HIVNCT01410058
Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction
An observational study of HIV, run by University of Zimbabwe at 1 site in Zimbabwe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Moringa oleifera, Efavirenz 600mg and Nevirapine 200Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 19 participants
- Where
- 1 siteZimbabwe
- Study dates
- Jan 2013to Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV Opportunistic infections clinic
Who may be able to join
- HIV positive,
- ≥ 4 weeks on Nevirapine or , ≥ 2 weeks on Efavirenz containing regimen,
- Supplements HAART with Moringa oleifera.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- To compare the steady-state pharmacokinetics of nevirapine and efavirenz in HIV-positive patients before and after supplementation with Moringa oleifera leaf powder
- To compare the single dose pharmacokinetics of nevirapine and efavirenz in rat models before and after supplementation with Moringa oleifera leaf powder Secondary objectives
- To determine the bioavailability of Moringa oleifera leaf powder in humans after oral dosing using beta carotene as a bio marker.
- To compare urine chemistries and liver function tests in HIV patients before and after supplementation with Moringa oleifera leaf powder
- To determine the presence of any genetic variation in the participants in the genes that code for CYP3A4 and CYP2B6
- Conditions
- HIV
- Being tested
- Moringa oleifera, Efavirenz 600mg, Nevirapine 200Mg Oral Tablet
- Keywords
- HIV, antiretroviral drug interaction, herbal medicine, pharmacokinetics, herbal pharmacology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleiferaDietary supplement
Also called moringa, drumstick tree, horseradish tree
leaf powder, 1.85g once daily, hard gelatin capsules
Efavirenz 600mgDrug
Efavirenz 600mg based regimen
Nevirapine 200Mg Oral TabletDrug
Nevirapine 200mg based regimen
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine | HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder Receives: Dietary Supplement: Moringa oleifera; Drug: Nevirapine 200Mg Oral Tablet | |
| Efavirenz | HIV positive patients on efavirenz containing regimen, taking Moringa oleifera Receives: Dietary Supplement: Moringa oleifera; Drug: Efavirenz 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the plasma concentration time curve, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h
Measured: Baseline (day 22), Post-moringa (day 35)
Secondary outcomes (1)
C12h
plasma concentration 12h post dose, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h
Measured: Baseline (Day 22); Post-moringa (Day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York at Buffalo, Biomedical Research and Training Institute
- Responsible party
- Principal investigator, Tsitsi Grace Monera, University of Zimbabwe
- Investigators
- Tsitsi G Monera, BPharmHons, MPhil, MSc CT, Principal investigator, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410058
- Sponsor's protocol ID
- MO 001
- Status last verified
- Mar 2019
- First submitted
- 3 Aug 2011
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Anwar F, Latif S, Ashraf M, Gilani AH. Moringa oleifera: a food plant with multiple medicinal uses. Phytother Res. 2007 Jan;21(1):17-25. doi: 10.1002/ptr.2023.
PubMed 17089328Sebit MB, Chandiwana SK, Latif AS, Gomo E, Acuda SW, Makoni F, Vushe J. Quality of life evaluation in patients with HIV-I infection: the impact of traditional medicine in Zimbabwe. Cent Afr J Med. 2000 Aug;46(8):208-13.
PubMed 11317592van den Bout-van den Beukel CJ, Koopmans PP, van der Ven AJ, De Smet PA, Burger DM. Possible drug-metabolism interactions of medicinal herbs with antiretroviral agents. Drug Metab Rev. 2006;38(3):477-514. doi: 10.1080/03602530600754065.
PubMed 16877262Monera-Penduka TG, Maponga CC, Wolfe AR, Wiesner L, Morse GD, Nhachi CF. Effect of Moringa oleifera Lam. leaf powder on the pharmacokinetics of nevirapine in HIV-infected adults: a one sequence cross-over study. AIDS Res Ther. 2017 Mar 14;14:12. doi: 10.1186/s12981-017-0140-4. eCollection 2017.
PubMed 28293270Monera-Penduka TG, Maponga CC, Morse GD, Nhachi CFB. Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients. J Pharm Policy Pract. 2017 Feb 20;10:9. doi: 10.1186/s40545-017-0099-5. eCollection 2017.
