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.
Type
Journal articleSubject
AdultAnti-HIV Agents
CD4 Lymphocyte Count
Dideoxynucleosides
Drug Therapy, Combination
Female
HIV Infections
HIV-1
Humans
Immune Reconstitution Inflammatory Syndrome
Lamivudine
Male
Pilot Projects
Tanzania
Tuberculosis
Viral Load
Zidovudine
Permalink
https://hdl.handle.net/10161/5969Published Version (Please cite this version)
10.1089/aid.2009.0100Publication Info
Shao, Humphrey J; Crump, John A; Ramadhani, Habib O; Uiso, Leonard O; Ole-Nguyaine,
Sendui; Moon, Andrew M; ... Thielman, Nathan M (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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
John Alexander Bartlett
Professor of Medicine
My clinical investigation is focused on the pathogenesis and treatment of HIV infection
and its complicastions, especially in resource-limited settings. Key Words: HIV infection,
AIDS, treatment strategies, treatment failure, co-infections, resource-limited settings
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 populati
Christopher Wildrick Woods
Professor of Medicine
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
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