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Related Experiment Videos

Design and implementation of the stavudine parallel-track program

R E Anderson1, L M Dunkle, L Smaldone

  • 1Bristol-Myers Squibb Co., Pharmaceutical Research Institute, Wallingford, Connecticut 06492.

The Journal of Infectious Diseases
|March 1, 1995
PubMed
Summary
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This study evaluated stavudine

Area of Science:

  • Infectious Diseases
  • Clinical Pharmacology
  • HIV/AIDS Research

Background:

  • Advanced human immunodeficiency virus (HIV) infection presents significant treatment challenges.
  • Patients refractory to or intolerant of zidovudine and didanosine require alternative therapies.
  • Weight-based dosing strategies are crucial for optimizing drug efficacy and safety.

Purpose of the Study:

  • To assess the safety and efficacy of two weight-adjusted doses of stavudine.
  • To evaluate stavudine in patients with advanced HIV who failed prior therapies.
  • To determine the optimal dosing for different weight categories.

Main Methods:

  • Randomized, double-blind, large, simple trial design.
  • Weight-adjusted dosing of stavudine (20/40 mg, 15/30 mg, 10/20 mg based on weight).

Related Experiment Videos

  • Primary endpoints: survival, time to clinical progression, and time to dose-limiting neuropathy.

    • Main Results:

    • 8127 patients enrolled by July 31, 1993.
    • Stavudine reached a broad patient population via the parallel-track program.
    • Demographic analysis indicated overrepresentation of white men from coastal metropolitan areas.

    Conclusions:

    • Stavudine demonstrated potential benefit for advanced HIV patients.
    • The parallel-track program expanded access to stavudine.
    • Further analysis of demographic data is warranted to ensure equitable access.