Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03366922
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2017-11-20
Brief Title:
Evaluation of Artemisia Annua and Moringa
Sponsor:
Mbarara University of Science and Technology
Organization:
Mbarara University of Science and Technology
Study Overview
Official Title:
EVALUATION OF THE EFFECT OF ARTEMISIA ANNUA AND MORINGA OLEIFERA ON IMMUNOLOGICAL RESPONSE IN HAART HIV PATIENTS at MRRH
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Artemisia annua L is a medicinal plant traditionally used for treatment of malaria and other diseases in China The extract of leaves of the plant has been demonstrated in-vitro to have potent anti HIV effects and in vivo to improve levels of lymphocytes in laboratory animals Effect on lymphocyte stimulation has also been observed in non HIV persons taking the leaves of the plant as a tea for malaria prophylaxis in Uganda
Objective To determine the effect of Aannua L and Moringa oleifera leaf powder on CD4 cell count and other immunological indices in HAART HIV patients
Materials and Methods In this study Artemisia annua leaf powder and Moringa leaf powder will be investigated The study will be a three arm randomized Phase II study involving adult patients with HIV-infection on HAART with CD4 below 350 The CD4 cell count and other immunological indices in patients receiving HAART will be compared with those patients receiving additionally Artemisia annua powder with Moringa oleifera powder or Artemisia annua powder alone The study will be conducted at the HIV clinic in Mbarara Regional Referral Hospital while laboratory tests will be done at Mbarara University of Science and Technology clinical and pharmaceutical sciences laboratories
Expected outcome The primary outcome will be change in mean Median CD 4 cell count Secondary outcomes will be mean or median changes viral load complete blood count and other HIV associated immunological indices Performance status and incidence of adverse effects like nausea diarrhoea weight gain and or loss
Expected benefits Adequate immunological recovery is one of the desired outcomes in HIV care HAART combinations do not directly aid immunological recovery and some patients fail to have adequate immunological recovery despite adequate suppression of viral load There are many patients using herbal supplements but there is limited scientific clinical evidence on the benefit of these supplements in HAART patients
Objective To determine the effect of Aannua L and Moringa oleifera leaf powder on CD4 cell count and other immunological indices in HAART HIV patients
Materials and Methods In this study Artemisia annua leaf powder and Moringa leaf powder will be investigated The study will be a three arm randomized Phase II study involving adult patients with HIV-infection on HAART with CD4 below 350 The CD4 cell count and other immunological indices in patients receiving HAART will be compared with those patients receiving additionally Artemisia annua powder with Moringa oleifera powder or Artemisia annua powder alone The study will be conducted at the HIV clinic in Mbarara Regional Referral Hospital while laboratory tests will be done at Mbarara University of Science and Technology clinical and pharmaceutical sciences laboratories
Expected outcome The primary outcome will be change in mean Median CD 4 cell count Secondary outcomes will be mean or median changes viral load complete blood count and other HIV associated immunological indices Performance status and incidence of adverse effects like nausea diarrhoea weight gain and or loss
Expected benefits Adequate immunological recovery is one of the desired outcomes in HIV care HAART combinations do not directly aid immunological recovery and some patients fail to have adequate immunological recovery despite adequate suppression of viral load There are many patients using herbal supplements but there is limited scientific clinical evidence on the benefit of these supplements in HAART patients
Detailed Description:
HIV still remains a major public health burden in Uganda and Africa as a whole It is estimated that about 369 million persons are infected worldwide with majority being in Africa While most HIV persons in Uganda initiate HAART late sometimes with CD4 cell count below 350 making their immunological recovery very poor and putting them at higher risk of opportunistic infections there are no established medicines for enhancement of immune responses
