Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction

This study is currently recruiting participants.
Verified August 2013 by University of Zimbabwe
Sponsor:
Collaborators:
State University of New York at Buffalo
Biomedical Research and Training Institute
Information provided by (Responsible Party):
Tsitsi Grace Monera, University of Zimbabwe
ClinicalTrials.gov Identifier:
NCT01410058
First received: August 3, 2011
Last updated: August 8, 2013
Last verified: August 2013

August 3, 2011
August 8, 2013
January 2013
October 2013   (final data collection date for primary outcome measure)
Area under the plasma concentration time curve (AUC) [ Time Frame: 0-12h at steady state ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01410058 on ClinicalTrials.gov Archive Site
clearance (CL) [ Time Frame: 12h at steady state ] [ Designated as safety issue: Yes ]
Same as current
  • Cmax [ Designated as safety issue: Yes ]
  • Tmax [ Designated as safety issue: Yes ]
Not Provided
 
Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction
Effect of Moringa Oleifera (Moringa, Drumstick/Horseradish Tree) on The Pharmacokinetics of Efavirenz and Nevirapine In-vivo.

A study will be conducted by scientists from the University of Zimbabwe to determine if antiretroviral drugs are affected by taking herbs at the same time. This is important because herbal medicines may interact with modern medicine to increase or decrease the amount of medication in the body.

The drugs nevirapine and efavirenz will be studied. Both drugs are routinely used as part of combination therapy for treating HIV. In this study it will be determined whether the concentrations of the antiretroviral drugs nevirapine and efavirenz are low, high or are in the desired range when taken together with the herb moringa.

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
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, urine

Probability Sample

HIV Opportunistic infections clinic

HIV
Dietary Supplement: Moringa oleifera
leaf powder
Other Names:
  • moringa
  • drumstick tree
  • horseradish tree
  • Nevirapine
    HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
    Intervention: Dietary Supplement: Moringa oleifera
  • Efavirenz
    HIV positive patients on efavirenz containing regimen, taking Moringa oleifera
    Intervention: Dietary Supplement: Moringa oleifera

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
October 2013
October 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Tsitsi G Monera, BPharmHons, MPhil, PG Dip +263772432457 moneratg@yahoo.co.uk
Contact: Charles F Nhachi, BSc, MSc, MScPhD +263772318852 cnhachi@gmail.com
Zimbabwe
 
NCT01410058
MO 001
Yes
Tsitsi Grace Monera, University of Zimbabwe
University of Zimbabwe
  • State University of New York at Buffalo
  • Biomedical Research and Training Institute
Principal Investigator: Tsitsi G Monera, BPharmHons, MPhil, PG Dip. University of Zimbabwe
University of Zimbabwe
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP