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The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: Ethambutol hydrochloride (Drug); Clarithromycin (Drug); Clofazimine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Abbott

Summary

PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.

Clinical Details

Official title: A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS

Study design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria Patients must have:

- History of HIV seropositivity.

- Disseminated MAC.

- Positive blood culture for MAC within 4 weeks prior to study entry.

- Consent of parent or guardian if less than 18 years of age.

- Ability to complete the study.

NOTE:

- Patients with active opportunistic infections other than dMAC are permitted if dosage

and clinical parameters have been stable for 4 weeks prior to enrollment. Exclusion Criteria Concurrent Medication: Excluded:

- Active therapy with carbamazepine or theophylline, unless investigator agrees to

carefully monitor blood levels.

- Active therapy with investigational drugs other than treatment for HIV disease,

except with approval of the sponsor.

- Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).

- Amikacin.

- Azithromycin.

- Capreomycin.

- Ciprofloxacin.

- Cycloserine.

- Ethionamide.

- Gentamicin.

- Kanamycin.

- Levofloxacin.

- Lomefloxacin.

- Ofloxacin.

- Rifampin.

- Rifabutin.

- Sparfloxacin.

- Streptomycin.

- Any other aminoglycosides, quinolones, and macrolides.

Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine. Prior Medication: Excluded:

- Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other

macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.

- Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more

than 14 days cumulative within the past 2 months.

Locations and Contacts

Dr Javier Morales, Condado San Juan 00907, Puerto Rico

Kaiser Permanente Med Ctr, Los Angeles, California 90027, United States

UCD Med Ctr, Sacramento, California 95817, United States

Kaiser Permanente Med Ctr, San Francisco, California 94115, United States

Santa Clara Valley Med Ctr, San Jose, California 951282699, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

Dr Margaret Fischel, Miami, Florida 33136, United States

Saint Joseph's Hosp / Infectious Disease Rsch Institute, Tampa, Florida 33614, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Tulane Univ Med School, New Orleans, Louisiana 701122699, United States

Johns Hopkins Univ School of Medicine, Baltimore, Maryland 21205, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Univ of North Carolina School of Medicine, Chapel Hill, North Carolina 275997215, United States

Dr Stephen Hauptman, Philadelphia, Pennsylvania 19107, United States

Vanderbilt Univ School of Medicine, Nashville, Tennessee 37212, United States

Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States

Houston Veterans Administration Med Ctr, Houston, Texas 77030, United States

Additional Information

Related publications:

Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7.

Starting date: January 1994
Last updated: January 15, 2015

Page last updated: August 23, 2015

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