Completed

A Prospective, Randomized, Comparative Study of the Safety and Efficacy of Clarithromycin Versus Rifabutin Versus the Combination of Clarithromycin Plus Rifabutin for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia or Disseminated MAC Disease in HIV-Infected Patients With CD4 Lymphocyte Counts <= 100 Cells/mm3

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

Clarithromycin

+ Rifabutin

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment. Patients are randomized to receive clarithromycin alone, rifabutin alone, or the two drugs in combination daily. Patients are evaluated every 4 weeks for the first 8 weeks and every 8 weeks thereafter for the duration of the study. Patients are followed for 24 months. Per amendment, a pharmacokinetic substudy will be conducted.

NCT00001030
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
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

1100 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 12 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

Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis. Allowed: GM-CSF or G-CSF. Erythropoietin. Therapies (including antiretrovirals) available through expanded access or treatment IND programs. Other non-experimental therapies available by prescription. Antihistamines other than those specifically excluded. Patients must have: Evidence or diagnosis of HIV infection or a history of an AIDS-defining condition by CDC criteria. CD4 count <= 100 cells/mm3 within 90 days prior to study entry. Two baseline blood sample cultures negative for MAC within 30 days of study entry. No suspected disseminated MAC disease, in the opinion of the clinician. NOTE: Patients with elevated GGT and/or triglycerides are allowed. NOTE: Patients may co-enroll on ACTG 081/981/181, ACTG 175, ACTG 204, ACTG 193, ACTG 241, or other acceptable protocols. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known or suspected tuberculous infection or other non-tuberculous mycobacterial infection requiring chemotherapy or chemoprophylaxis (with the exception of isoniazid prophylaxis alone). NOTE: Patients may enroll who successfully completed tuberculosis (TB) treatment and have been off anti-TB drugs for more than 6 months with no symptoms of mycobacterial infection. Active TB. Known hypersensitivity to study drugs. Malabsorption as defined by persistent diarrhea with more than 8 stools per day for > 6 weeks. Concurrent Medication: Excluded: Frequent (more than once per month), repeated, or continuous treatment courses of quinolones, erythromycin, spiramycin, azithromycin, clarithromycin, or clindamycin. Concomitant terfenadine or astemizole. Prior Medication: Excluded: Prophylaxis with azithromycin, clarithromycin, or rifabutin for more than 4 months.

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 42 locations

Alabama Therapeutics CRS

Birmingham, United StatesOpen Alabama Therapeutics CRS in Google Maps

UCLA CARE Center CRS

Los Angeles, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, United States

Ucsf Aids Crs

San Francisco, United States
Completed42 Study Centers