Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction
Parole chiave
Astratto
Descrizione
The use of herbal supplements is widespread in Africa, particularly for the management of HIV and AIDS. In Zimbabwe, the prevalence of herbal medicine use in HIV-infected people is as high as 79% (Sebit et al., 2000). Several studies have shown that the herb Moringa oleifera is among the top 10 herbs most commonly used by HIV-positive people in Zimbabwe (Makomeya et al 2004, Monera et al 2008). Another review also cited Moringa as one of the 53 most important African medicinal plants presently traded (van den Bout-van den Beukel et al 2006). Others included Hypoxis hemerocallidea (African potato) and Sutherlandia frutescens-(Cancer bush). Moringa is rich in β-carotene, protein, vitamin C, calcium and potassium and act as a good source of natural antioxidants (Anwar et al.,2007).It is recommended by non-governmental organisations and some African governments as an immune booster and a nutritional supplement for people living with HIV and AIDS (Ncube, 2006). Most advocates and users believe that since the herb is natural, it is free from all side effects and interactions.
Concomitant use of herbs with conventional drugs may lead to herb-drug interactions in the same way that two or more co-administered drugs may interact. Herbal constituents that are substrates for the same enzymes or transporters of conventional drugs may induce or inhibit the enzymes and/or transporter activity. Pharmacokinetic endpoints such as area under the curve (AUC), time to maximum plasma concentration (tmax), peak plasma concentration (Cmax), trough concentration (Cmin), clearance (CL), volume of distribution (Vd/F) and half-life (T1/2) may be altered significantly resulting in toxicity, more severe adverse effects, sub-therapeutic drug concentrations, HIV resistance and treatment failure.The risk of interaction increases as the number of co-administered drugs increases (de Maat et al 2003). As a result, people taking herbal medicines while on antiretroviral therapy are at very high risk because of the multitude use of highly active antiretroviral drugs and treatment of opportunistic infections, and also because herbs contain a wide range of bioactive chemical constituents.
However, evidence based information of such effects is usually lacking and as such; health practitioners' ability to make relevant clinical decisions is limited. Results of a review of in vitro studies suggest a need for in vivo metabolic drug-drug interaction studies (van den Bout-van den Beukel et al 2006). Preliminary in vivo studies in animal models can serve as a basis for clinical trials, the results of which are considered the gold standard in this era of evidence-based medicine.
Primary objectives
1. To compare the steady-state pharmacokinetics of nevirapine and efavirenz in HIV-positive patients before and after supplementation with Moringa oleifera leaf powder
2. To compare the single dose pharmacokinetics of nevirapine and efavirenz in rat models before and after supplementation with Moringa oleifera leaf powder
Secondary objectives
3. To determine the bioavailability of Moringa oleifera leaf powder in humans after oral dosing using beta carotene as a bio marker.
4. To compare urine chemistries and liver function tests in HIV patients before and after supplementation with Moringa oleifera leaf powder
5. To determine the presence of any genetic variation in the participants in the genes that code for CYP3A4 and CYP2B6
Date
Ultimo verificato: | 02/28/2019 |
Primo inviato: | 08/02/2011 |
Iscrizione stimata inviata: | 08/02/2011 |
Primo pubblicato: | 08/03/2011 |
Ultimo aggiornamento inviato: | 03/28/2019 |
Ultimo aggiornamento pubblicato: | 04/01/2019 |
Data dei primi risultati presentati: | 08/22/2017 |
Data dei primi risultati QC presentati: | 03/28/2019 |
Data dei primi risultati pubblicati: | 04/01/2019 |
Data di inizio effettiva dello studio: | 12/31/2012 |
Data di completamento primaria stimata: | 08/31/2013 |
Data stimata di completamento dello studio: | 08/31/2013 |
Condizione o malattia
Intervento / trattamento
Dietary Supplement: Moringa oleifera
Drug: Efavirenz
Drug: Nevirapine
Fase
Gruppi di braccia
Braccio | Intervento / trattamento |
---|---|
Nevirapine HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder | Drug: Nevirapine Nevirapine 200mg based regimen |
Efavirenz HIV positive patients on efavirenz containing regimen, taking Moringa oleifera | Drug: Efavirenz Efavirenz 600mg based regimen |
Criteri di idoneità
Età idonea per lo studio | 18 Years Per 18 Years |
Sessi idonei allo studio | All |
Metodo di campionamento | Probability Sample |
Accetta volontari sani | sì |
Criteri | Inclusion Criteria: - HIV positive, - ≥ 4 weeks on Nevirapine or , ≥ 2 weeks on Efavirenz containing regimen, - Supplements HAART with Moringa oleifera. Exclusion Criteria: Known hepatic, intestinal or renal disease,smoking, chronic alcohol ingestion, poor venous access, chronic alcohol ingestion, pregnant, smoking, on rifampicin, ketoconazole, isoniazid, breastfeeding, anaemia,vomiting |
Risultato
Misure di esito primarie
1. AUC [Baseline (day 22), Post-moringa (day 35)]
Misure di esito secondarie
1. C12h [Baseline (Day 22); Post-moringa (Day 35)]
Altre misure di risultato
1. Cmax [Baseline (day 22), Post-moringa (day 35)]