Clinical Trial of antiretroviral effects of the Medicinal S

Clinical Trial of antiretroviral effects of the Medicinal S Clinical Trial of antiretroviral effects of the Medicinal S - Start

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Clinical Trial of antiretroviral effects of the Medicinal S - Description

. . M. C. O. . Ezeibe. and I. J. . Ogbonna. Department of Veterinary Medicine,. Michael . Okpara. University of Agriculture,. Nigeria.. ID: 565299 Download Presentation

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Clinical Trial of antiretroviral effects of the Medicinal S




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Slide1

Clinical Trial of antiretroviral effects of the Medicinal Synthetic Aluminum-Magnesium Silicate.

M. C. O.

Ezeibe

and I. J.

Ogbonna

Department of Veterinary Medicine,

Michael

Okpara

University of Agriculture,

Nigeria.

Background

Antiviral therapies (AVTs) for HIV/AIDS should be antiviral agents (AVA) that act by physical effects :

Prolonged medication needed

.

Biochemical effects have some harm

to

normal

cells.

V

iral

biochemistry

change so, they can resist

existing AVTs

.

What is AVA ? – Inhibition of :

* Attachment

of viruses to cells,

*Virus-cell

fusion,

* Viral

un-coating and/or

Reverse transcription of viral genomic RNAs (1

).

For an

AVA

to be AVT : - Must

be safe to animal cells

Aluminum-magnesium

s

ilicate

(AMS) is safe to normal cells (2).

It

is already in use as

;

*

Antidiarrhea

therapy.

* As

binder to make tablet dosage forms.

* To

aid disintegration of capsules when swallowed.

* To

stabilize emulsions ( 3

).

How does AMS act as

an AVA

?

Platelets of AMS molecules have –

ve

electrical charges on their surfaces and the +

ve

charges on their edges (

3). And

Every virus is electrically charged ( 4 ). 

HIV has +

ve

electrical charges (5).

Slide2

Abnormal cells (virus-infected, cancer)

have -

ve

electrical charges

(6

).

Platelets of AMS molecules are only 0.96 nm thick (3) =

Nanoparticles

( 7 ). 

N

anoparticles

cross physiological barriers to reach viruses and abnormal cells in all organs.

AMS disintegrates capsules. So, it may also destroy infected cells and cancer cells.

Destroying infected cells unmasks intracellular viruses. It then

adsorbs out

extracellular viruses to prevent establishment of new foci of

their infections.

AMS

also stabilizes chemotherapeutics to prolong their

bioavailability,

thus leading to more effective treatment of secondary infections.

Summary of qualities of AMS

as

AVT:

It is safe for use as medicine,

It reaches and destroys infected cells anywhere in the body

and

so, unmasks “hidden infections”.

It inhibits viruses by a physical process (not biochemical),

It

potentiates antimicrobials against secondary infections

.

Why

Medicinal synthetic Aluminum-magnesium silicate(MSAMS)

?

Use

of natural

AMS as

medicine is limited by impurities it contains (3)

Before

AMS is used as medicine or in medicine formulations, it is processed to improve its

purity.

Alternatively,

Pure

form of AMS should be

synthesized.

Nigeria

does not have deposits of AMS {Al

2

Mg

3

(SiO

4

)

3

}.

But

it has Aluminum silicate {Al

4

(SiO

4

)

3

} and Magnesium silicate (Mg

2

SiO

4

) which are already purified and are being used as medicines.

So, Aluminum

silicate and Magnesium silicate were reacted to get the

MSAMS

:

Al

4

(SiO

4

)

3

+ 3Mg

2

SiO

4

→ 2Al

2

Mg

3

(SiO

4

)

3

–(8).

