A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS

NCT00000644 | Completed Phase 2

• 1 other identifier: ACTG 157
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to evaluate the efficacy and safety of clarithromycin given orally at 1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients with AIDS. Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients. Clarithromycin, a new macrolide antimicrobial agent, has demonstrated activity against MAC both in the laboratory and in animals. Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients.

Conditions

Mycobacterium Avium-intracellulare Infection; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Mycobacterium avium-intracellulare Infection; Acquired Immunodeficiency Syndrome; Clarithromycin

Interventions

Clarithromycin DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Didanosine (ddI).
• Dideoxycytidine (ddC).
• Zidovudine (AZT).
• Acetaminophen.
• Acyclovir.
• Fluconazole.
• Erythropoietin (EPO).
• Systemic Pneumocystis carinii pneumonia (PCP) prophylaxis (aerosolized or oral pentamidine, trimethoprim / sulfamethoxazole, or dapsone).
• Maintenance ganciclovir therapy (permitted only if dose and clinical and laboratory parameters have been stable for at least 4 weeks prior to study entry).
• Maintenance treatment for other opportunistic infections if the dose and clinical and laboratory parameters have been stable for 4 weeks prior to study entry.
• Patients must have:
• Positive results for HIV by ELISA confirmed by another method.
• Positive blood culture for Mycobacterium avium complex within 2 months of study entry and clinical symptoms of MAC infection.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Active opportunistic infections. Maintenance treatment for other opportunistic infections will be permitted if the dose and clinical and laboratory parameters have been stable for 4 weeks prior to study entry.
• Concurrent Medication:
• Excluded:
• Aminoglycosides.
• Ansamycin (rifabutin).
• Quinolones.
• Other macrolides.
• Clofazimine.
• Cytotoxic chemotherapy.
• Rifampin.
• Ethambutol.
• Immunomodulators (except alpha interferon).
• Investigational drugs (except ddI, ddC, and erythropoietin).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Abbott: collaborator

Study Sites (3)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• Chaisson RE, Benson CA, Dube MP, Heifets LB, Korvick JA, Elkin S, Smith T, Craft JC, Sattler FR. Clarithromycin therapy for bacteremic Mycobacterium avium complex disease. A randomized, double-blind, dose-ranging study in patients with AIDS. AIDS Clinical Trials Group Protocol 157 Study Team. Ann Intern Med. 1994 Dec 15;121(12):905-11. doi: 10.7326/0003-4819-121-12-199412150-00001.

  PMID: 7978715 BACKGROUND

• Wu AW, Lichter SL, Richardson W, Urbanski PA, Benson C, Sattler FR, Chaisson R. Quality of life in patients receiving clarithromycin for Mycobacterium avium complex infection and AIDS. Int Conf AIDS. 1992 Jul 19-24;8(2):B178 (abstract no PoB 3550)

  BACKGROUND

• Chaisson RE, Benson CA, Dube M, Hafner R, Dellerson M, Lichter S, Smith T, Sattler FR. Clarithromycin for disseminated Mycobacterium avium-complex in AIDS patients. Int Conf AIDS. 1992 Jul 19-24;8(1):We54 (abstract no WeB 1052)

  BACKGROUND

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection; HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Chaisson R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: November 1, 1997
• Last Updated: February 25, 2011

Record last verified: 2011-02

Locations

US (3)