Completed
Rifabutin or Rifabutin-Ethambutol Combination for MAC Bacteremia Prophylaxis in AIDS Patients with Low CD4 Counts
Study Aim
This study aims to evaluate the effectiveness of Rifabutin or a combination of Rifabutin and Ethambutol in preventing MAC bacteremia in AIDS patients with low CD4 counts.
What is being tested
Ethambutol hydrochloride
+ Rifabutin
Drug
Who is being recruted
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+24 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Summary
Principal SponsorPharmacia
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.
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
200 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 18 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
10 inclusion criteria required to participate
AIDS
AZT, d4T, ddI, or ddC
Antipneumocystis prophylaxis
Antipneumocystis prophylaxis for at least 4 weeks prior to study entry
Show More Criteria
14 exclusion criteria prevent from participating
Active M. tuberculosis
All investigational drugs
Amikacin within 4 weeks prior to study entry
Ciprofloxacin within 4 weeks prior to study entry
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 1 location
Univ of California - Davis Med Ctr / CARES
Sacramento, United StatesOpen Univ of California - Davis Med Ctr / CARES in Google MapsCompletedOne Study Center