Slide3

Assessment of the MSAMS as a medicine:

1. Is it AVA ?

i

. In

vitro

tests

Incubating

viral samples with the

Medicinal

synthetic

AMS l

ed to significant reduction of titers of both RNA and DNA viruses (

Ezeibe

et al

2009a, 2009b, 2010a, 2010b, 2011a, 2012a, 2013a, 2014

).

ii. In

vivo

tests

The

Medicinal synthetic AMS

cured

infections of both RNA and DNA viruses

- NDV, IBDV and CPV

(

Ezeibe

et al

2009b, 2010a ,

Ezeibe

et al

, 2010b).

2. Is it

an adjuvant

?

Antibiotic

(

Ampicillin

),

Anthelminthic

(

Piparazine

),

antiprotozoan

(

Sulphadimidine

) stabilized with

the

MSAMS

reduced infections by ≥ 95 %, at 75 % of their normal doses (

Ezeibe

et al

2011 b, 2012 b, 2012 c). Also,

synergy between a formulation of

A

mpicillin

in the

MSAMS

and immune stimulants, led to reduction of infection of an

A

mpicillin

-resistant

E.coli

isolate by 95.8% at 75 % of normal dose of

A

mpicillin

(

Ezeibe

et al,

2013 b).

3. Is it safe ?

Chicks

and dogs treated with the

MSAMS

and rats and mice experimentally dosed with it showed no adverse drug reaction (

Ezeibe

et al,

2009 a, 2010 a, 2010 b).

1(

i&ii

) + 2 + 3

=

MSAMS - an AVT

Tests of

antiretroviral

effects of the

MSAMS.

i

.

In vitro

:

 

HIV positive plasma

+MS

AMS

(1 hour at

room

temperature).

 

Repeat of the incubation (supernatants) .

HIV titers of

supernatants(1&2)

and

their

controls

tested

by direct passive

hemagglutination

test (

Ezeibe

,

et al

2013 c

).

ii. Clinical

trial of

antiretroviral efficacy:

MSAMS-

Ampicillin

trihydrate

formulation

(

Antivirt

A

®

) and

the MSAMS alone (

Antivirt

B

®

) were used.

Slide4

Journal publications which reported that AMS is safe for use as medicine and those that reported antiviral

effects

of the MSAMS were used to counsel HIV/AIDS patients and their physicians

.

Volunteers applied

through their

physicians.

Each patient had his/her

plasma

tested for HIV viral load

(RNA /ml

) before commencement of the treatment.

For

first 4 weeks,:

50 mg/kg

(MSAMS)

,

7.5 mg/kg

(MSAMS-stabilized

Ampicillin

trihydrate

) and

immune stimulants.

Thereafter :

50 mg/kg

(MSAMS)

and immune stimulants, only.

The viral load test was repeated

regularly.

When viral load of a patient reduced bellow 50/ml

the

treatment was continued for additional four weeks and stopped.

Results.

 

In

vitro

(

Tables 1 and 2), HIV titer of one plasma sample increased from 32 to ≥4096 when incubated with the MSAMS and reduced to 16 (99.60 % reduction) when the incubation was repeated. Titers of the other samples, also increased significantly (P = 0.009) from a mean of 4.00±1.63 to 14.00±2.00, when incubated with the

MSAMS.

When

incubation

was repeated, the

mean titers

reduced

(P=0.024

) from

14.00±2.00

to

6.50±1.50.

 

In vivo

(Tables 3 and 4

) mean

viral

load

increased

(

P=0.006) from 498.50 ± 33.37 to

1,072.50±184.55 after

3.75 ±2.06

weeks but

it

reduced (

P=0.04) to 407.33 ±297.27 (18.29

%) when treatment-duration increased to

6.67±2.31 weeks.

