Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 511-518 |
| Number of pages | 8 |
| Journal | Clinical Infectious Diseases |
| Volume | 34 |
| Issue number | 4 |
| DOIs | |
| State | Published - Feb 15 2002 |
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ASJC Scopus subject areas
- Immunology
Cite this
Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment. / Kirkland, Larry R.; Fischl, Margaret A; Tashima, Karen T.; Paar, David; Gensler, Thomas; Graham, Neil M.; Gao, Haitao; Carranza Rosenzweig, Jacqueline R.; McClernon, Daniel R.; Pittman, Ginger; Hessenthaler, Siegrid M.; Hernandez, Jaime E.
In: Clinical Infectious Diseases, Vol. 34, No. 4, 15.02.2002, p. 511-518.Research output: Contribution to journal › Article
}
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.
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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UR - http://www.scopus.com/inward/citedby.url?scp=0037083022&partnerID=8YFLogxK
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 -