A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.
Ciprofloxacin hydrochloride
+ Ethambutol hydrochloride
+ Amikacin sulfate
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously). Patients undergo an initial 2-week observation period (days 1 - 14) during which time baseline evaluations are performed and type and severity of symptoms are monitored. Eligible patients are randomized on day 15 to one of two treatment programs: (1) ciprofloxacin, clofazimine, ethambutol, and rifampin (all taken orally), or (2) the same four drugs plus amikacin. Only patients for whom blood cultures obtained on either day 1 or day 14/15 are positive by week 6 continue on study drugs. Patients receive combination therapy for 24 weeks. Patients may have an indwelling central venous catheter in place for long-term administration of intravenous drug. PER 03/06/92 AMENDMENT: Newly enrolled patients who demonstrate a complete or partial clinical response at the end of study week 10 (8 weeks of drug therapy) discontinue their current regimen and begin maintenance therapy with azithromycin plus either ethambutol or clofazimine for an additional 24 weeks. Patients who do not demonstrate a response at study week 10 are discontinued from all study therapy. Patients enrolled on earlier versions of the protocol who have surpassed study week 16 (14 weeks of drug therapy) continue treatment with their originally assigned regimen through study week 26; those who have not surpassed study week 16 are considered for inclusion in the maintenance phase of the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 16 locations
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, United StatesSt. Louis ConnectCare, Infectious Diseases Clinic
St Louis, United StatesWashington U CRS
St Louis, United States