Show simple item record Shao, HJ Crump, JA Ramadhani, HO Uiso, LO Ole-Nguyaine, S Moon, AM Kiwera, RA Woods, CW Shao, JF Bartlett, JA Thielman, NM
dc.coverage.spatial United States 2012-11-01T19:03:58Z 2009-12
dc.identifier.citation AIDS Res Hum Retroviruses, 2009, 25 (12), pp. 1277 - 1285
dc.description.abstract Fixed dose combination abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) among HIV-1 and tuberculosis (TB)-coinfected patients was evaluated and outcomes between early vs. delayed initiation were compared. In a randomized, pilot study conducted in the Kilimanjaro Region of Tanzania, HIV-infected inpatients with smear-positive TB and total lymphocyte count <1200/mm(3) were randomized to initiate ABC/3TC/ZDV either 2 (early) or 8 (delayed) weeks after commencing antituberculosis therapy and were followed for 104 weeks. Of 94 patients screened, 70 enrolled (41% female, median CD4 count 103 cells/mm(3)), and 33 in each group completed 104 weeks. Two deaths and 12 serious adverse events (SAEs) were observed in the early arm vs. one death, one clinical failure, and seven SAEs in the delayed arm (p = 0.6012 for time to first grade 3/4 event, SAE, or death). CD4 cell increases were +331 and +328 cells/mm(3), respectively. TB-immune reconstitution inflammatory syndromes (TB-IRIS) were not observed in any subject. Using intent-to-treat (ITT), missing = failure analyses, 74% (26/35) vs. 89% (31/35) randomized to early vs. delayed therapy had HIV RNA levels <400 copies/ml at 104 weeks (p = 0.2182) and 66% (23/35) vs. 74% (26/35), respectively, had HIV RNA levels <50 copies/ml (p = 0.6026). In an analysis in which switches from ABC/3TC/ZDV = failure, those receiving early therapy were less likely to be suppressed to <400 copies/ml [60% (21/35) vs. 86% (30/35), p = 0.030]. TB-IRIS was not observed among the 70 coinfected subjects beginning antiretroviral treatment. ABC/3TC/ZDV was well tolerated and resulted in steady immunologic improvement. Rates of virologic suppression were similar between early and delayed treatment strategies with triple nucleoside regimens when substitutions were allowed.
dc.format.extent 1277 - 1285
dc.language eng
dc.relation.ispartof AIDS Res Hum Retroviruses
dc.relation.isversionof 10.1089/aid.2009.0100
dc.subject Adult
dc.subject Anti-HIV Agents
dc.subject CD4 Lymphocyte Count
dc.subject Dideoxynucleosides
dc.subject Drug Therapy, Combination
dc.subject Female
dc.subject HIV Infections
dc.subject HIV-1
dc.subject Humans
dc.subject Immune Reconstitution Inflammatory Syndrome
dc.subject Lamivudine
dc.subject Male
dc.subject Pilot Projects
dc.subject Tanzania
dc.subject Tuberculosis
dc.subject Viral Load
dc.subject Zidovudine
dc.title Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania.
dc.type Journal Article
duke.description.endpage 1285 en_US
duke.description.issue 12 en_US
duke.description.startpage 1277 en_US
duke.description.volume 25 en_US
dc.relation.journal AIDS Research and Human Retroviruses en_US
pubs.issue 12
pubs.organisational-group /Duke
pubs.organisational-group /Duke/Institutes and Provost's Academic Units
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/Initiatives
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/Initiatives/Duke Science & Society
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/University Institutes and Centers
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/University Institutes and Centers/Global Health Institute
pubs.organisational-group /Duke/School of Medicine
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Medicine
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Medicine/Medicine, Infectious Diseases
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Pathology
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers/Duke Cancer Institute
pubs.organisational-group /Duke/School of Nursing
pubs.organisational-group /Duke/School of Nursing/School of Nursing - Secondary Group
pubs.publication-status Published
pubs.volume 25
dc.identifier.eissn 1931-8405

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