TY - JOUR
T1 - Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment
AU - Kirkland, Larry R.
AU - Fischl, Margaret A.
AU - Tashima, Karen T.
AU - Paar, David
AU - Gensler, Thomas
AU - Graham, Neil M.
AU - Gao, Haitao
AU - Carranza Rosenzweig, Jacqueline R.
AU - McClernon, Daniel R.
AU - Pittman, Ginger
AU - Hessenthaler, Siegrid M.
AU - Hernandez, Jaime E.
N1 - Funding Information:
Financial support: Glaxo Wellcome Inc.
PY - 2002/2/15
Y1 - 2002/2/15
N2 - Prison inmates with human immunodeficiency virus (HIV) infection can be difficult to treat because of the complexity and intrusiveness of many combination antiretroviral therapy regimens. NZTA4007, a 24-week open-label, single-arm clinical trial involving 108 antiretroviral therapy-naive, incarcerated, HIV-infected persons, was conducted to evaluate a compact regimen (4 tablets per day) consisting of 1 lamivudine-zidovudine (150 mg/300 mg) combination tablet (COM) and one 300-mg abacavir tablet administered twice daily under directly observed treatment conditions. In the intent-to-treat observed analysis, the plasma HIV type 1 (HIV-1) RNA level remained at ≤400 copies/mL in 85% of the patients and at <50 copies/mL in 75% of the patients. Median change from baseline was -2.41 log10 copies/mL for the HIV-1 RNA level and +111 cells/mm3 for the CD4 cell count. The overall adherence to prescribed doses was 94% for patients who remained enrolled in the study. COM-abacavir given twice daily was generally well tolerated, and adverse events prompted only 4 patients to withdraw from the study.
AB - Prison inmates with human immunodeficiency virus (HIV) infection can be difficult to treat because of the complexity and intrusiveness of many combination antiretroviral therapy regimens. NZTA4007, a 24-week open-label, single-arm clinical trial involving 108 antiretroviral therapy-naive, incarcerated, HIV-infected persons, was conducted to evaluate a compact regimen (4 tablets per day) consisting of 1 lamivudine-zidovudine (150 mg/300 mg) combination tablet (COM) and one 300-mg abacavir tablet administered twice daily under directly observed treatment conditions. In the intent-to-treat observed analysis, the plasma HIV type 1 (HIV-1) RNA level remained at ≤400 copies/mL in 85% of the patients and at <50 copies/mL in 75% of the patients. Median change from baseline was -2.41 log10 copies/mL for the HIV-1 RNA level and +111 cells/mm3 for the CD4 cell count. The overall adherence to prescribed doses was 94% for patients who remained enrolled in the study. COM-abacavir given twice daily was generally well tolerated, and adverse events prompted only 4 patients to withdraw from the study.
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U2 - 10.1086/338400
DO - 10.1086/338400
M3 - Article
C2 - 11797179
AN - SCOPUS:0037083022
VL - 34
SP - 511
EP - 518
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 4
ER -