Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment.
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 < or =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 log(10) copies/mL for the HIV-1 RNA level and +111 cells/mm(3) 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.
Kirkland
Larry R
LR
Burnside Clinic, Columbia, SC, USA.
Fischl
Margaret A
MA
Tashima
Karen T
KT
Paar
David
D
Gensler
Thomas
T
Graham
Neil M
NM
Gao
Haitao
H
Rosenzweig
Jacqueline R Carranza
JR
McClernon
Daniel R
DR
Pittman
Ginger
G
Hessenthaler
Siegrid M
SM
Hernandez
Jaime E
JE
D000293:Adolescent; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000191:economics; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D015215:Zidovudine / Q000009:adverse effects / Q000627:therapeutic use*; D000099227:Abacavir
D015224:Dideoxynucleosides; D019259:Lamivudine; D015215:Zidovudine; D000099227:Abacavir