Search / Trial NCT00002199

A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.

Launched by GLAXO WELLCOME · Aug 30, 2001

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Trial Information

Current as of December 26, 2024

Completed

Keywords

Hiv 1 Drug Therapy, Combination Zidovudine Drug Resistance, Microbial Hiv Protease Inhibitors Lamivudine Indinavir Genotype Phenotype Reverse Transcriptase Inhibitors Anti Hiv Agents Abacavir

ClinConnect Summary

In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA \>= 400 copies/ml (by PCR on two occasions \>= 1 week and \< 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir.

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • • GM-CSF, G-CSF, and erythropoietin.
  • Concurrent Treatment:
  • Allowed:
  • • Local treatment for Kaposi's sarcoma.
  • Patients must have:
  • • HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.
  • • CD4+ cell count \>= 100 cells/mm3 within 14 days prior to study drug administration.
  • • HIV-1 RNA \>= 10,000 copies/ml within 14 days prior to study drug administration.
  • • No active diagnosis of AIDS according to the 1993 Centers for Disease Control (CDC) AIDS surveillance definition (excluding CD4+ cell counts \< 200 cells/mm3).
  • • Signed, informed consent from parent or legal guardian for patients under 18 years of age.
  • • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • • Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
  • • Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that would compromise the safety of the patient.
  • Concurrent Medication:
  • Excluded:
  • • Cytotoxic chemotherapeutic agents.
  • • Agents with documented anti-HIV-1 activity in vitro.
  • • Foscarnet.
  • • Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, or interferons.
  • • Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine.
  • Concurrent Treatment:
  • Excluded:
  • • Radiation therapy.
  • * Other investigational treatments. NOTE:
  • • Treatments available through treatment IND or other expanded access programs are the exception and evaluated individually.
  • Patients with the following prior conditions are excluded:
  • • History of relevant pancreatitis or hepatitis in the last 6 months.
  • Prior Medication:
  • Excluded:
  • • Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
  • • Prior antiretroviral therapy.
  • • HIV vaccine dose within 90 days of study drug administration.
  • • Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study entry.
  • Prior Treatment:
  • Excluded:
  • • Radiation therapy within 30 days of study drug administration.
  • • Current alcohol or illicit drug use that may interfere with patient compliance.

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

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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