title: Impact of an educational program on efficacy and adherence with a twice-daily lamivudine/zidovudine/abacavir regimen in underrepresented HIV-infected patients.
abstract: A 24-week open-label clinical trial was conducted in 195 HIV-infected adults commonly underrepresented in research (35% female, 71% African American, 21% Hispanic, and 20% injection drug users [IDUs]) to evaluate the effect of an HIV educational program on efficacy and adherence with a simple, compact, twice-daily triple nucleoside regimen containing a lamivudine (150 mg)/zidovudine (300 mg) combination (COM) tablet plus abacavir (ABC), 300 mg. At baseline, the patients' median plasma HIV-1 RNA level was 4.18 log10 copies/mL and the median CD4+ cell count was 379 cells/mm3. Patients were randomized 1:1 to 4 modules of the Tools for Health and Empowerment HIV education intervention plus routine counseling (EI + RC; n = 96) or to routine counseling alone (RC; n = 99). No differences between the EI + RC and RC treatment arms were observed with respect to the proportion of patients achieving plasma HIV-1 RNA levels <40 copies/mL (60% [33/55] vs. 55% [38/69]; P = 0.529) or <400 copies/mL (80% [44/55] vs. 80% [55/69]; P = 0.689) at week 24 (intent-to-treat observed analysis), increase in median CD4 cell count above baseline at week 24 (78.3 vs. 104.8 cells/mm3; P = 0.498), or mean overall adherence rates as measured by the Medication Event Monitoring System (MEMS) (70% vs. 74%). COM + ABC was generally well tolerated, and no association was observed between interruptions in treatment and the development of ABC hypersensitivity (5 suspected cases). In conclusion, in underrepresented patients, the EI used in this study did not affect the efficacy and adherence results with ABC + COM to any greater degree than did RC.
authors.affiliation: Southeast Dallas Health Center, Texas, USA. mkrawlings@imanihiv.org
authors.forename: M Keith
authors.initials: MK
authors.lastname: Rawlings
authors.forename: Melanie A
authors.initials: MA
authors.lastname: Thompson
authors.forename: Charles F
authors.initials: CF
authors.lastname: Farthing
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Brown
authors.forename: Joseph
authors.initials: J
authors.lastname: Racine
authors.forename: Robert C
authors.initials: RC
authors.lastname: Scott
authors.forename: Karen H
authors.initials: KH
authors.lastname: Crawford
authors.forename: S Diane
authors.initials: SD
authors.lastname: Goodwin
authors.forename: Jerry M
authors.initials: JM
authors.lastname: Tolson
authors.forename: Vanessa C
authors.initials: VC
authors.lastname: Williams
authors.forename: Mark S
authors.initials: MS
authors.lastname: Shaefer
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active; D015224:Dideoxynucleosides / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010353:Patient Education as Topic; D012367:RNA, Viral / Q000097:blood; D015215:Zidovudine / Q000008:administration & dosage / Q000009:adverse effects; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D019259:Lamivudine; D012367:RNA, Viral; D015215:Zidovudine; D000099227:Abacavir