Studies

A randomized, open-label study to explore the antiretroviral efficacy and tolerability of immediate versus deferred switching from ddI/d4T to AZT/3TC in a Thai HIV-1 infected population, pretreated with ddI/d4T

December 31, 1998

Project no.: HIV-NAT 002.1

Background: This roll-over protocal followed study HIV-NAT 002. 71 patients were re-randomized to immediate switch to AZT/3TC (at week 48) versus deferred switch when considered as failing ddI/d4T treatment on study 002. Mirror image study is re-randomizing participants taking AZT/3TC on HIV-NAT 003 to immediate versus deferred switch to ddI/d4T.

Method:

  • Re-randomization was based on defining ddI/d4T failure as rebound of viral load (Chiron bDNA) of 1log10 or more above nadir reached at week 36 or any time point thereafter.
  • According to this definition, 68 participants were still considered as responders
    • 31 randomized to immediate switch to AZT/3TC
    • 37 randomized to deferred switch and remained on ddI/d4T
    • 3 participants non-responders at week 48 and not eligible for re-randomized received AZT/3TC at week 48.

Follow up:

  • Clinical and laboratory evaluation every 8 weeks
  • Additional visit at 4 weeks after switch

Results:

  • All participants reached week 88
  • Interim analysis performed
  • Both treatment arms were safe and well tolerated
  • One participant lost to follow up at week 72
  • 67 re-randomized participants remain on study
  • Final report will be presented as a poster at the 6th Conference on Retroviruses and Opportunistic Infections in Chicago Feb 1999
  • At week 88, 10 participnats in the deferred arm had been switched to AZT/3TC