Completed
Rifapentine Monotherapy and Combination Treatment in AIDS Patients With Mycobacterium Avium Complex Bacteremia
What is being tested
Rifapentine
+ Ethambutol hydrochloride
+ Clarithromycin
Drug
Who is being recruted
Blood-Borne Infections+26
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorAnderson Clinical Research
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This open-label, sequential study is conducted in two parts: a monotherapy phase and a combination treatment phase. In the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy. In the combination treatment phase, 12 patients each are randomized to one of three arms: Arm I: Rifapentine (assigned dose level based on monotherapy phase) plus azithromycin. Arm II: Rifapentine (assigned dose level) plus clarithromycin. Arm III: Rifapentine (assigned dose level) plus ethambutol.
Principal SponsorAnderson Clinical Research
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.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 DiseasesInfectionsInflammationMycobacterium InfectionsMycobacterium Infections, NontuberculousOpportunistic InfectionsPathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsSystemic Inflammatory Response SyndromeSepsisMycobacterium avium-intracellulare InfectionHIV InfectionsBacteremiaAIDS-Related Opportunistic Infections
Criteria
6 inclusion criteria required to participate
Life expectancy of at least 3 months.
Documented AIDS.
MAC prophylaxis with medications other than study drugs (5-day washout period required).
Documented positive HIV serology status.
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12 exclusion criteria prevent from participating
Previous episode of uveitis.
Pulmonary tuberculosis.
Any investigational drug during the 4 weeks prior to randomization.
Treatment for pulmonary TB.
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
Hampton Roads Med Specialists
Hampton, United StatesOpen Hampton Roads Med Specialists in Google MapsCompletedOne Study Center