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The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycobacterium Avium-intracellulare Infection; HIV Infections

Intervention: Clarithromycin (Drug); Rifabutin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Benson CA, Study Chair
Cohn DL, Study Chair

Summary

To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions. Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.

Clinical Details

Official title: A Prospective, Randomized, Comparative Study of the Safety and Efficacy of Clarithromycin Versus Rifabutin Versus the Combination of Clarithromycin Plus Rifabutin for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia or Disseminated MAC Disease in HIV-Infected Patients With CD4 Lymphocyte Counts <= 100 Cells/mm3

Study design: Primary Purpose: Treatment

Detailed description: Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment. Patients are randomized to receive clarithromycin alone, rifabutin alone, or the two drugs in combination daily. Patients are evaluated every 4 weeks for the first 8 weeks and every 8 weeks thereafter for the duration of the study. Patients are followed for 24 months. Per amendment, a pharmacokinetic substudy will be conducted.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria Concurrent Medication: Recommended:

- PCP prophylaxis.

Allowed:

- GM-CSF or G-CSF.

- Erythropoietin.

- Therapies (including antiretrovirals) available through expanded access or treatment

IND programs.

- Other non-experimental therapies available by prescription.

- Antihistamines other than those specifically excluded.

Patients must have:

- Evidence or diagnosis of HIV infection or a history of an AIDS-defining condition by

CDC criteria.

- CD4 count <= 100 cells/mm3 within 90 days prior to study entry.

- Two baseline blood sample cultures negative for MAC within 30 days of study entry.

- No suspected disseminated MAC disease, in the opinion of the clinician.

NOTE:

- Patients with elevated GGT and/or triglycerides are allowed.

NOTE:

- Patients may co-enroll on ACTG 081/981/181, ACTG 175, ACTG 204, ACTG 193, ACTG 241,

or other acceptable protocols. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:

- Known or suspected tuberculous infection or other non-tuberculous mycobacterial

infection requiring chemotherapy or chemoprophylaxis (with the exception of isoniazid prophylaxis alone). NOTE:

- Patients may enroll who successfully completed tuberculosis (TB) treatment and have

been off anti-TB drugs for more than 6 months with no symptoms of mycobacterial infection.

- Active TB.

- Known hypersensitivity to study drugs.

- Malabsorption as defined by persistent diarrhea with more than 8 stools per day for >

6 weeks. Concurrent Medication: Excluded:

- Frequent (more than once per month), repeated, or continuous treatment courses of

quinolones, erythromycin, spiramycin, azithromycin, clarithromycin, or clindamycin.

- Concomitant terfenadine or astemizole.

Prior Medication: Excluded:

- Prophylaxis with azithromycin, clarithromycin, or rifabutin for more than 4 months.

Locations and Contacts

Mbeya Med. Research Program, Mbeya Referral Hosp. CRS, Mbeya, Tanzania

Alabama Therapeutics CRS, Birmingham, Alabama 35294, United States

UCLA CARE Center CRS, Los Angeles, California 90095, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab., Oakland, California 94609, United States

Ucsf Aids Crs, San Francisco, California, United States

Howard University Hosp., Div. of Infectious Diseases, ACTU, Washington, District of Columbia 20059, United States

Univ. of Miami AIDS CRS, Miami, Florida 33136, United States

Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii 96816, United States

Chicago Children's CRS, Chicago, Illinois 60611, United States

Cook County Hosp. CORE Ctr., Chicago, Illinois 60612, United States

Northwestern University CRS, Chicago, Illinois 60611, United States

Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois 60612, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana 46202, United States

Methodist Hosp. of Indiana, Indianapolis, Indiana 46202, United States

Univ. of Iowa Healthcare, Div. of Infectious Diseases, Iowa City, Iowa 52242, United States

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland 21287, United States

Beth Israel Deaconess - East Campus A0102 CRS, Boston, Massachusetts 02215, United States

Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston, Massachusetts 02215, United States

Bmc Actg Crs, Boston, Massachusetts 02118, United States

Massachusetts General Hospital ACTG CRS, Boston, Massachusetts 02114, United States

Hennepin County Med. Ctr., Div. of Infectious Diseases, Minneapolis, Minnesota 55415, United States

University of Minnesota, ACTU, Minneapolis, Minnesota 55455, United States

St. Louis ConnectCare, Infectious Diseases Clinic, St Louis, Missouri, United States

