N/A
N=19
Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01410058 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: AUC — 94.17; 34.67; 100.44; 32.58 h*microgram/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Moringa oleifera (Dietary_supplement); Efavirenz 600mg (Drug); Nevirapine 200Mg Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Zimbabwe
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC |
94.17; 34.67; 100.44; 32.58 | — |
| SECONDARY C12h |
7.30; 2.96; 7.55; 2.53 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01410058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.