Indeed a number of medicinal plants are reported to have anti-HIV effects and immune enhancement effect in vitro however few to none have had their potential demonstrated in a controlled clinical study This study will investigate Aannua supplemented with Moringa oleifera Artemisia annua medicinal plant has been demonstrated to have immunological effects in laboratory studies as well as anti-HIV effects in vitro Lubbe et al 2012 Moringa oleifera has been reported to be used in up to 80 of HIV patients in Africa Lubinga et al 2012 and thus will be investigated as a nutritional supplement Although there is improved access to testing and hence timely diagnosis for HIV with increased roll out of anti-retroviral therapy many patients in resource limited settings still initiate HAART when the HIV-infection is in advanced stage Initiation of HAART in patients with advanced HIV-infection has previously been associated with sub-optimal immunological recovery Reda et al 2012 In addition in Uganda many HIV patients are reported to use herbal medicines in addition to HAART including Aloe vera Vernonia amygdalina and Moringa oleifera Lubinga et al 2012 The challenge is that the clinical benefits of most of these herbal medicines remain unknown as well as their potential interactions with HAART Artemisia annua powder which has been shown in vitro to have anti-HIV effects and in vivo to cause increase in monocytes and lymphocytes level Lubbe et al 2012 Ndhlala et al 2016 is used by some HIV patients in Uganda claiming to improve their quality of life Lubinga et al 2012 However there are no data from controlled studies to prove these claims and thus enable adoption or rejection of Artemisia annua powder and Moringa oleifera as an adjunct to HIV treatment Proof of beneficial effects of a given herbal remedy would provide an alternative to use of unproven herbal products as it is the case currently Artemisia annua medicinal plant has been demonstrated to have immunological effects in laboratory studies as well as anti-HIV effects in vitro Lubbe et al 2012 Has a short plasma half-life When given orally or rectally dihydroartemisinin was safe and showed higher bioavailability in humans than artemisinin in an early pharmacokinetic study by Zhao et al 1993 The Cmax Tmax and T12 for orally delivered dihydroartemisinin were 013-071 mgL 133 h approximately 16 h respectively for pure artemisinin they were 009 mgL 15 h and 227 h respectively Alin et al 1996 compared orally delivered artemisinin and artemisinin-mefloquine combination therapy for treatment of P falciparum malaria Infected and uninfected patients had similar pharmacokinetic parameters After a single dose bioavailability of artemisinin was not altered In the Ilet et al2005 review of pharmacokinetic parameters of artemisinin and its derivatives oral pure artemisinin doses ranged from about 6-11 mg kgL in healthy subjects and Cmax was 015-039 mgL Dose seemed to have no major effect An earlier study by Ashton et al 1998compared increasing artemisinin doses of 250 500 and 1000 mg per person and both Cmax and T12 showed dose-dependent increases of 021 045 and 079 mgL and 138 20 and 28 h respectively but Tmax remained relatively constant at 23-28 h et al 2011 2012 has also found Artemisia tea at 25g dried leaves per adult infusion dose with 55-100mg artemisininL safe Other pharmacokinetic studies have been duly added in the background section and show that artemisinin delivered by oral consumption of Artemisia annua dried leaves or encapsulated dried leaves of Artemisia Annua are generally safe Weather et al 2014 Elfawal et al 2015 Desroslera and Weathers 2016
Moringa oleifera on the other hand has been reported to be used as a nutritional supplement and management of HIV infections in up to 80 of HIV patients in Africa Monera et al 2008 Lubinga et al 2012 Popoola et al 2013 Ndhlala et al 2016 Roelofsen et al 2017 Asare and colleagues 2012 also confirmed that intake of Moringa Oleifera is very safe at levels 1000 mgkg bwt Monera and colleagues have also found out in a cross-over study that Co administration of Moringa oleifera Lam leaf powder at the traditional dose did not alter the steady state pharmacokinetics of nevirapine in HIV infected adults Monera Penduka et al 2017
A3 OBJECTIVES List the major objectiveshypothesis which have governed your choice of study design General objective
To determine the effect of Artemisia annua powder and Moringa oleifera on immunological and haematological response in patients on HAART
Specific objectives
1 To determine effect of Artemisia annua in combination with Moringa oleifera on CD4 cell count in HIV patients on HAART
2 To determine the effect of Artemisia annua with Moringa oleifera on viral load in patients on HAART
3 To determine the effect of Artemisia annua with Moringa oleifera on full blood count and immunogloblins associated with HIV infections in HAART patients
4 To determine the effect of Artemisia annua and Moringa oleifera on antiretroviral plasma drug level in patients on first line ART UCG 2016
5 To determine the effect of Artemisia annua and Moringa oleifera on performance status and quality of life in HAART patients
6 To profile any adverse effects of Artemisia annua and Moringa oleifera HIV patients on HAART
