Status:
COMPLETED
A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Avium-intracellulare Infection
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. \[Per 03/06/92 amendm...
Detailed Description
Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particul...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
December 1 1994
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00000641
End Date
December 1 1994
Last Update
November 3 2021
Active Locations (16)
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1
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502
2
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
3
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
4
Washington U CRS
St Louis, Missouri, United States