Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01410058
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : December 3, 2014
State University of New York at Buffalo
Biomedical Research and Training Institute
Information provided by (Responsible Party):
Tsitsi Grace Monera, University of Zimbabwe

Brief Summary:

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.

Condition or disease Intervention/treatment
HIV Dietary Supplement: Moringa oleifera

Detailed Description:

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

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effect of Moringa Oleifera (Moringa, Drumstick/Horseradish Tree) on The Pharmacokinetics of Efavirenz and Nevirapine In-vivo.
Study Start Date : January 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
Dietary Supplement: Moringa oleifera
leaf powder
Other Names:
  • moringa
  • drumstick tree
  • horseradish tree

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

Primary Outcome Measures :
  1. Area under the plasma concentration time curve (AUC) [ Time Frame: 0-12h at steady state ]

Secondary Outcome Measures :
  1. clearance (CL) [ Time Frame: 12h at steady state ]

Other Outcome Measures:
  1. Cmax [ Time Frame: T max ]
  2. Tmax [ Time Frame: Time at which C max occurs ]

Biospecimen Retention:   Samples With DNA
Whole blood, plasma, urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV Opportunistic infections clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01410058

Parirenyatwa Hospital OI Clinic
Harare, Zimbabwe
Sponsors and Collaborators
University of Zimbabwe
State University of New York at Buffalo
Biomedical Research and Training Institute
Principal Investigator: Tsitsi G Monera, BPharmHons, MPhil, MSc CT University of Zimbabwe

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tsitsi Grace Monera, Ms, University of Zimbabwe Identifier: NCT01410058     History of Changes
Other Study ID Numbers: MO 001
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Tsitsi Grace Monera, University of Zimbabwe:
antiretroviral drug interaction
herbal medicine
herbal pharmacology

Additional relevant MeSH terms:
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Anti-HIV Agents