Trial record 18 of 34 for:    " July 27, 2011":" August 26, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
HIV
Dietary Supplement: Moringa oleifera
Phase 1
Phase 2

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Zimbabwe:

Primary Outcome Measures:
  • Area under the plasma concentration time curve (AUC) [ Time Frame: 0-12h at steady state ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clearance (CL) [ Time Frame: 12h at steady state ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Cmax [ Designated as safety issue: Yes ]
  • Tmax [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Whole blood, urine


Estimated Enrollment: 28
Study Start Date: January 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nevirapine
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
Efavirenz
HIV positive patients on efavirenz containing regimen, taking Moringa oleifera
Dietary Supplement: Moringa oleifera
leaf powder
Other Names:
  • moringa
  • drumstick tree
  • horseradish tree

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV Opportunistic infections clinic

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410058

Contacts
Contact: Tsitsi G Monera, BPharmHons, MPhil, PG Dip +263772432457 moneratg@yahoo.co.uk
Contact: Charles F Nhachi, BSc, MSc, MScPhD +263772318852 cnhachi@gmail.com

Locations
Zimbabwe
Parirenyatwa Hospital OI Clinic Recruiting
Harare, Zimbabwe
Principal Investigator: Tsitsi G Monera, BPharmHons, MPhil, PG Dip.         
Sponsors and Collaborators
University of Zimbabwe
State University of New York at Buffalo
Biomedical Research and Training Institute
Investigators
Principal Investigator: Tsitsi G Monera, BPharmHons, MPhil, PG Dip. University of Zimbabwe
  More Information

Publications:
Responsible Party: Tsitsi Grace Monera, Ms, University of Zimbabwe
ClinicalTrials.gov Identifier: NCT01410058     History of Changes
Other Study ID Numbers: MO 001
Study First Received: August 3, 2011
Last Updated: August 8, 2013
Health Authority: Zimbabwe: Medical Research Council

Keywords provided by University of Zimbabwe:
HIV
antiretroviral drug interaction
herbal medicine
pharmacokinetics
herbal pharmacology

Additional relevant MeSH terms:
Nevirapine
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 28, 2014