Trial Outcomes & Findings for Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction (NCT NCT01410058)
NCT ID: NCT01410058
Last Updated: 2019-04-02
Results Overview
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
COMPLETED
19 participants
Baseline (day 22), Post-moringa (day 35)
2019-04-02
Participant Flow
HIV-infected male and female adults reporting for routine HIV clinic visits at a referral hospital in Zimbabwe were identified through an interviewer-administered questionnaire.
The study had a minimum 3-week herbal medication wash out period prior to the first dosing to reduce the possibility of carryover from any type of previously used moringa or other herbal medication, so the participants would have the same baseline.
Participant milestones
| Measure |
Nevirapine
HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
|
Efavirenz
HIV positive patients on efavirenz containing regimen, taking Moringa oleifera leaf powder
|
|---|---|---|
|
Washout Day 0
STARTED
|
13
|
6
|
|
Washout Day 0
COMPLETED
|
13
|
6
|
|
Washout Day 0
NOT COMPLETED
|
0
|
0
|
|
Baseline Day 22
STARTED
|
13
|
6
|
|
Baseline Day 22
COMPLETED
|
13
|
6
|
|
Baseline Day 22
NOT COMPLETED
|
0
|
0
|
|
Day 35
STARTED
|
13
|
6
|
|
Day 35
COMPLETED
|
13
|
6
|
|
Day 35
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction
Baseline characteristics by cohort
| Measure |
Nevirapine
n=11 Participants
HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules
|
Efavirenz
n=6 Participants
HIV positive patients on efavirenz containing regimen, taking Moringa oleifera
Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 8 • n=99 Participants
|
43 years
STANDARD_DEVIATION 8 • n=107 Participants
|
44 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Weight
|
63.5 kg
STANDARD_DEVIATION 7.5 • n=99 Participants
|
72.5 kg
STANDARD_DEVIATION 17.0 • n=107 Participants
|
65.9 kg
STANDARD_DEVIATION 12.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (day 22), Post-moringa (day 35)Population: Only participants with complete data were included
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
Outcome measures
| Measure |
Nevirapine
n=11 Participants
HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
Moringa oleifera: leaf powder
|
Efavirenz
n=6 Participants
HIV positive patients on efavirenz containing regimen, taking Moringa oleifera
Moringa oleifera: leaf powder
|
|---|---|---|
|
AUC
Baseline (Day 22)
|
94.17 h*microgram/mL
Geometric Coefficient of Variation 25.24
|
34.67 h*microgram/mL
Geometric Coefficient of Variation 24.85
|
|
AUC
Post-moringa (Day 35)
|
100.44 h*microgram/mL
Geometric Coefficient of Variation 27.65
|
32.58 h*microgram/mL
Geometric Coefficient of Variation 38.75
|
SECONDARY outcome
Timeframe: Baseline (Day 22); Post-moringa (Day 35)Population: Only patients with complete data were included in the analysis.
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
Outcome measures
| Measure |
Nevirapine
n=11 Participants
HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
Moringa oleifera: leaf powder
|
Efavirenz
n=6 Participants
HIV positive patients on efavirenz containing regimen, taking Moringa oleifera
Moringa oleifera: leaf powder
|
|---|---|---|
|
C12h
Baseline (Day 22)
|
7.30 microgram/mL
Geometric Coefficient of Variation 25.85
|
2.96 microgram/mL
Geometric Coefficient of Variation 18.75
|
|
C12h
Post-moringa (Day 35)
|
7.55 microgram/mL
Geometric Coefficient of Variation 28.56
|
2.53 microgram/mL
Geometric Coefficient of Variation 21.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day 22), Post-moringa (day 35)Population: Only patients with complete data were included.
Maximum plasma concentration post does, 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
Outcome measures
| Measure |
Nevirapine
n=11 Participants
HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
Moringa oleifera: leaf powder
|
Efavirenz
n=6 Participants
HIV positive patients on efavirenz containing regimen, taking Moringa oleifera
Moringa oleifera: leaf powder
|
|---|---|---|
|
Cmax
Baseline (Day 22)
|
9.92 microgram/mL
Geometric Coefficient of Variation 26.93
|
5.08 microgram/mL
Geometric Coefficient of Variation 22.95
|
|
Cmax
Post-moringa (Day 35)
|
10.57 microgram/mL
Geometric Coefficient of Variation 29.62
|
5.51 microgram/mL
Geometric Coefficient of Variation 38.28
|
Adverse Events
Nevirapine
Efavirenz
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nevirapine
n=13 participants at risk
HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder
Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules
|
Efavirenz
n=6 participants at risk
HIV positive patients on efavirenz containing regimen, taking Moringa oleifera
Moringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules
|
|---|---|---|
|
Renal and urinary disorders
Altered creatinine clearance
|
0.00%
0/13 • Adverse event data was collected at baseline (day 22) and at final visit (day 35).
All participants were monitored for adverse events throughout the study. The study medical officer documented any adverse events observed from clinical examinations or self-reported by the participants at each of the two visits. Urinalysis and Serum biochemistries were determined and graded based on CTCAE.
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected at baseline (day 22) and at final visit (day 35).
All participants were monitored for adverse events throughout the study. The study medical officer documented any adverse events observed from clinical examinations or self-reported by the participants at each of the two visits. Urinalysis and Serum biochemistries were determined and graded based on CTCAE.
|
|
Hepatobiliary disorders
Elevated liver transaminase
|
30.8%
4/13 • Number of events 5 • Adverse event data was collected at baseline (day 22) and at final visit (day 35).
All participants were monitored for adverse events throughout the study. The study medical officer documented any adverse events observed from clinical examinations or self-reported by the participants at each of the two visits. Urinalysis and Serum biochemistries were determined and graded based on CTCAE.
|
66.7%
4/6 • Number of events 4 • Adverse event data was collected at baseline (day 22) and at final visit (day 35).
All participants were monitored for adverse events throughout the study. The study medical officer documented any adverse events observed from clinical examinations or self-reported by the participants at each of the two visits. Urinalysis and Serum biochemistries were determined and graded based on CTCAE.
|
Additional Information
Tsitsi G Monera-Penduka
University of Zimbabwe College of Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place