title: A pilot study of antituberculosis combinations comparing rifabutin with rifampicin in the treatment of HIV-1 associated tuberculosis. A single-blind randomized evaluation in Ugandan patients with HIV-1 infection and pulmonary tuberculosis.
abstract: METHODS
  This pilot study was conducted at the Joint Clinical Research Centre (JCRC) in Kampala, Uganda, where tuberculosis (TB) is an epidemic health problem aggravated by the HIV-1 pandemic.
  
  
  OBJECTIVE
  To evaluate the feasibility of a larger phase III trial utilizing rifabutin as a substitute for rifampicin in short-course therapy for pulmonary TB.
  
  
  METHODS
  Single-blind randomized trial in 50 patients with new onset smear- and culture-positive pulmonary tuberculosis and HIV-1 infection. Comparison of daily, intermittently supervised 6-month treatment regimens of rifabutin versus rifampicin, together with isoniazid, ethambutol and pyrazinamide.
  
  
  RESULTS
  Rifabutin- and rifampicin-containing regimens had comparable efficiency. However, rifabutin-treated patients had significantly more rapid clearance of acid-fast bacilli from sputum at 2 months (P < 0.05, Fisher exact test) and over the entire study period (P < 0.05, logrank test) than rifampicin-treated patients. The presence of cavitary disease was associated with a longer sputum conversion time for patients treated with either regimen. No major adverse events requiring dosage reduction or withdrawal of any study medication were seen in either treatment group. Mean absolute peripheral blood CD4 T lymphocyte counts increased by 28% from week 0 to week 12 in all subjects (334-427/microliters, respectively). An unexpected finding was the isolation of Mycobacterium africanum from 49% of the sputum cultures. This is the first report indicating a high prevalence of M. africanum in human TB in Uganda.
  
  
  CONCLUSIONS
  Short-course antituberculosis regimens containing rifabutin or rifampicin are both safe and efficacious in the treatment of HIV-1 associated tuberculosis. Rifabutin-containing regimens were associated with earlier sputum smear and culture conversion.
authors.affiliation: Clinical Department Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Schwander
authors.forename: S
authors.initials: S
authors.lastname: Rüsch-Gerdes
authors.forename: A
authors.initials: A
authors.lastname: Mateega
authors.forename: T
authors.initials: T
authors.lastname: Lutalo
authors.forename: S
authors.initials: S
authors.lastname: Tugume
authors.forename: C
authors.initials: C
authors.lastname: Kityo
authors.forename: R
authors.initials: R
authors.lastname: Rubaramira
authors.forename: P
authors.initials: P
authors.lastname: Mugyenyi
authors.forename: A
authors.initials: A
authors.lastname: Okwera
authors.forename: R
authors.initials: R
authors.lastname: Mugerwa
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D015497:HIV-1; D006801:Humans; D008297:Male; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification; D010865:Pilot Projects; D012189:Retrospective Studies; D017828:Rifabutin / Q000627:therapeutic use*; D012293:Rifampin / Q000627:therapeutic use*; D016037:Single-Blind Method; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents; D017828:Rifabutin; D012293:Rifampin