A Randomized Trial of Punctuated Antiretroviral Therapy in Ugandan HIV-Seropositive Adults With Pulmonary Tuberculosis and CD4⁺ T-Cell Counts of ≥350 cells/µL

• Published in: The Journal of infectious diseases Vol. 204; no. 6; pp. 884 - 892
• Main Authors: Nanteza, M. W., Mayanja-Kizza, H., Charlebois, E., Srikantiah, P., Lin, R., Mupere, E., Mugyenyi, P., Boom, W. H., Mugerwa, R. D., Havlir, D. V., Whalen, C. C.
• Format: Journal Article
• Language: English
• Published: Oxford University Press 15-09-2011
• Subjects: AIDS; Antiretrovirals; Health outcomes; HIV; HIV/AIDS; Mycobacterium tuberculosis; Pulmonary tuberculosis; Research universities; RNA; T lymphocytes; Tuberculosis
• ISSN: 0022-1899; 1537-6613

Background. Optimal treatment of human immunodeficiency virus (HlV)-associated tuberculosis in patients with high CD4⁺ T-cell counts is unknown. Suppression of viral replication during therapy for tuberculosis may block effects of immune activation on T cells and slow HIV disease progression. Methods. We conducted a randomized trial in 214 HIV-infected patients with active tuberculosis and CD4⁺ T-cell counts of ≥350 cells/µL to determine whether 6 months of antiretroviral therapy given during tuberculosis treatment would improve clinical outcomes. Subjects were randomized to receive 6 months of abacavir-lamivudinezidovudine concurrent with tuberculosis therapy or delayed antiretroviral therapy. Endpoints were CD4⁺ T-cell counts of <250 cells/µL, AIDS, or death. Results. Intervention and comparison arms had similar median CD4⁺ counts (517 and 534 cells/µL , respectively) and HIV RNA levels (4.6 and 4.7 log₁₀ copies/µL, respectively). Viral suppression was achieved in 86% of patients allocated to intervention. Seventeen subjects (15.6%) in the intervention arm developed study outcome compared to 25 subjects (22.8%) in the comparison arm (P = .17). Grade 3 or 4 adverse events were less frequent in the intervention arm. By 2 months, 90% of subjects in both arms were culture-negative for tuberculosis. Conclusions. Short-term antiretroviral therapy during tuberculosis treatment in patients with CD4⁺ T-cell counts of >350 cellsµL was safe and associated with clinical benefits.