Search / Trial NCT00002349

A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Aids Related Complex Stavudine

ClinConnect Summary

Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Recent HIV infection.
  • No prior antiretroviral therapy.
  • No acute opportunistic infection at study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Intractable diarrhea.
  • Bilateral peripheral neuropathy.
  • Any other condition that would preclude study therapy.
  • Concurrent Medication:
  • Excluded:
  • Myelosuppressive, neurotoxic, or hepatotoxic drugs.
  • Patients with the following prior condition are excluded:
  • History of bilateral peripheral neuropathy.
  • Prior Medication:
  • Excluded:
  • Prior antiretroviral therapy.
  • Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.

Trial Officials

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Principal Investigator

About Bristol Myers Squibb

Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.

Locations

San Diego, California, United States

Portsmouth, Virginia, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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