NCT00002331

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1994

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1994

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1995

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

January 16, 2015

Status Verified

February 1, 2009

Enrollment Period

1.2 years

First QC Date

November 2, 1999

Last Update Submit

January 15, 2015

Conditions

Mycobacterium Avium-intracellular InfectionHIV Infections

Keywords

Mycobacterium avium-intracellular InfectionDrug Therapy, CombinationEthambutolClofazimineAcquired Immunodeficiency SyndromeClarithromycin

Interventions

Ethambutol hydrochlorideDRUG
ClarithromycinDRUG
ClofazimineDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Kaiser Permanente Med Ctr

Los Angeles, California, 90027, United States

Location

UCD Med Ctr

Sacramento, California, 95817, United States

Location

Kaiser Permanente Med Ctr

San Francisco, California, 94115, United States

Location

Santa Clara Valley Med Ctr

San Jose, California, 951282699, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Dr Margaret Fischel

Miami, Florida, 33136, United States

Location

Saint Joseph's Hosp / Infectious Disease Rsch Institute

Tampa, Florida, 33614, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Tulane Univ Med School

New Orleans, Louisiana, 701122699, United States

Location

Johns Hopkins Univ School of Medicine

Baltimore, Maryland, 21205, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Univ of North Carolina School of Medicine

Chapel Hill, North Carolina, 275997215, United States

Location

Dr Stephen Hauptman

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt Univ School of Medicine

Nashville, Tennessee, 37212, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Houston Veterans Administration Med Ctr

Houston, Texas, 77030, United States

Location

Dr Javier Morales

Condado San Juan, 00907, Puerto Rico

Location

Related Publications (1)

  • 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. doi: 10.1097/00002030-199703110-00008.

    PMID: 9147422BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

EthambutolClarithromycinClofazimine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsErythromycinMacrolidesPolyketidesLactonesPhenazinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

January 1, 1994

Primary Completion

March 1, 1995

Study Completion

March 1, 1995

Last Updated

January 16, 2015

Record last verified: 2009-02

Locations

US(17)PR(1)