Search / Trial NCT00002213

The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors

Launched by GLAXO WELLCOME · Aug 30, 2001

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Trial Information

Current as of January 03, 2025

Completed

Keywords

Hiv 1 Drug Therapy, Combination Antiviral Agents Hiv Protease Inhibitors Rna, Viral Vx 478 Anti Hiv Agents Abacavir Efavirenz

ClinConnect Summary

This is a multicenter, open-label study. A total of 80 patients are treated on this study and include:

At least 30 patients with a viral burden of 500 - 40,000 copies/ml. At least 30 patients with a viral burden greater than 40,000 copies/ml. At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors (NRTIs).

All patients receive self-administered, combination antiretroviral therapy for 48 weeks, as follows:

1592U89 plus 141W94 plus DMP 266.

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • • Hematologic supportive therapy with GM-CSF, G-CSF, or erythropoietin.
  • * Drugs that may interact with CYP3A4, that should be used with caution including (but not limited to):
  • • alprazolam, carbamazepine, codeine, cimetadine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, itraconazole, ketoconazole, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, quinidine, rifabutin, simvastatin, and warfarin.
  • * Detoxification treatment including opiate agonists (methadone, buprenorphine, etc.):
  • • Patients currently receiving this treatment should be enrolled only if stable on this therapy.
  • Patients must have:
  • • HIV-1 infection (all CDC clinical categories allowed).
  • • HIV-1 RNA greater than 500 copies/ml when measured on 1 occasion within 14 days of study drug administration.
  • • Signed, informed consent from parent or legal guardian for those patients under 18 years of age.
  • • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • • Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption or render the patient unable to take oral medication.
  • • Active AIDS-defining opportunistic infection or disease that is likely to preclude the patient from study participation.
  • • Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that, in the opinion of the investigator, would compromise the safety of the patient.
  • Concurrent Medication:
  • Excluded:
  • • Immunomodulating agents, e.g., corticosteroids, interleukins, thalidomide, anti-cytokine agents and interferons.
  • • Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
  • • Anti-oxidants.
  • • Foscarnet therapy or therapy with other agents with documented activity against HIV-1 in vitro.
  • * Medications that interact with 141W94:
  • • terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine-containing regimens.
  • • Vitamin E supplements.
  • • Other investigational treatments (treatments available through Treatment IND or other expanded access mechanism evaluated on an individual basis).
  • Concurrent Treatment:
  • Excluded:
  • • Anticipated need for radiation therapy (with the exception of local treatment for Kaposi's sarcoma).
  • Patients with the following symptoms and conditions are excluded:
  • • History of clinically relevant hepatitis within the previous six months.
  • • History of lymphoma.
  • Prior Medication:
  • Excluded:
  • • Cytotoxic chemotherapeutic agents within 30 days of study drug administration or an anticipated need for such treatment within the next 48 weeks (with exception of local treatment for Kaposi's sarcoma).
  • • Investigational HIV-1 vaccine trial and receipt of a dose of vaccine within the past 3 months.
  • • Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study drug administration.
  • • Exposure to the investigational agents 1592U89, 141W94, or DMP 266 (Sustiva).
  • Prior Treatment:
  • Excluded:
  • • Radiation therapy.
  • Required:
  • * Treatment with at least 1 of the following protease inhibitors (PIs) for a minimum of 20 weeks prior to screening:
  • • indinavir, ritonavir, saquinavir, and/or nelfinavir.
  • • Treatment with the same combination of PIs for the most recent 12 weeks and up through entry on study (Day 1).
  • • Active alcohol or illicit drug use that is likely to interfere with dosing schedule compliance 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

Boston, Massachusetts, United States

Berkeley, California, United States

Los Angeles, California, United States

Chicago, Illinois, United States

Bethesda, Maryland, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Cincinnati, Ohio, United States

Providence, Rhode Island, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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