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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Timing of antiretroviral therapy for HIV-1 infection and tuberculosis
New England Journal of Medicine, Volume 365, No. 16, Year 2011
Notification
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Description
BACKGROUND: Antiretroviral therapy (ART) is indicated during tuberculosis treatment in patients infected with human immunodeficiency virus type 1 (HIV-1), but the timing for the initiation of ART when tuberculosis is diagnosed in patients with various levels of immune compromise is not known. METHODS: We conducted an open-label, randomized study comparing earlier ART (within 2 weeks after the initiation of treatment for tuberculosis) with later ART (between 8 and 12 weeks after the initiation of treatment for tuberculosis) in HIV-1 infected patients with CD4+ T-cell counts of less than 250 per cubic millimeter and suspected tuberculosis. The primary end point was the proportion of patients who survived and did not have a new (previously undiagnosed) acquired immunodeficiency syndrome (AIDS)-defining illness at 48 weeks. RESULTS: A total of 809 patients with a median baseline CD4+ T-cell count of 77 per cubic millimeter and an HIV-1 RNA level of 5.43 log10 copies per milliliter were enrolled. In the earlier-ART group, 12.9% of patients had a new AIDS-defining illness or died by 48 weeks, as compared with 16.1% in the later-ART group (95% confidence interval [CI], -1.8 to 8.1; P = 0.45). Among patients with screening CD4+ T-cell counts of less than 50 per cubic millimeter, 15.5% of patients in the earlier-ART group versus 26.6% in the later-ART group had a new AIDS-defining illness or died (95% CI, 1.5 to 20.5; P = 0.02). Tuberculosis-associated immune reconstitution inflammatory syndrome was more common with earlier ART than with later ART (11% vs. 5%, P = 0.002). The rate of viral suppression at 48 weeks was 74% and did not differ between the groups (P = 0.38). CONCLUSIONS: Overall, earlier ART did not reduce the rate of new AIDS-defining illness and death, as compared with later ART. In persons with CD4+ T-cell counts of less than 50 per cubic millimeter, earlier ART was associated with a lower rate of new AIDS-defining illnesses and death. (Funded by the National Institutes of Health and others; ACTG A5221 ClinicalTrials.gov number, NCT00108862.) Copyright © 2011 Massachusetts Medical Society. All rights reserved.
Authors & Co-Authors
Havlir, Diane V.
Unknown Affiliation
Kendall, Michelle A.
Unknown Affiliation
Ive, Prudence D.
Unknown Affiliation
Kumwenda, Johnstone J.
Unknown Affiliation
Swindells, Susan N.
Unknown Affiliation
Qasba, Sarojini Sonia
Unknown Affiliation
Luetkemeyer, Anne F.
Unknown Affiliation
Hogg, Evelyn
Unknown Affiliation
Rooney, James F.
Unknown Affiliation
Wu, Xingye
Unknown Affiliation
Hosseinipour, Mina C.
Unknown Affiliation
Lalloo, Umesh Gangaram
Unknown Affiliation
Veloso, V. G.
Unknown Affiliation
Some, Fatma F.
Unknown Affiliation
Kumarasamy, Nagalingeswaran
Unknown Affiliation
Padayatchi, Nesri
Unknown Affiliation
Santos, Breno Riegel
Unknown Affiliation
Reid, Stewart E.
Unknown Affiliation
Hakim, James Gita
Unknown Affiliation
Mohapi, Lerato
Unknown Affiliation
Mugyenyi, Peter N.
Unknown Affiliation
Sánchez, Jorge L.
Unknown Affiliation
Lama, Javier R.
Unknown Affiliation
Pape, Jean William
Unknown Affiliation
Sanchez, Alejandro
Unknown Affiliation
Asmelash, Aida
Unknown Affiliation
Moko, Evans
Unknown Affiliation
Sawe, Fredrick Kipyego
Unknown Affiliation
Andersen, Janet W.
Unknown Affiliation
Sanne, Ian
Unknown Affiliation
Statistics
Citations: 557
Authors: 30
Affiliations: 26
Identifiers
Doi:
10.1056/NEJMoa1013607
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Infectious Diseases