Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine

Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine

Autor Haas, D. W. Google Scholar
Arathoon, E. Google Scholar
Thompson, M. A. Google Scholar
Pedro, R. D. Google Scholar
Gallant, J. E. Google Scholar
Uip, D. E. Google Scholar
Currier, J. Google Scholar
Noriega, L. M. Google Scholar
Lewi, David S. Autor UNIFESP Google Scholar
Uribe, P. Google Scholar
Benetucci, J. Google Scholar
Cahn, P. Google Scholar
Paar, D. Google Scholar
White, C. A. Google Scholar
Collier, A. C. Google Scholar
Ramirez-Ronda, C. H. Google Scholar
Harvey, C. Google Scholar
Chung, M. Google Scholar
Mehrotra, D. Google Scholar
Chodakewitz, J. Google Scholar
Nguyen, B. Y. Google Scholar
Protocol 054 069 Study Teams Google Scholar
Instituição Vanderbilt Univ
Guatemalan Assoc Prevent & Control AIDS
AIDS Res Consortium Atlanta
Universidade Estadual de Campinas (UNICAMP)
Johns Hopkins Univ
Universidade de São Paulo (USP)
Univ So Calif
Hosp Dr Sotero del Rio
Universidade Federal de São Paulo (UNIFESP)
CONASIDA
Hosp Muniz
Huesped Fdn
Univ Texas
Baylor Coll Med
Univ Washington
Vet Adm Med Ctr
Merck Res Labs
Resumo Objectives: To compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. Design: Two multicenter, open-label, randomized 24-week studies.Methods: Adults HIV-1 infection, HIV-1 RNA greater than 10 000 copies/ml, and no prior lamivudine or protease inhibitor therapy were eligible. in a pilot study (Study A), patients received indinavir at 800 mg every 8 h, 1000 mg every 12 h, or 1200 mg every 12 h. in a subsequent study (Study B), patients received indinavir at 800 mg every 8 h or 1200 mg every 12 h. All subjects received zidovudine (300 mg) and lamivudine (150 mg) every 12 h. An intent-to-treat analysis was used.Results: in Study A, which enrolled 88 patients, neither HIV-1 RNA nor CD4, cell responses differed significantly between treatment groups at 24 weeks when corrected for multiple comparisons. Study B enrolled 433 patients, but was prematurely discontinued when interim analysis suggested greater efficacy of three-times-daily indinavir. of the first 87 patients reaching week 24, HIV-1 RNA was less than 400 copies/ml in 91% receiving three-times-daily versus 64% receiving two-times daily indinavir (P < 0.01).Conclusion: Three-limes-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine. Two-times-daily indinavir dosing should only be considered in situations characterized by favorable pharmacokinetic drug-drug interactions. (C) 2000 Lippincott Williams & Wilkins.
Assunto antiretroviral therapy
indinavir
clinical trial
zidovudine
lamivudine
HIV infection
viral load
HIV protease inhibitors
Idioma Inglês
Data 2000-09-08
Publicado em Aids. Philadelphia: Lippincott Williams & Wilkins, v. 14, n. 13, p. 1973-1978, 2000.
ISSN 0269-9370 (Sherpa/Romeo, fator de impacto)
Editor Lippincott Williams & Wilkins
Extensão 1973-1978
Fonte http://dx.doi.org/10.1097/00002030-200009080-00013
Direito de acesso Acesso aberto Open Access
Tipo Artigo
Web of Science WOS:000089180700013
URI http://repositorio.unifesp.br/handle/11600/26382

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