Open-label phase II trial of amprenavir, abacavir, and fixed-dose zidovudine/lamivudine in newly and chronically HIV-1--infected patients.
A Phase II clinical trial was designed to evaluate the efficacy and tolerability of twice-daily abacavir, amprenavir, and zidovudine (ZDV)/lamivudine (3TC) in HIV-1-infected study subjects naive to protease inhibitors and 3TC. Plasma and cerebrospinal fluid (CSF) HIV-1 RNA levels and T-cell subsets were measured. In all, 27 newly diagnosed and 12 chronically HIV-1-infected study subjects are included in the analysis. Week 48 plasma HIV-1 RNA levels were <500 copies/ml in 100% of study subjects, and <50 copies/ml in 80% of chronically infected and 100% of newly infected study subjects. The mean change in CD4 was (+)150 cells/microl (newly infected, p <.001), and (+)155 cells/microl (chronically infected, p <.001). At Week 48, evidence of cellular activation persisted in both cohorts. A twice-daily regimen of amprenavir, abacavir, and ZDV/3TC affords potent viral suppression and significant increases in total CD4(+) cells in HIV-1--infected study subjects. Patient intolerance may limit the efficacy of this combination.
Kost
R G
RG
The Aaron Diamond AIDS Research Center, New York, New York 10016, USA. rkost@adarc.org
Hurley
A
A
Zhang
L
L
Vesanen
M
M
Talal
A
A
Furlan
S
S
Caldwell
P
P
Johnson
J
J
Smiley
L
L
Ho
D
D
Markowitz
M
M
D015526:AIDS Dementia Complex / Q000188:drug therapy / Q000276:immunology / Q000821:virology; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000276:immunology / Q000821:virology; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002219:Carbamates; D002908:Chronic Disease; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004064:Digestive System / Q000187:drug effects / Q000276:immunology / Q000821:virology; D004357:Drug Synergism; D005006:Ethnicity; D005260:Female; D005663:Furans; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics / Q000276:immunology / Q000502:physiology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016131:Lymphocyte Subsets / Q000187:drug effects / Q000276:immunology; D008297:Male; D011247:Pregnancy; D012367:RNA, Viral / Q000032:analysis; D012107:Research Design; D013449:Sulfonamides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016312:Treatment Refusal; D015215:Zidovudine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000099227:Abacavir
D019380:Anti-HIV Agents; D002219:Carbamates; D015224:Dideoxynucleosides; D005663:Furans; D019259:Lamivudine; D012367:RNA, Viral; D013449:Sulfonamides; D015215:Zidovudine; D000099227:Abacavir; C095108:amprenavir