       Document 0684
 DOCN  M9610684
 TI    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.
 DT    9601
 AU    Schwander S; Rusch-Gerdes S; Mateega A; Lutalo T; Tugume S; Kityo C;
       Rubaramira R; Mugyenyi P; Okwera A; Mugerwa R; et al; Clinical
       Department Bernhard Nocht Institute for Tropical; Medicine, Hamburg,
       Germany.
 SO    Tuber Lung Dis. 1995 Jun;76(3):210-8. Unique Identifier : AIDSLINE
       MED/96014888
 AB    SETTING: 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.
       DESIGN: 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.
       CONCLUSION: 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.
 DE    Adult  Antibiotics, Combined/*THERAPEUTIC USE  Antitubercular
       Agents/*THERAPEUTIC USE  AIDS-Related Opportunistic Infections/*DRUG
       THERAPY  Female  Human  *HIV-1  Male  Mycobacterium
       tuberculosis/ISOLATION & PURIF  Pilot Projects  Retrospective Studies
       Rifabutin/*THERAPEUTIC USE  Rifampin/*THERAPEUTIC USE  Single-Blind
       Method  Sputum/MICROBIOLOGY  Support, Non-U.S. Gov't  Tuberculosis,
       Pulmonary/*DRUG THERAPY  CLINICAL TRIAL  JOURNAL ARTICLE  RANDOMIZED
       CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

