Efficacy and tolerability of stavudine plus lamivudine in treatment-naive and treatment-experienced patients with HIV-1 infection

Ann Intern Med. 1998 Oct 1;129(7):525-31. doi: 10.7326/0003-4819-129-7-199810010-00003.


Background: A combination of two nucleoside analogues is currently the core of any antiretroviral regimen for HIV-1 infection. Stavudine plus lamivudine has shown an additive effect in vitro, as well as an absence of overlapping toxicity and cross-resistance.

Objective: To evaluate the antiviral efficacy of stavudine plus lamivudine in treatment-naive patients and in patients previously treated with other nucleoside reverse transcriptase inhibitors.

Design: Prospective, open-label pilot study.

Setting: Three urban clinical centers in Paris.

Patients: 83 patients with CD4+ cell counts between 50 and 400 cells/mm3 (42 treatment-naive and 41 treatment-experienced patients).

Interventions: Stavudine, 40 mg twice daily (30 mg twice daily in patients with a body weight < or = 60 kg), and lamivudine, 150 mg twice daily.

Measurements: Primary end points for efficacy included changes in plasma viral load and CD4+ cell count at 24 weeks compared with baseline.

Results: Therapy with stavudine plus lamivudine resulted in a median decrease of 1.66 log10 (10(1.66)) (range, -3.04 to -0.79 log10) in plasma HIV-1 RNA; the median increase in CD4+ cell count was 108 cells/mm3 (range, -58 to 406 cells/mm3) at week 24 in treatment-naive patients. In treatment-experienced patients, the median reduction in plasma HIV-1 RNA was 0.55 log10 (range, -2.86 to 0.52 log10), and the median increase in CD4+ cell count was 46 cells/mm3 (range, -188 to 311 cells/mm3). The percentages of patients with less than 3000 HIV-1 RNA copies/mL and less than 400 copies/mL at 24 weeks were, respectively, 57% (95% CI, 41% to 72%) and 26% (CI, 12% to 40%) among treatment-naive patients and 22% (CI, 10% to 38%) and 5% (CI, 1% to 17%) among treatment-experienced patients. Of 82 patients, 14 (17%) experienced grade 3 or 4 toxicity and 2 discontinued therapy because of intolerance toward treatment.

Conclusion: Stavudine plus lamivudine seems to have a potent antiviral effect in treatment-naive and treatment-experienced patients. No major drug-limiting toxicity was found. This two-nucleoside combination should be considered in multidrug therapy for HIV.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / adverse effects*
  • Anti-HIV Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • HIV Seropositivity / drug therapy*
  • HIV Seropositivity / immunology
  • HIV Seropositivity / virology
  • HIV-1*
  • Humans
  • Lamivudine / adverse effects*
  • Lamivudine / therapeutic use*
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • RNA, Viral / blood
  • Stavudine / adverse effects*
  • Stavudine / therapeutic use*
  • Viral Load


  • Anti-HIV Agents
  • RNA, Viral
  • Lamivudine
  • Stavudine