The following is clinical studies carried out at the Kenya Medical Research Institute (KEMRI), subjects using VIUSID for the management of human immunodeficiency virus (HIV).

PRINCIPAL INVESTIGATORS:
1. Mr. Charles F.L. Mbakaya, MSc (Chemist) -KEMRI

CO-INVESTIGATOR:
1. Mr. Wilfred Kisingu, Dip (PHE) -KEMRI - September 30th 2002

CONCLUSIONS:

After the first 12 weeks of treatment with Viusid, all the opportunistic infections disappear and  they are not detected any more in any of the patients during the rest of the treatment.

During the 30 months, the average CD4 counts of all the treated patients remain  stable, at > 400.

From the beginning up to the end of the treatment, viral load goes down 60 %, being this  reduction more marked in the last 6 months (64.5 %).

In 19 % of the patients, viral load is undetectable (< 50 copies/ml). And in 30 % of the  patients, it is less than 630 copies/ml.

According to CDC classification, after 30 months of treatment with Viusid, the patients  of group A (15 % of all the patients) remain in the same group and some patients  (11 % of all the patients) of group B pass to group A.

There are no side effects and no resistance in any of the patients during the 30 months of treatment.

During the last 6 months, 81 % of the treated patients reduce their viral load. 

San Pedro de Sula, Honduras. C.A.

Researcher: Dr. José Roberto Trejo (Clinical Infectology). January 2000.

This study includes 24 patients, all of them HIV/AIDS positive and older than 18. Of the sample population, 9 patients are in triple combined therapy and 15 are not following any treatment except for that prescribed for the specific opportunistic illness concerned in their case.

With this sample, two groups were formed in accordance with the previous distinction, to evaluate if the effects produced may be attributed to the therapy received, to Viusid or to the effect of the combination of the two.

• Appetite: increased in both groups, being in the order of 89% among those who were in antiretroviral treatment and 80% among those who were not.
• Vital tone: 71% of the total number of patients improved in vital tone, which fact was reflected in a greater willingness to carry out physical activities, an improvement in anemic state and working capacity. The percentage was greater (77%) among those who were taking antiretroviral agents than among those who were not (67%). This situation was manifested after two weeks taking Viusid and maintained itself up to six weeks after the study was finished.
• Sleep: improvement in the hours of sleep and in its quality, 67% among those who were taking antiretroviral agents and 20% among those who were not.

Clinical improvement:

• Weight: 33% of the patients increased in weight, the gain of more than 2 Kg of body weight being understood as weight increase. The results were similar in both groups.
• Metabolic parameters: 75% increased their level of total proteins. 50% improved their hemoglobin at the end of the study in 2 or 3 g/dl. 62% improved in hematocrit, 54% increased platelets. The level of leucocytes increased in 50% of the patients, whereas 42% improved their hepatic function.
• Immunological parameters: only 12.5% of the patients increased their CD4 levels. 75% maintained these stable and 12.5% decreased them. We should indicate that these data are subject to an observation: the blood samples are moved over a great distance to carry out the tests and suffer changes that later on affect the results. We should as well indicate the use of laboratory techniques that are not on a par with the present state of these.3

Protocol of the Project for the clinical study and analysis of treatment with Nutritional Preparation (Viusid) in HIV patients.
Year 2000
Luis Moral Parras (Doctor in charge of the Medical Action Program and Complementary Medicines of the non-government civic association "Amigos" of Benidorm (Alicante), for HIV-AIDS infected persons.

A study having the following characteristics was carried out on 18 patients, ten male and eight female:

• One did not follow any pharmacological treatment
• Two had treatment with two inhibitors of inverse transcriptase
• Fourteen had HAART treatment with a protease inhibitor
• One had a triple treatment
• Eight were in treatment with homeopatic medicine

The treatment lasted three months with a dosage of 100 ml/day throughout each entire day.

Analytical tests were carried out at the start and the end of the treatment.

The data obtained about quality of life after the administration of Viusid were:

• increase of appetite
• increase of strength and muscular mass
• disappearance of nighttime sweating
• disappearance of anxiety
• improvement of sleep
• improvement of vital tone
• disappearance of diarrheas

In general, there was a self-perception of having greater willingness to do activity.

Evolution of immunological state:

• CD4 lymphocytes increased in 17 patients (94%), with average data of 678 CD4/mmc at the start to 841/mmc after three months.
• CD8 lymphocytes increased less than the CD4 lymphocytes. In 55% of the patients, it rose on average from 932 to 1013/mmc.
• the quotient CD4/CD8 increased in 83%, rising on average 0.7 to 0.9
• Viral charge was reduced 32.6% on average in 83% of the treated patients.

