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1.
AIDS ; 21(8): 947-55, 2007 May 11.
Article in English | MEDLINE | ID: mdl-17457088

ABSTRACT

OBJECTIVE: To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial. DESIGN: PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART). METHODS: 128 ART-naïve children were randomised to zidovudine\lamivudine (n = 36), zidovudine\abacavir (45) or lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo. RESULTS: Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\lamivudine, zidovudine\abacavir and lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\lamivudine, 50%/25% zidovudine\abacavir and 79%/63% lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); lamivudine\abacavir (K65R, L74V, Y115F, M184V). CONCLUSIONS: Five year data demonstrate that lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.


Subject(s)
Dideoxynucleosides/therapeutic use , HIV Infections/drug therapy , HIV-1 , Lamivudine/therapeutic use , Reverse Transcriptase Inhibitors/therapeutic use , Adolescent , Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly Active/methods , CD4 Lymphocyte Count , Child , Child, Preschool , Drug Resistance, Viral , Follow-Up Studies , Growth/drug effects , HIV Infections/immunology , HIV Infections/physiopathology , HIV Infections/virology , HIV-1/isolation & purification , Humans , Infant , RNA, Viral/blood , Treatment Outcome , Viral Load , Zidovudine/therapeutic use
2.
J Ethnopharmacol ; 58(1): 21-30, 1997 Sep.
Article in English | MEDLINE | ID: mdl-9324001

ABSTRACT

The present study reports on the effects of horminone on serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, on hepatic cytochrome P450 (P450) and cytochrome b5 (cyt b5) contents and on the activities of NADPH-cytochrome P450 reductase (NR), mixed function mono-oxygenases (MFO), glutathione-S-transferase (GST) and glutathione reductase (GR) of Wistar male rat. Horminone is a diterpenoid quinone (7,12-dihydroxyabiet-8,12-diene-11,14-dione) present in several species of the Labiatae family and used as medicinal plants in folk medicine. In this study, horminone was administered by the intraperitoneal route (i.p.) at a concentration of 1 or 10 mg/kg to each group of six mice, using water as a vehicle. On the one hand, results showed that horminone increased serum ALT and AST levels and cyt b5 content and induced the activities of ethylmorphine N-demethylase (EMD). On the other hand, horminone decreased P450 content and inhibited the activities of 7-ethoxyresorufin O-deethylase (ERD), 7-ethoxycoumarin O-deethylase (ECD), aniline 4-hydroxylase (AH) and NR. Based on these results, the possibility of toxic effects occurring after administration of plant extracts containing horminone must be considered.


Subject(s)
Abietanes , Diterpenes/pharmacology , Glutathione Reductase/blood , Glutathione Transferase/blood , Liver/enzymology , Mixed Function Oxygenases/blood , 7-Alkoxycoumarin O-Dealkylase/metabolism , Alanine Transaminase/blood , Aniline Hydroxylase/metabolism , Animals , Aspartate Aminotransferases/blood , Cytochrome P-450 CYP1A1/metabolism , Cytochrome P-450 Enzyme System/blood , Cytochromes b5/blood , Diterpenes/administration & dosage , Enzyme Induction/drug effects , Ethylmorphine-N-Demethylase/biosynthesis , Injections, Intraperitoneal , Liver/drug effects , Liver Function Tests , Male , Mice , NADPH-Ferrihemoprotein Reductase/blood , Plants, Medicinal , Rats , Rats, Wistar
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