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Titolo:
Durable HIV-1 suppression with indinavir after failing lamivudine-containing double nucleoside therapy: a randomized controlled trial
Autore:
Foudraine, NA; Jurriaans, S; Weverling, GJ; Burger, DM; Hoetelmans, RMW; Roos, MTL; Maas, J; Miedema, F; Reiss, P; Portegies, P; de Wolf, F; Lange, JMA;
Indirizzi:
Municipal Hlth Serv, Dept Publ Hlth & Environm, Amsterdam, Netherlands Municipal Hlth Serv Amsterdam Netherlands ironm, Amsterdam, Netherlands Univ Amsterdam, Acad Med Ctr, NATEC, NL-1105 AZ Amsterdam, Netherlands Univ Amsterdam Amsterdam Netherlands NL-1105 AZ Z Amsterdam, Netherlands Univ Amsterdam, Acad Med Ctr, Dept Internal Med, NL-1105 AZ Amsterdam, Netherlands Univ Amsterdam Amsterdam Netherlands NL-1105 AZ Z Amsterdam, Netherlands Univ Amsterdam, Acad Med Ctr, Dept Human Retrovirol, NL-1105 AZ Amsterdam,Netherlands Univ Amsterdam Amsterdam Netherlands NL-1105 AZ AZ Amsterdam,Netherlands Univ Nijmegen Hosp, Dept Clin Pharm, NL-6500 HB Nijmegen, Netherlands UnivNijmegen Hosp Nijmegen Netherlands NL-6500 HB Nijmegen, Netherlands Slotervaart Hosp, Dept Pharm & Pharmacol, Amsterdam, Netherlands Slotervaart Hosp Amsterdam Netherlands harmacol, Amsterdam, Netherlands CLB, Sanguin Blood Supply Fdn, Dept Clin Viroimmunol, Amsterdam, Netherlands CLB Amsterdam Netherlands Dept Clin Viroimmunol, Amsterdam, Netherlands Univ Amsterdam, Acad Med Ctr, Dept Neurol, NL-1105 AZ Amsterdam, Netherlands Univ Amsterdam Amsterdam Netherlands NL-1105 AZ Z Amsterdam, Netherlands
Titolo Testata:
ANTIVIRAL THERAPY
fascicolo: 1, volume: 6, anno: 2001,
pagine: 55 - 62
SICI:
1359-6535(200103)6:1<55:DHSWIA>2.0.ZU;2-O
Fonte:
ISI
Lingua:
ENG
Soggetto:
IMMUNODEFICIENCY-VIRUS INFECTION; PERFORMANCE LIQUID-CHROMATOGRAPHY; INCREASED POLYMERASE FIDELITY; ZIDOVUDINE PLUS LAMIVUDINE; CEREBROSPINAL-FLUID; HIV-1-INFECTED PATIENTS; REVERSE-TRANSCRIPTASE; ANTIRETROVIRAL THERAPY; MAINTENANCE THERAPY; PROTEASE INHIBITOR;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
43
Recensione:
Indirizzi per estratti:
Indirizzo: Foudraine, NA Municipal Hlth Serv, Dept Publ Hlth & Environm, Amsterdam, Netherlands Municipal Hlth Serv Amsterdam Netherlands am, Netherlands
Citazione:
N.A. Foudraine et al., "Durable HIV-1 suppression with indinavir after failing lamivudine-containing double nucleoside therapy: a randomized controlled trial", ANTIVIR TH, 6(1), 2001, pp. 55-62

Abstract

Objective: To assess the durability of the antiretroviral effect in plasmaand cerebrospinal fluid (CSF) of antiviral therapy intensification, produced by the addition of indinavir from week 12 onwards to the original regimen of zidovudine/lamivudine or stavudine/lamivudine, after 72 weeks of follow-up using an ultrasensitive HIV-1 RNA assay. To assess CSF concentrations of indinavir at week 48. Design: In a prospectively, randomized, open, single-centre study, antiretroviral-naive patients (CD4 cell count greater than or equal to 200 cells/mul and a plasma HIV-1 RNA level greater than or equal to 10000 copies/ml) were assigned to a combination of zidovudine/lamivudine or stavudine/lamivudine. Indinavir could be added to the double nucleoside analogue regimen from week 12 or thereafter in case the plasma HIV RNA level was insufficientlysuppressed (> 500 copies/ml). Results: Forty-seven patients were enrolled (23 stavudine/lamivudine and 24 zidovudine/lamivudine), of whom 33 completed a follow-up of 72 weeks. Indinavir was added in 89% (42/47) of the patients. Only one discontinuation occurred due to virological failure. At week 72, the median plasma HIV-1 RNAlevels in the zidovudine/lamivudine group had decreased from 4.80 log(10) copies/ml to < 500 copies/ml in 100% of patients and < 50 copies/ml in 86.6% of the patients. In the stavudine/lamivudine group the plasma HIV-1 RNA decreased from 4.98 log(10) copies/ml at baseline to <500 copies/ml in 100% of patients and <less than>50 copies/ml in 66.7% of the patients. On an intent-to-treat basis these figures were 54.2 and 52.2% for zidovudine/lamivudine and stavudine/lamivudine, respectively, for the 50 copies/ml assay. Themedian CD4 cell count increased from 315 cells/mul, with 150 cells/mul in the zidovudine/lamivudine arm, and from 290 cells/mul, with 310 cells/mul in the stavudine/lamivudine arm (P=0.0001). However, the percentage of CD4 cells did not differ in each group. In the zidovudine/lamivudine group 9/10 and 5/5, and in the stavudine/lamivudine group 11/11 and 6/6 had a CSF HIV-1 RNA level < 50 copies/ml at week 12 and 48, respectively. The CSF indinavir concentration ranged from 50 to 170 ng/ml. Conclusion: The long-term HIV-1 suppression observed in this study is remarkable, as adding a single antiretroviral agent to a failing regimen goes against current notions of adequate therapy.

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Documento generato il 06/04/20 alle ore 23:41:38