A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.

Inclusion Criteria

Concurrent Medication:

Allowed:

• Zidovudine (AZT) and didanosine (ddI). Dideoxycytidine (ddC), EPO, and other experimental therapies granted Treatment IND or Expanded Access status, with the exception of rifabutin.
• Concurrent therapies (acute and maintenance) for opportunistic infections not specifically prohibited.

Concurrent Treatment:

Allowed:

• Interferon-alfa.

Patients must have the following:

• HIV infections or diagnosis of AIDS as per CDC classification.
• Mycobacterium avium isolated from blood.
• Capability of signing an informed consent, or consent of guardian if < 18 years of age.
• Ability and willingness to participate in all components of the study and receive all study therapies.

Prior Medication:

Allowed:

• Interferon-alfa.
• Single drug prophylaxis for Mycobacterium avium or M. tuberculosis within the previous 4 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Treatment Phase:

• Known or suspected allergy to any of the study medications. Severe hearing loss.

Maintenance Phase:

• Severe hearing loss. Hypersensitivity to macrolides. Intolerance to ethambutol and clofazimine.

Concurrent Medication:

Excluded:

• Acute therapy for other opportunistic infections at time of study entry.
• Nephrotoxic agents such as amphotericin B, intravenous vancomycin, or foscarnet during the first 4 weeks of study therapy without specific exemption from one of the protocol chairs. Antacids within 2 hours of ingestion of study drugs.
• Immunomodulators (except interferon-alfa) and other antimycobacterial drugs (including quinolones and aminoglycosides).
• All experimental therapies (except ddI, ddC, and other experimental agents granted "Treatment IND" or "expanded access" status) will be prohibited (specific exemptions must be obtained from one of the protocol chairs).

Patients with the following are excluded:

• Known or suspected allergy to any of the study medications. Cannot take drugs orally.
• Severe hearing loss, at the discretion of the investigator.

Prior Medication:

Excluded:

• Antimycobacterial drugs (including azithromycin, clarithromycin, rifamycins, quinolones, and aminoglycosides) or immunomodulators (except interferon-alfa) within 4 weeks prior to entry, except single-drug prophylaxis specifically allowed.

History of unreliable drug intake.

• Inability to cooperate in the testing procedures.

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