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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety