CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Clarithromycin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001030
NCT00001030Phase 3Completed

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 1, 2021

In Brief

A Phase 3 clinical trial evaluating Clarithromycin and Rifabutin for Mycobacterium Avium-intracellulare Infection and HIV Infections. Completed, across 42 sites in 2 countries.

Detailed Summary

To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTanzania, United States
Collaborators--

Timeline

Phase 3CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Study CompletionJun 1, 1996
TodayJul 2, 2026
Posted 24.8 years ago

Interventions

Clarithromycindrug

Rifabutindrug