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).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Active opportunistic infections. Maintenance treatment for other opportunistic infections will be permitted if the dose and clinical and laboratory parameters have been stable for 4 weeks prior to study entry.

Concurrent Medication:

Excluded:

• Aminoglycosides.
• Ansamycin (rifabutin).
• Quinolones.
• Other macrolides.
• Clofazimine.
• Cytotoxic chemotherapy.
• Rifampin.
• Ethambutol.
• Immunomodulators (except alpha interferon).
• Investigational drugs (except ddI, ddC, and erythropoietin).

Patients with the following are excluded:

• History of allergy to macrolide antimicrobials.
• Currently on active therapy with any anti-mycobacterial drugs listed in Exclusion Prior Medications.
• Currently on active therapy with carbamazepine or theophylline, unless the investigator agrees to carefully monitor blood levels.
• Inability to comply with the protocol or judged to be near imminent death by the investigator.
• Active opportunistic infections.
• Requiring any of the excluded concomitant medications.

Prior Medication:

Excluded for at least 4 weeks prior to study entry:

• All anti-mycobacterial drugs (approved and investigational) with the exception of isoniazid prophylaxis, which should be discontinued at Study Day minus 14 to minus 7.