National Institute For Infectious Diseases "Prof Dr. Matei Bals". Bucharest 2000

Researcher: Prof. Dr. Mircea Chiotan.

The study was carried out on 60 hospitalized patients, its objectives being:

• The effectiveness of Viusid on different patients types of infectious illnesses: of medium severity, prolonged and chronic acute illnesses, chronic and severe illnesses, herpes zoster, HIV, ...
• Estimation of dosages to be administered
• Estimation of period of administration
• Estimation of tolerance

The 60 patients participating in the study were divided into four groups, in accordance with the illnesses for which they were hospitalized:

• Group 1: patients with acute infections (n=25)
• Group 2: patients with chronic infections (n=15)
  • hepatitis (6)
  • hepatic cirrhosis (5)
  • chronic respiratory infections (9)
• Group 3: patients with severe infections (n=9)
• Group 4: other infections
  • HIV (8)

The product was administered in several dosages:

1. -minimal diet, 10 ml three times a day for 7 or 14 days, used in 9 patients coming from all the groups. This diet was abandoned since in the preliminary study it showed a low effectiveness in comparison with other diets.
2. -medium diet, 60 ml a day in three dosages of 20 ml three times a day for 14 days in patients with acute chronic and severe infections.
3. -maximum diet, of 50 ml two times a day in patients with infectious illnesses of the types of HIV, Herpes Zoster and severe infections.

Results:

1. Tolerance: was extremely good, no signs of sensitivity or other type of effects were shown.
2. Effectiveness:
   1. Subjective impression of the patient. All the patients declared improvement at the end of the treatment. This feeling was noted since the first 3-5 days of the treatment and persisted even after the treatment had finalized.
   2. The weight gain obtained in all the cases influenced by the dosages administered. Thus, the patients from group 4 who received 100 ml a day for 21 days gained between 2-3 Kg.
   3. Biological criteria: all patients showed improvements. In the HIV patients there were spectacular increases of CD4, between 20-300/mmc, especially in the advanced stages of the disease (the increase in values were registered in dosages of 100 ml administered for a period fo 21 days).

There were 8 HIV patients, of which only one was not receiving antiretroviral treatment. Their ages range from 17 to 57 years, with a ration per sex of three female/five male patients.

CLINIC AND LABORATORY RESEARCH OF INFLUENCE OF A PREPARATION Viusid ON HIV - INFECTED PATIENTS

State Scientific Center - Institute of Immunology of Ministry of Health of Russian Federation, Moscow
Institute of Virology named after Ivanovski, Moscow
Year 2001

Researchers:

• Simonova A.V. -DSC, leading scientist of State Scientific Institute of Immnulogy.
• Prof. Garaev M.M. – DSc, Head of biotechnological laboratory of Institute of Virology named after Ivanovski
• Smirnov B.A. – Head of Anti-AIDS Center, Odintsovo, Moscow region
• Tatanov J.A. – DSc, Head of department of preventive maintenance against AIDS, Krasnogorsk, Moscow region
• Sementsova I.G. - phthisiotherapist of 7-th Moscow Tubercular Hospital, Moscow

Treatment, preventive maintenance of HIV infection progress, the improvement of quality of life of HIV infected patients makes a serious problem for physicians and immunologists.

Now the development of new circuits of treatment of HIV infection including immunomodifiers, vitamins, antioxidants, adaptagens and food additives is conducted. The application of various alternative methods of treatment of HIV infected patients now all is more widely used in complex treatment of the given heavy disease.

In Spain, Romania, Kenya successful researches are carried out on application of a preparation Viusid (biological food supplement) in complex treatment of HIV infected patients. The positive influence of a preparation on a general condition of HIV infected patients is shown: asthenia symptoms and intoxication decreased, weight (15) was increased.

The positive changes of laboratory parameters are marked: viral loading was reduced, the content of CD4+l was increased, the blood formula was normalized after reception of Viusid in a combination with antiretroviral therapy. We carry out clinical-laboratory study of influence of a preparation Viusid at 27 HIV infected patients at a stage A and B (according to CDC classification).
The reception of a preparation was carried out under the circuit 5 grams (as a dry powder) 3 times per day within 3 months.

The majority of surveyed HIV infected patients (22 out of 27) did not accept antiretroviral therapy or other preparations, except for Viusid The received data testify the positive influence of a preparation Viusid on clinical-laboratory parameters at the majority of surveyed HIV infected patients.

