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Titolo:
A RANDOMIZED DOUBLE-BLIND TRIAL OF THE ADDITION OF LAMIVUDINE OR MATCHING PLACEBO TO CURRENT NUCLEOSIDE ANALOG REVERSE-TRANSCRIPTASE INHIBITOR THERAPY IN HIV-INFECTED CHILDREN - THE PENTA-4 TRIAL
Autore:
ABOULKER JP; BABIKER A; CARRIERE I; DARBYSHIRE JH; DEBRE M; GIAQUINTO C; GIBB DM; HARPER L; NEWBERRY A; SAIDI Y; TUDORWILLIAMS G;
Indirizzi:
MRC,HIV CLIN TRIALS CTR,MORTIMER MARKET,CAPPER ST LONDON WC1E 6AU ENGLAND MRC,HIV CLIN TRIALS CTR LONDON WC1E 6AU ENGLAND INSERM,SC10 PARIS FRANCE HOP NECKER ENFANTS MALAD PARIS FRANCE UNIV PADUA I-35100 PADUA ITALY ST MARYS HOSP LONDON ENGLAND GREAT ORMOND ST HOSP CHILDREN NHS TRUST LONDON WC1N 3JH ENGLAND
Titolo Testata:
AIDS
fascicolo: 14, volume: 12, anno: 1998,
pagine: 151 - 160
SICI:
0269-9370(1998)12:14<151:ARDTOT>2.0.ZU;2-1
Fonte:
ISI
Lingua:
ENG
Soggetto:
ZIDOVUDINE;
Keywords:
HIV-1 INFECTION; ANTIRETROVIRAL THERAPY; LAMIVUDINE; PEDIATRICS; RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
18
Recensione:
Indirizzi per estratti:
Citazione:
J.P. Aboulker et al., "A RANDOMIZED DOUBLE-BLIND TRIAL OF THE ADDITION OF LAMIVUDINE OR MATCHING PLACEBO TO CURRENT NUCLEOSIDE ANALOG REVERSE-TRANSCRIPTASE INHIBITOR THERAPY IN HIV-INFECTED CHILDREN - THE PENTA-4 TRIAL", AIDS, 12(14), 1998, pp. 151-160

Abstract

Objectives: To evaluate the toxicity, tolerability and effect on laboratory markers of adding lamivudine (3TC) to nucleoside analogue reverse transcriptase inhibitors (NRTI) in children with HIV-1 infection. Design: Randomized double-blind trial. Methods: HIV-l-infected childrenon stable NRTI therapy were randomized to receive 3TC syrup or tablets (4 mg/kg twice daily) or matching placebo in addition to existing therapy. Endpoints were serious adverse events, and changes in CD4 cell count and plasma HIV-1 RNA. Analyses were on an intention-to-treat basis. Results: A total of 162 (81 on 3TC, 81 on placebo) children [median age, 6.5 years; interquartile range (IQR), 4.1-10.1 years] were included. At randomization, 52 were receiving zidovudine (ZDV), 39 didanosine (ddl), 54 ZDV-ddl and 17 ZDV-zalcitabine (ddC); 32 (20%) had AIDS;median CD4 cell count was 328 x 10(6)/l (IQR, 127-696 x 10(6)/l), andmedian HIV-1 RNA was 4.9 log(10) copies/ml (IQR, 4.3-5.4 log(10) copies/ml). Median follow-up was 40 weeks (IQR, 29-49 weeks) and 76% of follow-up was on blinded therapy for both 3TC and placebo groups. There were 11 serious adverse events in the blinded phase [two clinical (both placebo) and nine laboratory (five 3TC, four placebo)], five (two 3TC,three placebo) resulting in stopping trial drug. At 24 weeks, the CD4 cell count was greater in the 3TC group by a median of 47 x 10(6)/l and HIV-1 RNA was lower by 0.30 log(10) copies/ml (P = 0.03 and 0.002,respectively, versus the placebo group). The difference in reduction in HIV-1 RNA up to 24 weeks, as measured by area under the curve minusbaseline, between 3TC and placebo groups was 0.38 log(10) copies/ml (95% confidence interval, 0.12-0.65) greater in children taking ZDV-containing regimens at baseline, compared with those on ddl monotherapy (P = 0.005), after adjusting for other factors at baseline. Thirteen children developed new AIDS events (six on 3TC, four on placebo) of whomthree died (all placebo). Conclusions: The addition of 3TC to currentNRTI therapy in children was safe and well-tolerated. There was evidence that treatment changes in HIV-1 RNA viral load were greater in children taking regimens that included ZDV. (C) 1998 Lippincott Williams & Wilkins.

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Documento generato il 25/09/20 alle ore 05:59:04