Studies

A randomized, open-label follow-up study of protocol HIV-NAT 001 to explore the antiretroviral efficacy and tolerability of switching to therapy with d4T/ddI/Saquinavir soft gel capsules versus Combivir (AZT/3TC)/Saquinavir soft gel capsules in an HIV-infected Thai population pretreated with AZT and ddC for at least 48 weeks

December 31, 1998

Project no.: HIV-NAT 001.1

Study Endpoint:

  • Primary:
    • Percentage of patients achieving sustained undetectable HIV-1 RNA in plasma (Amplicor HIV-1 Moniror) at 48 weeks
    • Degree and duration of increase in CD4+ cell counts from baseline
  • Secondary: Development of, or delay in development of, genotypic markers of reduced viral sensitivity to the study drugs

Study design:

  • All patients successfully completing 48 weeks of follow-up in study protocal 001 received open label AZT/ddC in standard doses for another 18 weeks in an ‘extension phase’ of study 001.
  • After a total of 66 weeks on study 001, they were switched to this study (001.1)
  • Participants monitored at baseline (week 66), weeks 70, 74, and every 8 weeks thereafter

Result: A formal, interim analysis is currently in progress (Jan 1999)