According to our data the application of Viusid resulted in reduction of asthenia attributes (weakness, bad sleep, reduction of serviceability, headaches) at the observed patients. This positive action of Viusid as much as possible rendered at the end of 3 months of its application in the researches which have been carried out in Spain, the given effect is received at earlier stages of application of a preparation (15). Probably that is connected to application of Viusid in complex therapy with antiretroviral preparations. Apparently such "slowed down effect" action is connected to monotherapy of Viusid.

The reception of Viusid resulted in increase of weight at 26 out of 27 surveyed patients (at 6 patients with initially reduced weight). In this connection it is necessary to recommend reception of Viusid first of all to patients with lowered weight, to the patients with increased weight the reception of Viusid is necessary to nominate less - 1-2 times a day instead of three. The reception of Viusid results in more favorable dynamics of ARVI and influenza.

The positive effect of Viusid in complex therapy of heavy diseases of lungs (tuberculosis, pleurisy) is marked. The application of Viusid results in positive dynamics of laboratory parameters used for an estimation of tendency of HIV infection. After a course of Viusid the decrease of viral loading at 48 % of the patients is marked, at 30 % from them viral loading has decreased on 30-60 %. At 37 % of the patients the given parameter after reception of Viusid was kept at an initial level. At 15 % of the patients (4 out of 27) after a course of Viusid viral loading has increased. Those are patients actively using drugs and, in this connection, breaking reception of Viusid. The given patients had initial viral loading more than 2000 copies/ml.

Therefore to actively accepting drugs patients having high viral loading it is necessary to recommend antiretroviral therapy in complex with Viusid. The absolute content of CD4 + lymphocytes has increased after a course of Viusid at 42 % of the patients (11 men), remained within the limits of norm (with small reduction) at 42 % of the patients (11 men), has decreased at 4 patients (thus at 3 of them viral loading has decreased, at 1 - has increased).

Among the patients with small reduction of the absolute content of CD4+ lymphocytes there were 3 patients having increase of viral loading after reception of Viusid. Thus, the application of Viusid stimulates normalization of such major parameter of immunity as percentage and absolute quantity of CD4+ cells at HIV infected patients. However change of the contents of these cells does not always correlates with positive clinical dynamics of HIV infection. Therefore to estimate the efficiency of application of Viusid except for definition of the absolute contents of CD4+l it is necessary to estimate the quantity of CD8+l, dynamics of levels of leukocytes, lymphocytes, monocytes, stab neutrophile shift "to the left", RSE.

The reception of Viusid hardly influenced level of protein (at the surveyed patients it was on the top border of norm), protein fractions (the level of _-globulins was increased at the majority of surveyed patients), lipoid metabolism. At an estimation of activity of ALT, AST enzymes authentic increase of transaminase level at the surveyed patients after reception of Viusid. At 15 % of patients (4 men) the increase of the given parameters in approximately 10 and more times is marked. It could be explained by antiviral activity of Viusid that is provided by well-known antiviral effect of glycyrrhizinic acid (16) and also with the ability of Viusid to stimulate antiviral immunity. It could cause destruction of hepatitis B and C infected hepatocytes.

It was marked earlier that all investigated patients suffered from the specified forms of Hepatitis. The similar substantial growth of transaminase activity (> 1000) comes to light in a number of cases at Hepatitis virus treatment with interferon. Thus the disappearance of Hepatitis markers is marked. On the other hand, the increase of transaminase level can be connected with toxic action of Viusid on the liver cells.

To estimate the mechanism of increase of transaminase activity at reception of Viusid it is necessary to carry out additional researches of ALT and AST levels at the given patients after termination of Viusid reception. If the ALT, AST level is restored up to norm (the Hepatitis markers are kept) the observed increase of transaminase activity is determined by toxic action of Viusid on liver cells at the given patients. It is necessary to reduce a doze or to cancel a preparation to such patients. If the ALT, AST level is restored up to norm or is considerably reduced (the Hepatitis markers disappear) the observed increase of transaminase activity apparently is connected with high antiviral activity of Viusid to Hepatitis virus infected liver cells.

If the transaminase level is kept on the same high level at the given patients it is possible to assume development of a super-infection by Epshtain-Barr and CMV viruses. In this case after realization of diagnostics it is necessary to carry out antiviral therapy. Taking into account above-stated it is recommended to carry out dynamic definition of transaminase activity during reception of Viusid at HIV infected patients.

It is important to estimate the level of viral loading at HIV infected patients after termination of a Viusid course i.e. to answer a question how long the positive effect of application of Viusid is kept.

Taking into account that HIV is such a disease which accompanies the patient for the whole life it is necessary to develop the supporting course of reception of Viusid at HIV infection. Viusid preparation can be used as restorative supplement of the patients at HIV infection (early stage), and also in complex therapy (antiretroviral preparations) at various stages of HIV infection.