A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine, lamivudine, and efavirenz for the treatment of chronic HIV infection

J Infect Dis. 2004 Jun 1;189(11):1974-82. doi: 10.1086/386344. Epub 2004 May 10.

Abstract

Background: We previously demonstrated that short-cycle structured intermittent therapy (SIT; 7 days without therapy followed by 7 days with antiretroviral therapy [ART]) with a ritonavir-boosted, indinavir-based, twice-daily regimen maintained suppression of plasma HIV viremia while reducing serum levels of lipids. Adherence to such a regimen may be problematic for certain patients.

Methods: Eight patients with a history of receiving combination ART that maintained suppression of plasma HIV RNA to <50 copies/mL received a once-daily SIT regimen of didanosine, lamivudine, and efavirenz.

Results: For 7 patients, suppression of plasma HIV RNA to <50 copies/mL was maintained for 60-84 weeks. Four patients with adequate samples had no evidence for an increase in plasma viremia for up to 72 weeks, by use of an assay with a limit of detection of <1 copy/mL. The lack of rebound viremia may be the result of the persistence of efavirenz in plasma on day 7 of the no-therapy period, as was detected in 7 of 7 patients. There was no significant change in CD4(+) T cell counts or serum hepatic transaminase or lipid levels.

Conclusion: A once-daily short-cycle SIT regimen maintained suppression of plasma HIV RNA while preserving CD4(+) T cell counts. Such a regimen may have importance in resource-limited settings where the monetary cost of continuous ART is prohibitive.

Publication types

  • Clinical Trial

MeSH terms

  • Alanine Transaminase / blood
  • Alkynes
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / blood
  • Aspartate Aminotransferases / blood
  • Benzoxazines
  • Cholesterol / blood
  • Cyclopropanes
  • DNA, Viral / chemistry
  • DNA, Viral / genetics
  • Didanosine / administration & dosage*
  • Didanosine / blood
  • Drug Resistance, Viral
  • Drug Therapy, Combination
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • HIV-1 / genetics*
  • Humans
  • Lamivudine / administration & dosage*
  • Lamivudine / blood
  • Oxazines / administration & dosage*
  • Oxazines / blood
  • Polymerase Chain Reaction
  • RNA, Viral / blood
  • Triglycerides / blood

Substances

  • Alkynes
  • Anti-HIV Agents
  • Benzoxazines
  • Cyclopropanes
  • DNA, Viral
  • Oxazines
  • RNA, Viral
  • Triglycerides
  • Lamivudine
  • Cholesterol
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • efavirenz
  • Didanosine