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

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dc.contributor.authorHaas, D. W.
dc.contributor.authorArathoon, E.
dc.contributor.authorThompson, M. A.
dc.contributor.authorPedro, R. D.
dc.contributor.authorGallant, J. E.
dc.contributor.authorUip, D. E.
dc.contributor.authorCurrier, J.
dc.contributor.authorNoriega, L. M.
dc.contributor.authorLewi, David S. [UNIFESP]
dc.contributor.authorUribe, P.
dc.contributor.authorBenetucci, J.
dc.contributor.authorCahn, P.
dc.contributor.authorPaar, D.
dc.contributor.authorWhite, C. A.
dc.contributor.authorCollier, A. C.
dc.contributor.authorRamirez-Ronda, C. H.
dc.contributor.authorHarvey, C.
dc.contributor.authorChung, M.
dc.contributor.authorMehrotra, D.
dc.contributor.authorChodakewitz, J.
dc.contributor.authorNguyen, B. Y.
dc.contributor.authorProtocol 054 069 Study Teams
dc.contributor.institutionVanderbilt Univ
dc.contributor.institutionGuatemalan Assoc Prevent & Control AIDS
dc.contributor.institutionAIDS Res Consortium Atlanta
dc.contributor.institutionUniversidade Estadual de Campinas (UNICAMP)
dc.contributor.institutionJohns Hopkins Univ
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionUniv So Calif
dc.contributor.institutionHosp Dr Sotero del Rio
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionCONASIDA
dc.contributor.institutionHosp Muniz
dc.contributor.institutionHuesped Fdn
dc.contributor.institutionUniv Texas
dc.contributor.institutionBaylor Coll Med
dc.contributor.institutionUniv Washington
dc.contributor.institutionVet Adm Med Ctr
dc.contributor.institutionMerck Res Labs
dc.date.accessioned2016-01-24T12:31:10Z
dc.date.available2016-01-24T12:31:10Z
dc.date.issued2000-09-08
dc.description.abstractObjectives: 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.en
dc.description.affiliationVanderbilt Univ, Sch Med, Div Infect Dis, Nashville, TN 37212 USA
dc.description.affiliationGuatemalan Assoc Prevent & Control AIDS, Clin Familiar Luis Angel Garcia, Guatemala City, Guatemala
dc.description.affiliationAIDS Res Consortium Atlanta, Atlanta, GA USA
dc.description.affiliationUniv Estadual Campinas, Fac Ciencias Med, São Paulo, Brazil
dc.description.affiliationJohns Hopkins Univ, Baltimore, MD USA
dc.description.affiliationUniv São Paulo, São Paulo, Brazil
dc.description.affiliationUniv So Calif, Los Angeles, CA USA
dc.description.affiliationHosp Dr Sotero del Rio, Santiago, Chile
dc.description.affiliationUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliationCONASIDA, Mexico City, DF, Mexico
dc.description.affiliationHosp Muniz, Buenos Aires, DF, Argentina
dc.description.affiliationHuesped Fdn, Buenos Aires, DF, Argentina
dc.description.affiliationUniv Texas, Galveston, TX 77555 USA
dc.description.affiliationBaylor Coll Med, Houston, TX 77030 USA
dc.description.affiliationUniv Washington, Sch Med, Seattle, WA USA
dc.description.affiliationVet Adm Med Ctr, San Juan, PR USA
dc.description.affiliationMerck Res Labs, West Point, PA USA
dc.description.affiliationUnifespUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.format.extent1973-1978
dc.identifierhttp://dx.doi.org/10.1097/00002030-200009080-00013
dc.identifier.citationAids. Philadelphia: Lippincott Williams & Wilkins, v. 14, n. 13, p. 1973-1978, 2000.
dc.identifier.doi10.1097/00002030-200009080-00013
dc.identifier.issn0269-9370
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/26382
dc.identifier.wosWOS:000089180700013
dc.language.isoeng
dc.publisherLippincott Williams & Wilkins
dc.relation.ispartofAids
dc.rightsAcesso aberto
dc.subjectantiretroviral therapyen
dc.subjectindinaviren
dc.subjectclinical trialen
dc.subjectzidovudineen
dc.subjectlamivudineen
dc.subjectHIV infectionen
dc.subjectviral loaden
dc.subjectHIV protease inhibitorsen
dc.titleComparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudineen
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