TMC125 exerts similar initial antiviral potency as a five-drug, triple class antiretroviral regimen.
AIDS
; 17(18): 2623-7, 2003 Dec 05.
Article
en En
| MEDLINE
| ID: mdl-14685056
ABSTRACT
OBJECTIVE:
TMC125, a next generation, non-nucleoside reverse transcriptase inhibitor (NNRTI), demonstrated a remarkable decline of plasma HIV-1 RNA during a phase IIa study. We compared the initial rate of decline of plasma HIV-1 RNA achieved by TMC125 monotherapy with that of a triple class, five-drug regimen, containing drugs from all three currently licensed classes (zidovudine, lamivudine, abacavir, indinavir and nevirapine).METHODS:
The decline in plasma HIV-1 RNA of 12 HIV-1 infected, antiretroviral (ART) naive patients treated for 1 week with TMC125 monotherapy was compared with that observed in the ERA study (n = 11). The plasma HIV-1 RNA elimination rate constant was calculated based on at least four plasma HIV-1 RNA measurements during the first week of treatment (first-order elimination) and compared using the Student's t test.RESULTS:
Median ages were 23 and 38 years for TMC125 and ERA patients, respectively (P = 0.001), median baseline plasma HIV-1 RNA levels were 4.2 and 4.8 log10 copies/ml (P = 0.001) and median baseline CD4 T-cell counts were 458 x 10(6) and 360 x 10(6) cells/l (P = 0.08). The median plasma HIV-1 RNA elimination rate constant was 0.68/day in TMC125 treated patients, and 0.56/day in ERA participants (P = 0.24). The median decline in plasma HIV-1 RNA after 7 days was 1.92 and 1.76 log10 copies (P = 0.77) and the median increase of CD4 T cells was 119 x 10(6) and 60 x 10(6) cells/l, respectively (P = 0.29).CONCLUSION:
Monotherapy with TMC125 in ART-naive, HIV-1-infected individuals resulted in a similar rate of decline of plasma HIV-1 RNA during 1 week of therapy as therapy with a five-drug regimen.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Piridazinas
/
Infecciones por VIH
/
VIH-1
/
Inhibidores de la Transcriptasa Inversa
/
Fármacos Anti-VIH
/
Terapia Antirretroviral Altamente Activa
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
AIDS
Asunto de la revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Año:
2003
Tipo del documento:
Article
País de afiliación:
Países Bajos