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Effect of HIV infection on tolerability and bacteriologic outcomes of tuberculosis treatment . SETTING Two international , multicenter Phase 2 clinical trials examining fluoroquinolone-containing regimens in adults with smear-positive pulmonary tuberculosis ( TB ) , conducted from July 2003 to March 2007 . Both trials enrolled human immunodeficiency virus ( HIV ) infected participants who were not receiving antiretroviral therapy ( ART ) at TB treatment initiation . OBJECTIVE To assess the impact of HIV infection on TB treatment outcomes in Phase 2 clinical trials . DESIGN Cross-protocol analysis comparing the safety , tolerability and outcomes of anti-tuberculosis treatment by HIV status . RESULTS Of 750 participants who received at least one dose of study treatment , 123 ( 16 % ) were HIV-infected . Treatment completion rates were similar by HIV status ( 81 % infected vs. 85 % non-infected ) , as were rates of week 8 culture conversion ( 66 % infected vs. 63 % non-infected ) , and treatment failure ( 5 % infected vs. 3 % non-infected ) . Among HIV-infected participants , treatment failure detected using liquid media was more frequent in those treated thrice weekly ( 14 % thrice weekly vs. 2 % daily , P = 0.03 ) . HIV-infected participants more frequently experienced an adverse event during the intensive phase treatment than non-HIV-infected participants ( 30 % vs. 15 % , P < 0.01 ) . CONCLUSION HIV-infected persons not receiving ART had more adverse events during the intensive phase of anti-tuberculosis treatment , but tolerated treatment well . Failure rates were higher among HIV-infected persons treated with thrice-weekly intensive phase therapy .
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Intervention_Pharmacological
fluoroquinolone-containing regimens
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Intervention_Pharmacological
anti-tuberculosis treatment
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Outcome_Other
tolerability and bacteriologic outcomes
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Outcome_Other
safety , tolerability and outcomes
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Outcome_Other
Treatment completion rates
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Outcome_Other
treatment failure
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Outcome_Adverse-effects
adverse event
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Outcome_Other
tolerated treatment well .
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Participant_Condition
smear-positive pulmonary tuberculosis ( TB )
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Participant_Condition
human immunodeficiency virus ( HIV ) infected participants who were not receiving antiretroviral therapy ( ART ) at TB treatment initiation .
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Participant_Sample-size
750 participants
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Participant_Condition
HIV-infected
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Participant_Condition
HIV-infected persons