Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Prior Medication: Required:
• • At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy.
• Patients must have:
• • HIV seropositivity.
• • Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
• • CD4 count \> 50 to \<= 300 cells/mm3.
• • Life expectancy of at least 6 months.
• • Prior AZT therapy.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
• • Known intolerance to Ro 31-8959, AZT, or ddC.
• • Symptoms suggestive of pancreatitis.
• • Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding.
• • Visceral Kaposi's sarcoma.
• • Lymphoma that will require therapy within the next 6 months.
• • Transfusion dependence.
• Concurrent Medication:
• Excluded:
• • Investigational or antineoplastic agents.
• Concurrent Treatment:
• Excluded:
• • Radiotherapy (other than local skin radiotherapy).
• • Transfusions.
• Prior Medication:
• Excluded:
• • Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days prior to study entry.
• • Prior treatment with an HIV proteinase inhibitor.

Trial Officials