Studies

A randomized, open-label, comparative study to evaluate the efficacy and tolerability of Indinavir/low dose Ritonavir BID versus Indinavir TID as part of combination antiretroviral therapy with CombivirR (AZT+3TC) for the treatment of HIV-1 infection in an antiretroviral pretreated Thai study population

December 31, 1998

Project no.: HIV-NAT 005

Introduction:

  • This study will be the first to evaluate a protease inhibitor as part of a triple drug regimen in the Thai HIV-infected population
  • Indinavir is a protease inhibitor of established efficacy and is licensed for use in Thailand. Ritonavir is also a protease inhibitor which, in addition to being an effective antiretroviral agent, impacts on indinavir metabolism. When given in low dose with indinavir, it may facilitate dosing with indinavir twice daily rather than three times daily
  • The combination may also remove the need for indinavir to be taken in a fasting state. It also results in higher trough and lower peak serum levels of indinavir that may, in turn, result in greater efficacy and reduced toxicity

Study Objectives:

  • Primary:
    • To assess the efficacy of the two drug regimens on HIV-1 viral load as measuresd by HIV-1 RNA quantification in plasma
  • Secondary:
    • To assess the efficacy of the two drug regimens on immune responses as measured by peripheral CD4+ lymphocyte counts
    • To assess safety and tolerability of the two regimens

Study Drugs: Patients will be randomized a 1:1 basis to: CombinavirR BID + Indinavir 800 mg BID + Ritonavir 100 mg BID versus CombinavirR BID + Indinavir 800 mg TID