate or deferred switching from AZT/3TC/ddI to d4T/3TC/Abacavir

Result: Pending