Completed

Rifabutin Monotherapy for MAC Bacteremia Prevention in AIDS Patients with Low CD4 Counts

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What is being tested

Rifabutin

Drug
Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+32 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 study focuses on AIDS patients who have CD4 counts of 200 or less. It aims to understand if a drug called rifabutin can help prevent or delay a specific type of infection known as Mycobacterium avium complex (MAC) bacteremia. This infection is a common complication in AIDS patients. The study hopes to find out if rifabutin can improve the health and survival of these patients by reducing the risk of this infection.

NCT00002267
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

750 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, NontuberculousOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsAcquired Immunodeficiency SyndromeMycobacterium avium-intracellulare InfectionHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

6 inclusion criteria required to participate
Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC)

Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant

Antipneumocystis prophylactic therapy

Antipneumocystis prophylaxis

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26 exclusion criteria prevent from participating
Amikacin

Antimycobacterial therapy

Antiretroviral agents other than zidovudine (AZT)

Ciprofloxacin

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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 43 locations

Maricopa County Med Ctr

Phoenix, United StatesOpen Maricopa County Med Ctr in Google Maps

East Bay AIDS Ctr

Berkeley, United States

Pacific Oaks Med Group

Beverly Hills, United States

AIDS Community Research Consortium

Redwood City, United States
Completed43 Study Centers