A 96-week comparison of lopinavir-ritonavir combination therapy followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy

J Infect Dis. 2008 Jul 15;198(2):234-40. doi: 10.1086/589622.

Abstract

Antiretroviral-naive HIV-1-infected volunteers received zidovudine/lamivudine plus either lopinavir/ritonavir (n=104) or efavirenz (n=51). Lopinavir/ritonavir-treated subjects demonstrating 3 consecutive monthly HIV-1 RNA levels <50 copies/mL started lopinavir/ritonavir monotherapy. In previous-failure=failure analysis, 48% (lopinavir/ritonavir) and 61% (efavirenz) maintained HIV-1 RNA at <50 copies/mL through week 96, (P= .17; 95% confidence interval [CI] for the difference, -29% to 4%); in noncompletion=failure analysis, 60% (lopinavir/ritonavir) and 63% (efavirenz) maintained HIV-1 RNA at <50 copies/mL at week 96 (P= .73; 95% CI for the difference, -19% to 13%). Significant sparing of peripheral lipoatrophy was noted in the lopinavir/ritonavir simplification strategy. This study has provided important information for future studies using treatment simplified to lopinavir/ritonavir monotherapy.

Trial registration: ClinicalTrials.gov NCT00075231.

Publication types

  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acquired Immunodeficiency Syndrome / blood
  • Acquired Immunodeficiency Syndrome / drug therapy*
  • Alkynes
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use*
  • Benzoxazines / therapeutic use*
  • Cyclopropanes
  • Diarrhea / chemically induced
  • Drug Therapy, Combination
  • Glucose Tolerance Test
  • HIV Protease Inhibitors / adverse effects
  • HIV Protease Inhibitors / therapeutic use*
  • Humans
  • Lopinavir
  • Nausea / chemically induced
  • Pyrimidinones / therapeutic use*
  • RNA, Viral / blood
  • Ritonavir / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Viral Load

Substances

  • Alkynes
  • Anti-HIV Agents
  • Benzoxazines
  • Cyclopropanes
  • HIV Protease Inhibitors
  • Pyrimidinones
  • RNA, Viral
  • Lopinavir
  • efavirenz
  • Ritonavir

Associated data

  • ClinicalTrials.gov/NCT00075231