Clinical outcome and predictive factors of failure of highly active antiretroviral therapy in antiretroviral-experienced patients in advanced stages of HIV-1 infection. NLM AIDSLINE Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

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Clinical outcome and predictive factors of failure of highly active antiretroviral therapy in antiretroviral-experienced patients in advanced stages of HIV-1 infection.

AIDS. 1998 Sep 10;12(13):1631-7. Unique Identifier : AIDSLINE MED/98435811
d'Arminio Monforte A; Testa L; Adorni F; Chiesa E; Bini T; Moscatelli GC; Abeli C; Rusconi S; Sollima S; Balotta C; Musicco M; Galli M; Moroni M; Institute of Infectious and Tropical Diseases, University of; Milan, Italy.


Abstract: OBJECTIVE: To verify the effectiveness of highly active antiretroviral therapy (HAART) and to identify any factors predictive of clinical outcome in a clinical setting. DESIGN: Observational study. METHODS: Treatment failure (i.e., the occurrence of new or recurrent AIDS-defining events, death or any definitive discontinuation) and the course of CD4+ cell counts and HIV RNA copies were evaluated in 250 heavily pretreated HIV-infected patients starting HAART [153 with indinavir (IDV), 55 with ritonavir (RTV), 43 with saquinavir (SQV)]. Univariate and multivariate analyses were performed to identify predictors of worse outcome. RESULTS: During a median follow-up of 8 months, 75 patients (30%) had treatment failure because of the occurrence of an AIDS-defining event or death (n = 24), inefficacy (n = 24), or severe intolerance (n = 27). Twenty new and six recurrent AIDS-defining events, and nine deaths occurred (six out of 20 AIDS-defining events and two out of nine deaths within 1 month of treatment). CD4+ counts were above 200 x 10(6)/l at AIDS diagnosis in only two patients. None of the SQV patients, 12 (7.8%) of the IDV patients, and 15 (27.3%) of the RTV-treated patients were considered non-compliant. The SQV-containing regimens independently correlated with treatment failure (relative risk, 2.46; 95% confidence interval, 1.20-5.03; versus IDV). Low compliance partially determined outcome in RTV-treated patients; both severe immunodepression and AIDS at baseline were predictive of treatment failure. There was a 10-fold increase in CD4+ cell counts in the patients treated with IDV and RTV; the best virological outcome occurred in IDV-treated patients, with 68.4% of patients showing undetectable HIV RNA copies after 6 months. CONCLUSIONS: HAART was effective in 70% of patients; low compliance and previous AIDS diagnosis represented predictive factors of therapy failure.
Keywords: CLINICAL TRIAL JOURNAL ARTICLE Adult Anti-HIV Agents/*THERAPEUTIC USE Cohort Studies CD4 Lymphocyte Count Drug Therapy, Combination Female Human HIV Infections/*DRUG THERAPY/IMMUNOLOGY HIV Protease Inhibitors/*THERAPEUTIC USE *HIV-1 Indinavir/*THERAPEUTIC USE Male Observation Ritonavir/*THERAPEUTIC USE RNA, Viral/BLOOD Saquinavir/*THERAPEUTIC USE Support, U.S. Gov't, P.H.S. Treatment FailureKWDclinicaltrialjournalarticleadultanti-hivagents/KWDtherapeuticusecohortstudiescd4lymphocytecountdrugtherapy,combinationfemalehumanhivinfections/KWDdrugtherapy/immunologyhivproteaseinhibitors/KWDtherapeuticuseKWDhiv-1indinavir/KWDtherapeuticusemaleobservationritonavir/KWDtherapeuticuserna,viral/bloodsaquinavir/KWDtherapeuticusesupport,uKWDsKWDgov't,pKWDhKWDsKWDtreatmentfailure
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Copyright © 1999 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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