Intermittent administration of high-dose stavudine to nucleoside-experienced individuals infected with HIV-1

J Acquir Immune Defic Syndr. 2003 Jul 1;33(3):343-8. doi: 10.1097/00126334-200307010-00008.

Abstract

To explore a novel method to use nucleosides in heavily treated patients, 4-week cycles of high-dosage (280 mg/d) stavudine were given to 11 asymptomatic patients who had previously received an average of 6 years of nucleoside reverse transcriptase inhibitors (NRTIs). The stavudine dose was targeted to produce a calculated steady-state concentration of 1.5 microM (336 ng/mL). Participants received stavudine for the first 4 weeks, after which it was discontinued for 4 weeks. Additional 4-week drug cycles were given if plasma HIV-1 RNA levels increased to at least 75% of baseline values. The 11 subjects received 38 cycles (average, 3.5 cycles per subject) during the 44-week study. Stavudine was well tolerated. Considering all data, there was a median 0.65 log(10) reduction in viral load as well as a median increase in CD4 cell count of 110/mm3 at the end of the cycles. However, plasma viremia increased and CD4 cell counts decreased between cycles. Viral load and CD4 cell responses were similar for up to 4 successive cycles. This suggested that increasing viral resistance was not a problem, as reflected by the acquisition of only one new nucleoside reverse transcriptase mutation among the participants. Significant relationships between stavudine exposure and changes in plasma HIV RNA levels were observed. A similar approach might be considered using a more potent regimen for patients in whom resistance to nucleosides is a major reason for therapeutic failure.

Publication types

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

MeSH terms

  • Adult
  • Area Under Curve
  • CD4 Lymphocyte Count
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • HIV Reverse Transcriptase / genetics
  • HIV-1 / genetics
  • HIV-1 / isolation & purification
  • Humans
  • Male
  • Middle Aged
  • RNA, Viral / blood
  • Stavudine / administration & dosage*
  • Stavudine / adverse effects
  • Stavudine / pharmacokinetics
  • Stavudine / therapeutic use*

Substances

  • RNA, Viral
  • Stavudine
  • HIV Reverse Transcriptase