Completed

Rifabutin Regimen for Mycobacterium-Avium Complex (MAC) Bacteremia in AIDS Patients

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What is being tested

Rifabutin

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

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

This clinical trial focuses on treating a specific type of infection called Mycobacterium-Avium Complex (MAC) bacteremia in patients living with AIDS. The main goal is to find out if a medication regimen that includes a drug named rifabutin can eliminate or reduce the number of MAC organisms in the blood. This study also aims to improve symptoms related to MAC infection and increase the survival rate of AIDS patients dealing with this infection. The safety of the drug regimen is another important aspect being evaluated in this study.

NCT00001995
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

5 inclusion criteria required to participate
Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry
Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB)
Diagnosis of AIDS as defined by the CDC
If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry
Show More Criteria
5 exclusion criteria prevent from participating
Antiretroviral drugs, other than zidovudine (AZT) or ddI within 4 weeks
Investigational drugs, other than ddI within 4 weeks
Known hypersensitivity to any of the study drugs
Other therapy for mycobacterial disease
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 22 locations

Maricopa County Med Ctr

Phoenix, United StatesOpen Maricopa County Med Ctr in Google Maps

Bay Harbor Hosp

Harbor City, United States

Ctr for Special Immunology

Irvine, United States

Southwest Community Based AIDS Treatment Group - COMBAT

Los Angeles, United States
Completed22 Study Centers