Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction

NCT01410058 | Completed Results DMC

• 1 other identifier: MO 001
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; antiretroviral drug interaction; herbal medicine; pharmacokinetics; herbal pharmacology

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (day 22), Post-moringa (day 35)

Secondary Outcomes (1)

• C12h

  Baseline (Day 22); Post-moringa (Day 35)

Other Outcomes (1)

• Cmax

  Baseline (day 22), Post-moringa (day 35)

Study Arms (2)

Nevirapine

HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder

Dietary Supplement: Moringa oleifera; Drug: Nevirapine 200Mg Oral Tablet

Efavirenz

HIV positive patients on efavirenz containing regimen, taking Moringa oleifera

Dietary Supplement: Moringa oleifera; Drug: Efavirenz 600mg

Interventions

Moringa oleifera DIETARY_SUPPLEMENT

leaf powder, 1.85g once daily, hard gelatin capsules

Also known as: moringa, drumstick tree, horseradish tree

Efavirenz; Nevirapine

Efavirenz 600mg DRUG

Efavirenz 600mg based regimen

Efavirenz

Nevirapine 200Mg Oral Tablet DRUG

Nevirapine 200mg based regimen

Nevirapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV Opportunistic infections clinic

You may qualify if:

• HIV positive,
• ≥ 4 weeks on Nevirapine or , ≥ 2 weeks on Efavirenz containing regimen,
• Supplements HAART with Moringa oleifera.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zimbabwe: lead
• State University of New York at Buffalo: collaborator
• Biomedical Research and Training Institute: collaborator

Study Sites (1)

Parirenyatwa Hospital OI Clinic

Harare, Zimbabwe

Location

Related Publications (5)

• 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.

  PMID: 17089328 BACKGROUND

• Sebit 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.

  PMID: 11317592 BACKGROUND

• van 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.

  PMID: 16877262 BACKGROUND

• Monera-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.

  PMID: 28293270 DERIVED

• Monera-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.

  PMID: 28250958 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, urine

MeSH Terms

Interventions

flocculant protein MO 2.1, Moringa oleifera; efavirenz; Nevirapine; Tablets

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Tsitsi G Monera-Penduka
• Organization: University of Zimbabwe College of Health Sciences

moneratg@yahoo.co.uk

307148

Study Officials

• Tsitsi G Monera, BPharmHons, MPhil, MSc CT

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-03

Locations

ZI (1)