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A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals. Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals. Clinical research trials and A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals. medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals.. A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals. Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals. clinical trial. Test subjects typically obtain the finest healthcare available for their A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals. condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals.  A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals.
A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals.
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] 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).
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
DMParenti, Study Chair,
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Nassau County Med Ctr
East Meadow, New York, 11554
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of Pittsburgh Med School / Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Huntington Memorial Hosp / Children's Hosp of Los Angeles
Pasadena, California, 91105
United States
Additional Information:
Study ID Numbers: ACTG 135;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000641
Other Mycobacterium Avium-Intracellulare Infection Studies:
1. A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
2. Evaluation of the Therapeutic Benefit of r-metHuIFN- gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
3. A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
4. A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS
5. Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS
Related Studies:
Other Mycobacterium avium-intracellulare Infection Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals.
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