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

Publication ,  Journal Article
Shao, HJ; Crump, JA; Ramadhani, HO; Uiso, LO; Ole-Nguyaine, S; Moon, AM; Kiwera, RA; Woods, CW; Shao, JF; Bartlett, JA; Thielman, NM
Published in: AIDS Res Hum Retroviruses
December 2009

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.

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Published In

AIDS Res Hum Retroviruses

DOI

EISSN

1931-8405

Publication Date

December 2009

Volume

25

Issue

12

Start / End Page

1277 / 1285

Location

United States

Related Subject Headings

  • Zidovudine
  • Virology
  • Viral Load
  • Tuberculosis
  • Tanzania
  • Pilot Projects
  • Male
  • Lamivudine
  • Immune Reconstitution Inflammatory Syndrome
  • Humans
 

Citation

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Shao, H. J., Crump, J. A., Ramadhani, H. O., Uiso, L. O., Ole-Nguyaine, S., Moon, A. M., … Thielman, N. 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), 1277–1285. https://doi.org/10.1089/aid.2009.0100
Shao, Humphrey J., John A. Crump, Habib O. Ramadhani, Leonard O. Uiso, Sendui Ole-Nguyaine, Andrew M. Moon, Rehema A. Kiwera, et al. “Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania.AIDS Res Hum Retroviruses 25, no. 12 (December 2009): 1277–85. https://doi.org/10.1089/aid.2009.0100.
Shao HJ, Crump JA, Ramadhani HO, Uiso LO, Ole-Nguyaine S, Moon AM, et al. Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania. AIDS Res Hum Retroviruses. 2009 Dec;25(12):1277–85.
Shao, Humphrey J., et al. “Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania.AIDS Res Hum Retroviruses, vol. 25, no. 12, Dec. 2009, pp. 1277–85. Pubmed, doi:10.1089/aid.2009.0100.
Shao HJ, Crump JA, Ramadhani HO, Uiso LO, Ole-Nguyaine S, Moon AM, Kiwera RA, Woods CW, Shao JF, Bartlett JA, Thielman NM. Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania. AIDS Res Hum Retroviruses. 2009 Dec;25(12):1277–1285.
Journal cover image

Published In

AIDS Res Hum Retroviruses

DOI

EISSN

1931-8405

Publication Date

December 2009

Volume

25

Issue

12

Start / End Page

1277 / 1285

Location

United States

Related Subject Headings

  • Zidovudine
  • Virology
  • Viral Load
  • Tuberculosis
  • Tanzania
  • Pilot Projects
  • Male
  • Lamivudine
  • Immune Reconstitution Inflammatory Syndrome
  • Humans