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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania
AIDS Research and Human Retroviruses, Volume 25, No. 12, Year 2009
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Description
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/mm3 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 103cells/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 +328cells/mm3, 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 <400copies/ml at 104 weeks (p=0.2182) and 66% (23/35) vs. 74% (26/35), respectively, had HIV RNA levels <50copies/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 <400copies/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. © 2009, Mary Ann Liebert, Inc.
Authors & Co-Authors
Shao, Humphrey J.
Tanzania, Moshi
Kilimanjaro Christian Medical Centre
Tanzania, Moshi
Kilimanjaro Christian Medical University College
Crump, John A.
Tanzania, Moshi
Kilimanjaro Christian Medical Centre
Tanzania, Moshi
Kilimanjaro Christian Medical University College
United States, Durham
Duke University Medical Center
United States, Durham
Duke University
Ramadhani, Habib Omari
Tanzania, Moshi
Kilimanjaro Christian Medical Centre
Tanzania, Moshi
Kilimanjaro Christian Medical University College
Uiso, Leonard O.
Tanzania, Kilimanjaro
Kibong'oto National Tuberculosis Hospital
Ole-Nguyaine, Sendui
Tanzania, Moshi
Kilimanjaro Christian Medical Centre
Tanzania, Moshi
Kilimanjaro Christian Medical University College
Moon, Andrew M.
United States, Durham
Duke University Medical Center
Kiwera, Rehema A.
Unknown Affiliation
Woods, Christopher W.
United States, Durham
Duke University Medical Center
United States, Durham
Duke University
Shao, John F.
Tanzania, Moshi
Kilimanjaro Christian Medical Centre
Tanzania, Moshi
Kilimanjaro Christian Medical University College
Bartlett, John A.
Tanzania, Moshi
Kilimanjaro Christian Medical Centre
Tanzania, Moshi
Kilimanjaro Christian Medical University College
United States, Durham
Duke University Medical Center
United States, Durham
Duke University
Thielman, Nathan M.
United States, Durham
Duke University Medical Center
United States, Durham
Duke University
Statistics
Citations: 25
Authors: 11
Affiliations: 5
Identifiers
Doi:
10.1089/aid.2009.0100
ISSN:
08892229
Research Areas
Infectious Diseases
Study Locations
Tanzania
Participants Gender
Female