title: Effect ofMoringa oleiferaLam. leaf powder on the pharmacokinetics of nevirapine in HIV-infected adults: a one sequence cross-over study.
abstract: Moringa oleiferaLam., an herb commonly consumed by HIV-infected people on antiretroviral therapy, inhibits cytochrome P450 3A4, 1A2 and 2D6 activity in vitro; and may alter the pharmacokinetics (PK) of antiretroviral drugs metabolized via the same pathways. However, in vitro drug interaction activity may not translate to a clinically significant effect. Therefore, the effect of moringa leaf powder on the PK of nevirapine in HIV-infected people was investigated.
  
  
  
  Adult patients at steady-state dosing with nevirapine were admitted for 12-h intensive PK sampling following a 21-day herbal medicine washout. Blood sampling was repeated after 14 days of nevirapine and moringa (1.85 g leaf powder/day) co-administration. Nevirapine plasma concentrations were determined by liquid chromatography-tandem mass spectrometry. To assess the effect of moringa on nevirapine PK, the change in nevirapine area under the plasma concentration-time curve (AUC) was determined. The mean difference in pre- and post-moringa nevirapine, maximum concentration (Cmax) and concentration at 12 h (C12h) were also calculated. The PK parameters were compared by assessing the post/pre geometric mean ratios (GMRs) and associated 90% confidence intervals (CIs).
  
  
  
  Pharmacokinetics analyses were performed on the results from 11 participants for whom complete data were obtained. The post/pre GMRs and associated 90% CIs for nevirapine were 1.07 (1.00-1.14) for the AUC; 1.06 (0.98-1.16) for Cmaxand 1.03 (0.92-1.16) for C12h.
  
  
  
  Co-administration ofMoringa oleiferaLam. leaf powder at the traditional dose did not significantly alter the steady-state PK of nevirapine.Trial registration numberNCT01410058 (ClinicalTrials.gov).
authors.affiliation: 0000 0004 0572 0760grid.13001.33Drug and Toxicology Information Services (DaTIS), School of Pharmacy, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
authors.forename: Tsitsi G
authors.initials: TG
authors.lastname: Monera-Penduka
authors.affiliation: 0000 0004 0572 0760grid.13001.33Drug and Toxicology Information Services (DaTIS), School of Pharmacy, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe ; 0000 0004 1936 9887grid.273335.3Center for Integrated Global Biomedical Sciences, University at Buffalo, Buffalo, NY USA.
authors.forename: Charles C
authors.initials: CC
authors.lastname: Maponga
authors.affiliation: 0000 0001 2297 6811grid.266102.1Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA USA.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Wolfe
authors.affiliation: 0000 0004 1937 1151grid.7836.aDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Lubbe
authors.initials: L
authors.lastname: Wiesner
authors.affiliation: 0000 0004 1936 9887grid.273335.3Center for Integrated Global Biomedical Sciences, University at Buffalo, Buffalo, NY USA.
authors.forename: Gene D
authors.initials: GD
authors.lastname: Morse
authors.affiliation: 0000 0004 0572 0760grid.13001.33Department of Clinical Pharmacology, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
authors.forename: Charles F B
authors.initials: CF
authors.lastname: Nhachi
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002853:Chromatography, Liquid; D018592:Cross-Over Studies; D004347:Drug Interactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D013058:Mass Spectrometry; D008875:Middle Aged; D029588:Moringa oleifera / Q000737:chemistry*; D019829:Nevirapine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018515:Plant Leaves / Q000737:chemistry*; D010949:Plasma / Q000737:chemistry; D011208:Powders / Q000008:administration & dosage* / Q000302:isolation & purification; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D011208:Powders; D019829:Nevirapine
keywords: HIV; Moringa oleifera; Nevirapine; Pharmacokinetics