Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

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Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed for Hematologic toxicity:
• • Erythropoietin.
• • Colony-Stimulating Factors.
• * Allowed for prophylaxis of Pneumocystis carinii pneumonia (PCP):
• • Aerosolized pentamidine.
• • Trimethoprim/sulfamethoxazole.
• • Dapsone.
• * NOTE:
• • If intravenous pentamidine is required for treatment of PCP, study drug should be suspended until one week after completion of intravenous pentamidine.
• * Allowed:
• • Prophylactic or suppressive therapy begun prior to study entry with the exception of neurotoxic agents (as defined in the protocol).
• Concurrent Treatment:
• Allowed:
• • Transfusions for hematologic toxicity.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Active acute AIDS defining infection.
• • Clinical evidence of acute pancreatitis in the last two years or chronic pancreatitis.
• • Dementia of such severity that patient cannot give informed consent.
• • Grade 2 or worse peripheral neuropathy as defined by Targeted Neuropathy Score (Schaumberg).
• • Prior Cytomegalovirus disease requiring ongoing systemic ganciclovir therapy.
• • Extensive Kaposi's sarcoma or other malignancy requiring systemic cytotoxic myelosuppressive or neurotoxic chemotherapy.
• • Cardiomyopathy or the need for antiarrhythmic therapy.
• • Inability to tolerate at least 600 mg per day of zidovudine (AZT).
• • Seizures within the last 6 months or the need for anticonvulsant therapy.
• Concurrent Medication:
• Excluded:
• • Ganciclovir (DHPG).
• • Myelosuppressive or neurotoxic chemotherapy.
• • Antiarrhythmic therapy.
• • Anticonvulsant therapy.
• • Neurotoxic agents (as defined in the protocol).
• * NOTE:
• • If intravenous pentamidine is required for treatment of Pneumocystis carinii pneumonia (PCP), study drug should be suspended until 1 week after completion of intravenous pentamidine.
• Patients with the following are excluded:
• • Symptoms and conditions defined in the Patient Exclusion Co-Existing Conditions field.
• • Average of two sequential CD4 counts from SciCor Clinical Laboratories in the 30 days prior to study entry \> 300 cells/mm3.
• Prior Medication:
• Excluded, participation in studies using:
• • Dideoxyinosine (ddI).
• • 2',3'-Dideoxy-2',3'-didehydrothymidine (d4T).
• • Dideoxycytidine (ddC).
• * Excluded within one month of study entry:
• • Any other experimental antiretroviral compounds.
• Patients must:
• • Have documented HIV positivity via ELISA.
• • Meet CDC criteria for AIDS or AIDS related complex (ARC).
• • Have received zidovudine (AZT) for = or \> 6 months and tolerated a dose of at least 500 mg per day without significant hematologic toxicity.
• • Have no acute AIDS defining opportunistic infection, but may be receiving suppressive therapy for such infections.
• * Demonstrate at least one of the following criteria for clinical deterioration despite AZT therapy within 4 weeks prior to study entry (8 weeks prior for weight loss):
• • involuntary weight loss of more than 5 percent of the body weight occurring over the 8 week period prior to study entry, Karnofsky score = or \> 50 but demonstrating a fall = or \> 20 from previous level of functioning (assessment must be persistent on two occasions at least 14 days apart), unexplained fever of = or \> 38 degrees C (despite evaluation defined in protocol) for more than 7 days, appearance of newly diagnosed oral hairy leukoplakia or oral candidiasis, or recurrence of a previously quiescent multidermatomal varicella-zoster, appearance of dermatologic afflictions (e.g. psoriasis, molluscum contagiosum, or newly diagnosed seborrheic dermatitis), appearance of chronic herpetic ulcers not responsive to acyclovir therapy.
• Required:
• • Zidovudine (AZT) for = or \> 6 months prior to study entry.

Trial Officials