A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS

Inclusion Criteria

• •Concurrent Medication:
• •Allowed:
• •Didanosine (ddI).
• •Dideoxycytidine (ddC).
• •Zidovudine (AZT).
• •Acetaminophen.
• •Acyclovir.
• •Fluconazole.
• •Erythropoietin (EPO).
• •Systemic Pneumocystis carinii pneumonia (PCP) prophylaxis (aerosolized or oral pentamidine, trimethoprim / sulfamethoxazole, or dapsone).
• •Maintenance ganciclovir therapy (permitted only if dose and clinical and laboratory parameters have been stable for at least 4 weeks prior to study entry).
• •Maintenance treatment for other opportunistic infections if the dose and clinical and laboratory parameters have been stable for 4 weeks prior to study entry.
• •Patients must have:
• •Positive results for HIV by ELISA confirmed by another method.
• •Positive blood culture for Mycobacterium avium complex within 2 months of study entry and clinical symptoms of MAC infection.
• •Discontinued all mycobacterial drugs (approved and investigational) for at least 4 weeks prior to the start of drug therapy (with the exception of isoniazid prophylaxis which should be discontinued at Study Day minus 14 to Study Day minus 7
• •Given written informed consent to participate in the trial.
• •Met the listed laboratory parameters in the pre-treatment visit.
• •Prior Medication:
• •Allowed:
• •Didanosine (ddI).
• •Deoxycytidine (ddC).
• •Zidovudine (AZT).
• •Acetaminophen.
• •Acyclovir.
• •Fluconazole.
• •Erythropoietin (EPO).
• •Systemic Pneumocystis carinii pneumonia (PCP) prophylaxis (aerosolized or oral pentamidine, dapsone, trimethoprim / sulfamethoxazole).
• •Maintenance ganciclovir therapy (permitted only if dose and clinical and laboratory parameters have been stable for at least 4 weeks prior to study entry).