To compare the survival and treatment responses to antiretroviral therapy between HIV-1-infected patients with active TB (TB patients) and without (non-TB patients) in the era of highly active antiretroviral therapy (HAART). 8-year prospective observational study at a university hospital. A total of 125 (17.5%) TB patients (median CD4 cell count at TB diagnosis, 37 x 10(6) cells/l) and 591 non-TB patients (CD4 cell count at enrolment, 79 x 10(6) cells/l) were prospectively observed between June 1994 and October 2002. Virologic and immunologic responses were assessed in 230 antiretroviral-naive non-TB patients and 46 TB patients who concurrently initiated antituberculous therapy and HAART. The clinical outcome was evaluated by comparing incidence of new AIDS-associated opportunistic illnesses (OIs) and survival of all TB and non-TB patients. RESULTS Among antiretroviral-naive patients, CD4 cell count increase (71 versus 64 x 10(6) cells/l, P = 0.70) and proportions of patients achieving undetectable plasma viral load [20 of 46 versus 107 of 230, relative risk (RR), 0.93; 95% confidence interval (95% CI), 0.65-1.34; P = 0.71] at week 4 of HAART were similar between the 46 TB and 230 non-TB patients, as was the virologic failure during HAART (RR, 1.49; 95% CI, 0.92-2.41; P = 0.14). The risk for HIV progression to new OIs was also similar between the two groups (adjusted RR, 1.16; 95% CI, 0.764-1.77). The adjusted hazard ratio for death of TB patients compared with non-TB patients was 1.18 (95% CI, 0.65-2.32) before HAART era and 0.89 (95% CI, 0.57-1.69) in HAART era. Our data indicated that virologic, immunologic, and clinical responses to HAART and prognosis of HIV-1-infected TB patients who were concurrently treated with antituberculous therapy and HAART were similar to those of non-TB patients.