Search / Trial NCT00002195

A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Drug Therapy, Combination Zidovudine Hiv Protease Inhibitors Lamivudine Vx 478 Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

ClinConnect Summary

This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • HIV-positive status.
  • Screening viral load \>= 10,000 copies/mm3 14 days prior to entry.
  • CD4+ cell counts \>= 200 cells/mm3 14 days prior to entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Clinical diagnosis of AIDS (CDC 1993 Classification C).
  • Concurrent Medication:
  • Excluded:
  • Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.
  • Patients with the following prior conditions are excluded:
  • Clinically relevant hepatitis in the previous 6 months.
  • Prior Medication:
  • Excluded:
  • Greater than 4 weeks of any nucleoside antiretroviral therapy.
  • Previous therapy with an HIV protease inhibitor.
  • Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
  • Immunomodulating agents within 3 months prior to entry.
  • Prior Treatment:
  • Excluded:
  • Radiotherapy within 4 weeks prior to entry.
  • Risk Behavior:
  • Excluded:
  • Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or 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

Miami, Florida, United States

Coral Gables, Florida, United States

Memphis, Tennessee, United States

Chicago, Illinois, United States

Beverly Hills, California, United States

Washington, District Of Columbia, United States

Maitland, Florida, United States

Brookline, Massachusetts, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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