Search / Trial NCT00002364

A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 27, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents

ClinConnect Summary

Patients will all receive oral doses of 1592U89 in combination with protocol specific current antiretroviral therapy. The treatment groups will be assigned based on each subject's previous NRTI experience.

The study medication is self administered and all evaluations will be performed on an outpatient basis. Patients will be seen at day 0 and weeks 2, 4, 12, 16, 20 and 24.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • CD4+ cell count \>= 100 /mm3.
  • Plasma HIV RNA \>= 30,000 copies/ml.
  • Study participants may be recruited from all clinical categories, provided they do not meet any of the exclusion criteria.
  • Parent or legal guardian to sign written, informed consent for patients under the age of 18.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with any of the following symptoms or conditions are excluded:
  • * Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE:
  • For this study, a CD4+ cell count \<= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event.
  • Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
  • Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety.
  • Concurrent Medication:
  • Excluded:
  • Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study.
  • Patients receiving other investigational drugs.
  • Foscarnet therapy or therapy with other agents with documented activity against HIV in vitro.
  • Treatment with immunomodulators.
  • Patients on methadone.
  • Concurrent Treatment:
  • Excluded:
  • * Treatment with radiation therapy within the 24 weeks of the study. NOTE:
  • Localized radiation therapy may be permitted following consultation with the sponsor.
  • Patients with any of the following prior conditions are excluded:
  • Subjects with a history of lymphoma.
  • Subjects with a history of clinically apparent pancreatitis or hepatitis within the last 6 months.
  • Prior Medication:
  • Excluded:
  • Treatment with any antiretroviral therapy with NRTIs (alone or in combination) other than those defined for each treatment group.
  • Treatment with any non-nucleoside RT inhibitors or protease inhibitors.
  • Treatment with cytotoxic chemotherapeutic agents within 1 month prior to study entry.
  • Investigational HIV vaccine within the past 3 months.
  • Immunomodulating agents such as systematic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry.
  • Prior Treatment:
  • Excluded:
  • Treatment with radiation therapy within 1 month of entry.
  • Risk Behavior:
  • Excluded:
  • Patients with current alcohol or illicit drug use that, in the opinion of the principal investigator, may interfere with the patient's ability to comply with the study protocol.

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

New York, New York, United States

Atlanta, Georgia, United States

Fort Lauderdale, Florida, United States

San Francisco, California, United States

Greenbrae, California, United States

Lexington, Kentucky, United States

Altamonte Springs, Florida, United States

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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