PubMed 28250958
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moringa Oleifera (Moringa, Drumstick/Horseradish Tree) on The Pharmacokinetics of Efavirenz and Nevirapine In-vivo.
- ClinicalTrials.gov ID
- NCT01410058
- Acronym / sponsor ID
- MO 001
- Conditions
- HIV
- Keywords
- HIV, antiretroviral drug interaction, herbal medicine, pharmacokinetics, herbal pharmacology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Collaborators
- State University of New York at Buffalo, Biomedical Research and Training Institute
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Posted 2 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- To compare the steady-state pharmacokinetics of nevirapine and efavirenz in HIV-positive patients before and after supplementation with Moringa oleifera leaf powder
- To compare the single dose pharmacokinetics of nevirapine and efavirenz in rat models before and after supplementation with Moringa oleifera leaf powder Secondary objectives
- To determine the bioavailability of Moringa oleifera leaf powder in humans after oral dosing using beta carotene as a bio marker.
- To compare urine chemistries and liver function tests in HIV patients before and after supplementation with Moringa oleifera leaf powder
- To determine the presence of any genetic variation in the participants in the genes that code for CYP3A4 and CYP2B6
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nevirapine | – | Dietary Supplement: Moringa oleifera, Drug: Nevirapine 200Mg Oral TabletHIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder |
| Efavirenz | – | Dietary Supplement: Moringa oleifera, Drug: Efavirenz 600mgHIV positive patients on efavirenz containing regimen, taking Moringa oleifera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV Opportunistic infections clinic
Key inclusion criteria (3 listed)
- HIV positive,
- ≥ 4 weeks on Nevirapine or , ≥ 2 weeks on Efavirenz containing regimen,
- Supplements HAART with Moringa oleifera.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa oleiferaAlso: moringa, drumstick tree, horseradish treeleaf powder, 1.85g once daily, hard gelatin capsules | Dietary supplement | Efavirenz, Nevirapine |
| Efavirenz 600mgEfavirenz 600mg based regimen | Drug | Efavirenz |
| Nevirapine 200Mg Oral TabletNevirapine 200mg based regimen | Drug | Nevirapine |
Primary outcome
AUC
Time frame: Baseline (day 22), Post-moringa (day 35)
Area under the plasma concentration time curve, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h
1 secondary outcome
C12h
Time frame: Baseline (Day 22); Post-moringa (Day 35)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17089328Anwar F, Latif S, Ashraf M, Gilani AH. Moringa oleifera: a food plant with multiple medicinal uses. Phytother Res. 2007 Jan;21(1):17-25. doi: 10.1002/ptr.2023.
- Background: PubMed 11317592Sebit MB, Chandiwana SK, Latif AS, Gomo E, Acuda SW, Makoni F, Vushe J. Quality of life evaluation in patients with HIV-I infection: the impact of traditional medicine in Zimbabwe. Cent Afr J Med. 2000 Aug;46(8):208-13.
- Background: PubMed 16877262van den Bout-van den Beukel CJ, Koopmans PP, van der Ven AJ, De Smet PA, Burger DM. Possible drug-metabolism interactions of medicinal herbs with antiretroviral agents. Drug Metab Rev. 2006;38(3):477-514. doi: 10.1080/03602530600754065.
- Derived from this study: PubMed 28293270Monera-Penduka TG, Maponga CC, Wolfe AR, Wiesner L, Morse GD, Nhachi CF. Effect of Moringa oleifera Lam. leaf powder on the pharmacokinetics of nevirapine in HIV-infected adults: a one sequence cross-over study. AIDS Res Ther. 2017 Mar 14;14:12. doi: 10.1186/s12981-017-0140-4. eCollection 2017.
- Derived from this study: PubMed 28250958Monera-Penduka TG, Maponga CC, Morse GD, Nhachi CFB. Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients. J Pharm Policy Pract. 2017 Feb 20;10:9. doi: 10.1186/s40545-017-0099-5. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsitsi G Monera, BPharmHons, MPhil, MSc CT principal investigator
University of Zimbabwe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of Zimbabwe at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: Baseline (day 22), Post-moringa (day 35)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01410058, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.