Indeed a number of medicinal plants are reported to have anti-HIV effects and immune enhancement effect in vitro however few to none have had their potential demonstrated in a controlled clinical study This study will investigate Aannua supplemented with Moringa oleifera Artemisia annua medicinal plant has been demonstrated to have immunological effects in laboratory studies as well as anti-HIV effects in vitro Lubbe et al 2012 Moringa oleifera has been reported to be used in up to 80 of HIV patients in Africa Lubinga et al 2012 and thus will be investigated as a nutritional supplement Although there is improved access to testing and hence timely diagnosis for HIV with increased roll out of anti-retroviral therapy many patients in resource limited settings still initiate HAART when the HIV-infection is in advanced stage Initiation of HAART in patients with advanced HIV-infection has previously been associated with sub-optimal immunological recovery Reda et al 2012 In addition in Uganda many HIV patients are reported to use herbal medicines in addition to HAART including Aloe vera Vernonia amygdalina and Moringa oleifera Lubinga et al 2012 The challenge is that the clinical benefits of most of these herbal medicines remain unknown as well as their potential interactions with HAART Artemisia annua powder which has been shown in vitro to have anti-HIV effects and in vivo to cause increase in monocytes and lymphocytes level Lubbe et al 2012 Ndhlala et al 2016 is used by some HIV patients in Uganda claiming to improve their quality of life Lubinga et al 2012 However there are no data from controlled studies to prove these claims and thus enable adoption or rejection of Artemisia annua powder and Moringa oleifera as an adjunct to HIV treatment Proof of beneficial effects of a given herbal remedy would provide an alternative to use of unproven herbal products as it is the case currently Artemisia annua medicinal plant has been demonstrated to have immunological effects in laboratory studies as well as anti-HIV effects in vitro Lubbe et al 2012 Has a short plasma half-life When given orally or rectally dihydroartemisinin was safe and showed higher bioavailability in humans than artemisinin in an early pharmacokinetic study by Zhao et al 1993 The Cmax Tmax and T12 for orally delivered dihydroartemisinin were 013-071 mgL 133 h approximately 16 h respectively for pure artemisinin they were 009 mgL 15 h and 227 h respectively Alin et al 1996 compared orally delivered artemisinin and artemisinin-mefloquine combination therapy for treatment of P falciparum malaria Infected and uninfected patients had similar pharmacokinetic parameters After a single dose bioavailability of artemisinin was not altered In the Ilet et al2005 review of pharmacokinetic parameters of artemisinin and its derivatives oral pure artemisinin doses ranged from about 6-11 mg kgL in healthy subjects and Cmax was 015-039 mgL Dose seemed to have no major effect An earlier study by Ashton et al 1998compared increasing artemisinin doses of 250 500 and 1000 mg per person and both Cmax and T12 showed dose-dependent increases of 021 045 and 079 mgL and 138 20 and 28 h respectively but Tmax remained relatively constant at 23-28 h et al 2011 2012 has also found Artemisia tea at 25g dried leaves per adult infusion dose with 55-100mg artemisininL safe Other pharmacokinetic studies have been duly added in the background section and show that artemisinin delivered by oral consumption of Artemisia annua dried leaves or encapsulated dried leaves of Artemisia Annua are generally safe Weather et al 2014 Elfawal et al 2015 Desroslera and Weathers 2016
Moringa oleifera on the other hand has been reported to be used as a nutritional supplement and management of HIV infections in up to 80 of HIV patients in Africa Monera et al 2008 Lubinga et al 2012 Popoola et al 2013 Ndhlala et al 2016 Roelofsen et al 2017 Asare and colleagues 2012 also confirmed that intake of Moringa Oleifera is very safe at levels 1000 mgkg bwt Monera and colleagues have also found out in a cross-over study that Co administration of Moringa oleifera Lam leaf powder at the traditional dose did not alter the steady state pharmacokinetics of nevirapine in HIV infected adults Monera Penduka et al 2017
A3 OBJECTIVES List the major objectiveshypothesis which have governed your choice of study design General objective
To determine the effect of Artemisia annua powder and Moringa oleifera on immunological and haematological response in patients on HAART
Specific objectives
1 To determine effect of Artemisia annua in combination with Moringa oleifera on CD4 cell count in HIV patients on HAART
2 To determine the effect of Artemisia annua with Moringa oleifera on viral load in patients on HAART
3 To determine the effect of Artemisia annua with Moringa oleifera on full blood count and immunogloblins associated with HIV infections in HAART patients
4 To determine the effect of Artemisia annua and Moringa oleifera on antiretroviral plasma drug level in patients on first line ART UCG 2016
5 To determine the effect of Artemisia annua and Moringa oleifera on performance status and quality of life in HAART patients
6 To profile any adverse effects of Artemisia annua and Moringa oleifera HIV patients on HAART
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None