Search / Trial NCT00002442

A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Drug Therapy, Combination Zidovudine Drug Administration Schedule Stavudine Hiv Protease Inhibitors Lamivudine Indinavir Dosage Forms Nelfinavir Reverse Transcriptase Inhibitors Anti Hiv Agents

ClinConnect Summary

Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Are at least 18 years old.
  • Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.
  • Have a CD4 cell count of at least 50 cells/mm3.
  • Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)
  • Agree to abstain from sex or use effective methods of birth control during the study.
  • Exclusion Criteria
  • Patients will not be eligible for this study if they:
  • Have a history of an AIDS-defining illness or certain other medical conditions.
  • Are allergic to any of the study drugs.
  • Are unable to take medication by mouth for any reason.
  • Have received certain medications.
  • Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.
  • Are pregnant or breast-feeding.

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

Chicago, Illinois, United States

Palo Alto, California, United States

Fort Lauderdale, Florida, United States

Galveston, Texas, United States

New York, New York, United States

Dallas, Texas, United States

Altamonte Springs, Florida, United States

Los Angeles, California, United States

Washington, District Of Columbia, United States

Philadelphia, Pennsylvania, United States

Miami, Florida, 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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