Setting: Patients were enrolled in a prospective trial of rifabutin-based tuberculosis (TB) treatment for human immunodeficiency virus related TB. Antiretroviral therapy (ART) was encouraged, but not required.
Objective: To evaluate the frequency, risk factors and duration of immune reconstitution events.
Design: Patients were prospectively evaluated for immune reconstitution events, and all adverse event reports were reviewed to identify possible unrecognized events.
Results: Of 169 patients, 25 (15%) developed immune reconstitution events related to TB. All 25 were among the 137 patients who received ART during TB treatment, so the frequency in this subgroup was 18% (25/137). Risk factors for an immune reconstitution event in multivariate analysis were Black race, the presence of extra-pulmonary TB and a shorter interval from initiation of TB treatment to initiation of ART. The most common clinical manifestations were fever (64%), new or worsening adenopathy (52%) and worsening pulmonary infiltrates (40%). Twelve patients (48%) were hospitalized for a median of 7 days, six underwent surgery and 11 had needle aspiration. The median duration of events was 60 days (range 11-442).
Conclusion: Immune reconstitution events were common among patients receiving ART during TB treatment, produced substantial morbidity and had a median duration of 2 months.