Completed

Clarithromycin/Ethambutol Regimen with Rifabutin or Placebo for MAC Bacteremia in AIDS

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ethambutol hydrochloride

+ Clarithromycin

+ Rifabutin

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorPharmacia
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

NCT00002101
Principal SponsorPharmacia
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

450 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycobacterium InfectionsMycobacterium Infections, NontuberculousRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsAcquired Immunodeficiency SyndromeMycobacterium avium-intracellulare InfectionHIV Infections

Criteria

4 inclusion criteria required to participate
Allowed concurrent medication: Isoniazid for TB prophylaxis ONLY
HIV infection
Life expectancy of at least 16 weeks
MAC infection
5 exclusion criteria prevent from participating
Excluded concurrent medication: Antimycobacterial drugs other than the study drugs, carbamazepine, terfenadine, theophylline
Excluded prior medication within 14 days prior to study entry: Carbamazepine, terfenadine, theophylline
Excluded prior medication within 7 days prior to study entry: Rifabutin, rifampin, ethionamide, cycloserine, clofazimine, ethambutol, amikacin, ciprofloxacin, ofloxacin, sparfloxacin, azithromycin, clarithromycin, pyrazinamide
History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 44 locations

McDowell Clinic

Phoenix, United StatesOpen McDowell Clinic in Google Maps

Maricopa Med Research Foundation

Phoenix, United States

Bay Harbor Hosp

Harbor City, United States

Ctr for Special Immunology

Irvine, United States
Completed44 Study Centers