title: Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment.
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 < 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.
authors.affiliation: Burnside Clinic, Columbia, SC, USA.
authors.forename: Larry R
authors.initials: LR
authors.lastname: Kirkland
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Fischl
authors.forename: Karen T
authors.initials: KT
authors.lastname: Tashima
authors.forename: David
authors.initials: D
authors.lastname: Paar
authors.forename: Thomas
authors.initials: T
authors.lastname: Gensler
authors.forename: Neil M
authors.initials: NM
authors.lastname: Graham
authors.forename: Haitao
authors.initials: H
authors.lastname: Gao
authors.forename: Jacqueline R Carranza
authors.initials: JR
authors.lastname: Rosenzweig
authors.forename: Daniel R
authors.initials: DR
authors.lastname: McClernon
authors.forename: Ginger
authors.initials: G
authors.lastname: Pittman
authors.forename: Siegrid M
authors.initials: SM
authors.lastname: Hessenthaler
authors.forename: Jaime E
authors.initials: JE
authors.lastname: Hernandez
mesh_terms: 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
chemical_list: D015224:Dideoxynucleosides; D019259:Lamivudine; D015215:Zidovudine; D000099227:Abacavir