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Virological and immunological analysis of a triple combination pilot study with loviride, lamivudine and zidovudine in HIV-1-infected patients.
Staszewski, S; Miller, V; Rehmet, S; Stark, T; De Crée, J; De Brabander, M; Peeters, M; Andries, K; Moeremans, M; De Raeymaeker, M; Pearce, G; Van den Broeck, R; Verbiest, W; Stoffels, P.
Afiliação
  • Staszewski S; Johann Wolfgang Goethe University, Frankfurt, Germany.
AIDS ; 10(5): F1-7, 1996 May.
Article em En | MEDLINE | ID: mdl-8724034
OBJECTIVE: To compare two antiretroviral regiments, loviride plus lamivudine (3TC) plus zidovudine (ZDV) (triple combination) and loviride plus ZDV (double combination) in terms of pharmacokinetic interactions, tolerability, safety, and immunological and virological efficacy. STUDY DESIGN: An open, case-controlled, pharmacokinetic and 24-week continuous treatment pilot study. PATIENTS: Twenty p24 antigen-positive patients, 10 per treatment group, were matched according to p24 antigenaemia less or more than 100 pg, CD4 count less or more than 150 x 10-(6)/l, and gender. Eight out of 10 cases and seven out of 10 controls had received previous antiretroviral therapy. RESULTS: No clinically relevant pharmacokinetic interactions were observed. Both treatment combinations were well tolerated. Median absolute and percentage CD4 count increases above baseline were more pronounced in the triple combination arm than in the double combination arm. Median p24-antigen and plasma viraemia level decreases below baseline were more pronounced in the triple combination arm. The M(184)I/V mutation was detected in all plasma samples of triple combination patients examined at week 12. Mutations conferring resistance to loviride and ZDV were found in a significant subset of patients in both treatment arms. CONCLUSIONS: Both combination regimens have an excellent safety/tolerability profile, but a higher level of in vivo efficacy is achieved by the triple combination, despite genotypic changes conferring resistance to one or all of these agents. The conclusions drawn are limited by small population size and the heterogenous pretreatment history. However, they support the validity of and strongly encourage a rationally designed multidrug combination approach to HIV therapy.
Assuntos
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antivirais / Acetofenonas / Zidovudina / Infecções por HIV / HIV-1 / Zalcitabina / Acetamidas Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Limite: Adult / Female / Humans / Middle aged Idioma: En Revista: AIDS Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Ano de publicação: 1996 Tipo de documento: Article País de afiliação: Alemanha País de publicação: Reino Unido
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antivirais / Acetofenonas / Zidovudina / Infecções por HIV / HIV-1 / Zalcitabina / Acetamidas Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Limite: Adult / Female / Humans / Middle aged Idioma: En Revista: AIDS Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Ano de publicação: 1996 Tipo de documento: Article País de afiliação: Alemanha País de publicação: Reino Unido