Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania.

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.

Department

Description

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Citation

Published Version (Please cite this version)

10.1089/aid.2009.0100

Publication Info

Shao, Humphrey J, John A Crump, Habib O Ramadhani, Leonard O Uiso, Sendui Ole-Nguyaine, Andrew M Moon, Rehema A Kiwera, Christopher W Woods, et al. (2009). Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania. AIDS Res Hum Retroviruses, 25(12). pp. 1277–1285. 10.1089/aid.2009.0100 Retrieved from https://hdl.handle.net/10161/5969.

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Scholars@Duke

Woods

Christopher Wildrick Woods

Wolfgang Joklik Distinguished Professor of Global Health

1. Emerging Infections
2. Global Health
3. Epidemiology of infectious diseases
4. Clinical microbiology and diagnostics
5. Bioterrorism Preparedness
6. Surveillance for communicable diseases
7. Antimicrobial resistance

Bartlett

John Alexander Bartlett

Professor of Medicine

My clinical investigation is focused on the pathogenesis and treatment of HIV infection and its complications, especially in resource-limited settings.

Key Words: HIV infection, AIDS, treatment strategies, treatment failure, co-infections, resource-limited settings

Thielman

Nathan Maclyn Thielman

Professor of Medicine

Broadly, my research focuses on a range of clinical and social issues that affect persons living with or at risk for HIV infection in resource-poor settings. In Tanzania, our group is applying novel methods to optimize HIV testing uptake among high-risk groups. We recently demonstrated that the Discrete Choice Experiment (DCE), a form of stated preference survey research, is a robust tool for identifying (a) which characteristics of HIV testing options are most preferred by different populations and (b) which tradeoffs individuals make in evaluating testing options. Building on more than a decade of productive HIV testing research in the Kilimanjaro Region, the next phase of our NIMH funded project will test the hypothesis that DCE-derived HIV testing options significantly increases rates of testing among groups at high risk for HIV infection. This work holds promise not only for optimizing HIV testing uptake in the Kilimanjaro Region, but also for applying novel tools in the service of translational epidemiology and implementation research.


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