Washington U CRS, St. Louis, Missouri, United States

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr., Omaha, Nebraska 68198, United States

Bronx-Lebanon Hosp. IMPAACT CRS, Bronx, New York 10457, United States

SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York 14215, United States

Beth Israel Med. Ctr. (Mt. Sinai), New York, New York 10029, United States

Cornell University A2201, New York, New York, United States

Memorial Sloan-Kettering Cancer Ctr., New York, New York 10021, United States

NY Univ. HIV/AIDS CRS, New York, New York 10016, United States

Univ. of Rochester ACTG CRS, Rochester, New York 14642, United States

Unc Aids Crs, Chapel Hill, North Carolina 27599, United States

Carolinas HealthCare System, Carolinas Med. Ctr., Charlotte, North Carolina 28203, United States

Regional Center for Infectious Disease, Wendover Medical Center CRS, Greensboro, North Carolina 27401, United States

Univ. of Cincinnati CRS, Cincinnati, Ohio 45267, United States

Case CRS, Cleveland, Ohio 44106, United States

MetroHealth CRS, Cleveland, Ohio 44109, United States

The Ohio State Univ. AIDS CRS, Columbus, Ohio 43210, United States

Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania 19104, United States

The Children's Hosp. of Philadelphia IMPAACT CRS, Philadelphia, Pennsylvania 19104, United States

University of Washington AIDS CRS, Seattle, Washington 98122, United States

Additional Information

Related publications:

Currier JS, Williams P, Feinberg J, Becker S, Owens S, Benson CA. ACTG 815: a prospective study of bacterial infections in advanced HIV disease. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:131 (abstract no 364)

Mascolini M. FDA advisory committee deadlocks on delavirdine. Food and Drug Administration. AIDS Treat News. 1996 Dec 6;(No 260):3-5.

Watts DH, Spino C, Benson C, Yu B, Katzenstein D, Hammer S, Stratton P, Korvick J. A comparison of gynecologic findings in HIV-positive women with CD4 lymphocyte counts 200 to 500/cc and less than 100/cc. Int Conf AIDS. 1996 Jul 7-12;11(2):275 (abstract no ThB4137)

Fichtenbaum CJ, Zackin R, Feinberg J, Benson C, Griffiths JK; AIDS Clinical Trials Group New Works Concept Sheet Team 064. Rifabutin but not clarithromycin prevents cryptosporidiosis in persons with advanced HIV infection. AIDS. 2000 Dec 22;14(18):2889-93.

Cohn DL. Prevention strategies for Mycobacterium avium-intracellulare complex (MAC) infection. A review of recent studies in patients with AIDS. Drugs. 1997;54 Suppl 2:8-15; discussion 28-9. Review.

Watts DH, Spino C, Zaborski L, Katzenstein D, Hammer S, Benson C. Comparison of gynecologic history and laboratory results in HIV-positive women with CD4+ lymphocyte counts between 200 and 500 cells/microl and below 100 cells/microl. J Acquir Immune Defic Syndr Hum Retrovirol. 1999 Apr 15;20(5):455-62.

Fichtenbaum CJ, Powderly WG. Refractory mucosal candidiasis in patients with human immunodeficiency virus infection. Clin Infect Dis. 1998 Mar;26(3):556-65. Review.

Benson CA, Williams PL, Cohn DL, Becker S, Hojczyk P, Nevin T, Korvick JA, Heifets L, Child CC, Lederman MM, Reichman RC, Powderly WG, Notario GF, Wynne BA, Hafner R. Clarithromycin or rifabutin alone or in combination for primary prophylaxis of Mycobacterium avium complex disease in patients with AIDS: A randomized, double-blind, placebo-controlled trial. The AIDS Clinical Trials Group 196/Terry Beirn Community Programs for Clinical Research on AIDS 009 Protocol Team. J Infect Dis. 2000 Apr;181(4):1289-97. Epub 2000 Apr 13.

Currier JS, Williams P, Feinberg J, Becker S, Owens S, Fichtenbaum C, Benson C; Adult Clinical Trial Group. Impact of prophylaxis for Mycobacterium avium complex on bacterial infections in patients with advanced human immunodeficiency virus disease. Clin Infect Dis. 2001 Jun 1;32(11):1615-22. Epub 2001 Apr 30.


Last updated: June 2, 2015

Page last updated: August 23, 2015

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