Search / Trial NCT00002372

A Study of 141W94 in Combination With Other Anti-HIV Drugs

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Drug Therapy, Combination Administration, Oral Hiv Protease Inhibitors Indinavir Saquinavir Nelfinavir Vx 478

ClinConnect Summary

Patients will be randomized to receive open label 141W94 in combination with saquinavir, indinavir and nelfinavir. The randomized phase will be preceded by a single dose pharmacokinetic interaction study of 141W94 and indinavir in 12 patients. Data from this single dose investigation will be used to determine the dose of indinavir to be used in the randomized phase.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed provided used with caution:
  • Medications that may interact at CYP3A4 (either a substrate, inhibitor or inducer of the enzyme) should be used with caution.
  • Patients must have:
  • Documented HIV infection.
  • CD4+ cell count \>= 200 cells/mm3.
  • 1. Anticipated need for treatment with cytotoxic chemotherapeutic agents within the study time period.
  • Treatment with immunomodulating agents.
  • * Medications that should not be administered with 141W94:
  • Terfenadine. Astemizole. Cisapride. Triazolam. Midazolam. Ergotamine/Dihydroergotamine-containing regimens. Antiretroviral drugs. Vitamin E supplements. Other experimental agents.
  • Anticipated need for radiation therapy within the study time period.
  • 1. Prior protease inhibitors.
  • Antiretroviral therapy within 2 weeks prior to entry.
  • Treatment with cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
  • Radiation therapy within 4 weeks prior to entry. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing and protocol evaluations.

About Glaxo Wellcome

Glaxo Wellcome, a leading global biopharmaceutical company, is dedicated to advancing healthcare through innovative research and development of new therapies. With a strong focus on addressing unmet medical needs, Glaxo Wellcome combines scientific excellence with a commitment to improving patient outcomes across various therapeutic areas, including respiratory, infectious diseases, and oncology. The company is recognized for its robust clinical trial portfolio, leveraging cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. Glaxo Wellcome upholds the highest ethical standards in clinical research, ensuring patient safety and integrity throughout the trial process.

Locations

Durham, North Carolina, United States

San Francisco, California, United States

San Diego, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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