Objective: To determine the incidence of paradoxical
worsening of tuberculosis (TB) in HIV-infected persons.
Design: Observational cohort study.
Setting: Public, urban TB clinic.
Patients: HIV-infected persons treated for TB between
January 1, 1996, and December 31, 1999, and followed through June 30,
Intervention: Patients received
standard anti-TB therapy. Antiretroviral therapy was provided by
primary medical providers. Patients receiving antiretroviral therapy
were given nucleoside reverse transcriptase inhibitors alone or highly
active antiretroviral therapy (HAART; nucleoside reverse transcriptase
inhibitors in combination with a protease inhibitor or a nonnucleoside
reverse transcriptase inhibitor).
measure: Paradoxical worsening of TB.
There were 82 TB cases in 76 patients. Paradoxical worsening was
identified in 6 of 82 cases (7%; 95% confidence interval, 3 to 15%).
Paradoxical worsening occurred in 3 of 28 cases (11%) in patients
receiving HAART and in 3 of 44 cases (7%) in patients not receiving
antiretroviral therapy (p = 0.67). Cases complicated by paradoxical
worsening were more likely to have both pulmonary and extrapulmonary
disease at initial diagnosis than cases without paradoxical worsening
(83% vs 24%; p = 0.006). TB relapse occurred in 2 of 6 cases (33%)
in patients with paradoxical worsening and in 4 of 76 cases (5%) in
patients without paradoxical worsening (p = 0.06).
Conclusions: Paradoxical worsening of TB occurred less
frequently than in previous reports and was not associated with HAART.
Paradoxical worsening also appeared to be associated with an increased
risk of TB relapse. Further studies are warranted to better
characterize the risk factors for paradoxical worsening and the
appropriate duration of anti-TB therapy in patients in whom it