Slide5

When the treatment-duration further increased, to 10.40±6.10 weeks, the rate of viral load-reduction improved to 98.60% (19,500 ±295.80 to 270.80 ±412.80). Table 1. Human immune deficiency virus titres of plasma samples incubated with the Medicinal synthetic Aluminum-magnesium silicate Plasma samples HIV titer Control Incubated with MSAMS. 1 0 8 2 4 16 3 8 16 4 4 16 Means 4.00±1.63 14.00±2.00 Table 2. Human immune deficiency virus titres of plasma samples, on which incubation with the Medicinal synthetic Aluminum-magnesium silicate was repeated Plasma samples HIV titer Number of incubations with AMS: 1 2 1 8 2 2 16 8 3 16 8 4 16 8 Means 14.00±2.00 6.50±1.50

Slide6

Table 3:

Initial increases and reductions in viral loads of HIV-patients treated with the

Medicinal synthetic Aluminum-magnesium silicate

Before treatment Increase (treatment-duration) Reduction (treatment-duration)

500 1,000(1) 70(4)

518 936(6) -

451 1009(4) 631(8)

525 1345(4) 521(8)

Mean 498.50±33.37

a

1,072.50±184.5

b

(3.75±2.06) 407.33±297.27

c

(6.67±2.31)

Table 4

: Viral loads of HIV-patients treated with the

Medicinal synthetic Aluminum-magnesium silicate

Before treatment Duration of treatment(weeks)

4,000 1,000(8)

1,000 40(8)

70,000 200(12)

22,000 44(20)

500 70(4)

Mean 19,500.00 ± 29,580.00

a

270.80±412.80

b

(10.40 ±6.10)

Slide7

Conclusions

Initial increases in viral titers (

in vitro

) and in viral loads (

in vivo

) suggest that the

MSAMS

  destroys infected cells to unmask HIV “hidden in cells” before adsorbing them out.

 

Viral load-reduction rate of 98.60% got after treatment for 10.40±6.10 weeks was significantly (P=0.004) higher than the 18.28% got in 6.67 ±2.31weeks, suggesting that the longer the duration of treatment the more the population of HIV mopped out.

Reduction of viral loads below 50 RNAs per ml of plasma of HIV +

ve

persons means that the MSAMS is a highly active anti-retroviral therapy(9).

 

The MSAMS:

Unmasks HIV “hidden in cells”.

 Acts on viruses ,in blood and in organs .

Has access to every organ and system(

Nanoparticles

)

Mops out HIV continuously

 

To achieve cure of HIV/AIDS - medication long enough after viral

load reduction <

50 /ml (by the old technique) or to undetectable level (by the new technique).

The patients whose viral loads reduced to 40/ml and 44/ml and were treated for additional 4 weeks have remained healthy without antiretroviral medication, 16 months and 10 months , respectively.

 

What remains is to confirm HIV status of treated patients by antigen tests, instead of antibody tests, because antibodies remain in blood, long after termination of viral infections.

?

Slide8

REFERENCES

 

Brooks, G.F.

Medical Microbiology

.

21st Edition, Mc

Graw

Hill Education Inc., San

Franscisco

: 1998.

 

Cann

, A.J. Principles of molecular biology. Academic Press, San Diego; 1993.

Cristina, E., Ivan, P., Kevin, R.

Nanomaterials

and

nanoparticles

: Sources and toxicity.

Biointerphases

, 2007;2:MR17-MR71. dol:10.1116/12815690.PMD.20419892.

Dennis V. P and

Lasse

, K. (2013). Students discover method to kill cancer. M. Sc thesis, University of Engineering Finland. 

Elmore, A. R. Cosmetics ingredients review experts panel’s report. International Journal of Toxicology. 2003;22:37-102.

 

Mark-

Cichocki

, R. N. HAART –Highly active anti-retroviral therapy.

aids.about.com: (

2014).

Vanderbilt, R.T.

Veegum

—The versatile ingredient for pharmaceutical formulations. Inc. Technical Literature; 2012.

  

Yokoyama, M. Structural mechanisms of immune evasion of HIV 1

gp

120 by genomic computational and experimental science.

Uirusu

. 2011;61(1):49-57.


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