KINSHASA IMUSIL PROJECT OVERVIEW

Compassion Response Network decided in September 2003, to conduct a trial in Kinshasa of Imusil treatment on three advanced HIV/AIDS patients, with comprehensive blood testing and medical checks extending over six months after the treatment was provided.

For each patient, the treatment consisted of a single injection of Imusil. This is unusual, because most other treatments for HIV/AIDS rely upon daily or regular treatment.

Of the three patients selected, one was rejected from the trial because the bDNA blood test did not indicate HIV infection. We have a third sample of Imusil still in Kinshasa, that we will use for trialling a third patient on Imusil some time in the future, when funds permit us to continue.

Of the two advanced HIV/AIDS patients who have successfully completed the trial, one was an 18 year old boy and the other a 36 year old man. Both received their Imusil injections in May 2004. Blood tests were taken beforehand and over the next six months;

1) bDNA viral load tests indicted for both patients a doubling of HIV viral load in the blood about every two months,

2) CD4 immunity cell count remained for both patients under 200, a seriously low level of immunity causing constant risk from secondary infections.

The bDNA and CD4 results appear roughly the same as would have been expected if no treatment had been given. After four months the doctors expressed concern for the continued health of the patients.

In the first four months following receiving the injection, both patients had a period of very positive improvement in the medical checkup.Both patients showed increased vitality and a sense of returned health, while skin complexion and candidiasis cleared, and other physical symptoms of AIDS improved.

After four months however, both patients relapsed to their Pre-Imusil treatment condition of AIDS. At around four months both developed fevers. At around seven months, patient A went into a coma for nearly a fortnight, before we was revived. He remained however very weak and bed-ridden and died in March 2005, ten months after receiving the Imusil injection. With patient B, although after four months most of the AIDS symptoms have returned, his health is yet not too serious. We will continue to support him, and will offer to him an opportunity to participate in the second trial of alternative treatments to be held in Kinshasa.

Overall, the effect of the Imusil injection seemed to have been very positive over the first four months, but the positive effect seems not to have been long-lasting.

IMUSIL PROJECT BLOOD TEST RESULTS

Patient A (boy, born 9/Oct/1986, received 60% of adult dose Imusil injection 10/May/2004)

Patient B (man, born 10/Jan/1968, received full adult dose Imusil injection 6/May/2004)

bDNA Viral Load Test

Currently there are two types of viral load tests available. Both measure the HIV RNA in the blood. HIV RNA is a key to viral replication. Along with CD4 cell counts and disease symptoms, these viral load tests will help determine the health of the patient.

The bDNA test, developed by Chiron Diagnostics and marketed under the name Quantiplex® HIV-RNA, is based on direct quantification of HIV-1 RNA.

It works by binding branched DNA probes to HIV-1 RNA. This in turn binds enzymes which generates light. The amount of light is measured and is directly related to the amount of HIV-1 RNA in plasma. The bDNA technology can quantitate the major HIV subtypes found worldwide.

The polymerase chain reaction (PCR) test is produced by Hoffmann-LaRoche. This test has recently been approved by the FDA for use in determining the health status of HIV patients.

CD4 Count

CD4 is the test or marker many doctors use in determining the status of the
patient's immune system. Generally, while treating HIV clinicians use the CD4
results as an indication for commencing treatment, monitoring patients on
treatment and determining whether resistance patterns to treatment are
developing.

Full Blood Count

FBC is a Full Blood Count - This is a automated count of the 3 major
components of blood - namely -White blood cells, Red blood cells and Platelets.

White blood cells (leucocytes) help defend the body against disease. They are vital in attacking and devouring or destroying invading organisms. Without sufficient levels of white blood cells, infections would spread rapidly.

Red blood cells (erythrocytes) get their red colour from hemoglobin. They take oxygen to the tissues and remove carbon dioxide. Red blood cells are manufactured in the bone marrow, and each cell lasts about four months , after which it is destroyed and eliminated. To regularly replace red blood cells, a person requires a well balanced diet, especially foods that are rich in iron. Anemia results when the person does not replace enough red blood cells after they are destroyed or lost.

Platelets are vital in the clotting process. They help repair small blood vessels so blood does not leak out. When the skin is cut, platelets gather at the cut and help seal the vessels by clotting the blood.

Urea and Creatinine. Urea is a product in the breakdown of proteins. Creatinine results from the breakdown of creatine which is used for muscular metabolism. The result of breakdown of proteins and creatine lead to urea and creatinine passing into the blood. These are waste products, to be eliminated from the body; the blood passes through the kidneys where urea and creatinine and other waste products are filtered from the blood, to be passed into the urine which is then eliminated from the body. High levels of urea and creatinine suggest kidney malfunction and disease. Kidney failure can be an effect of advanced AIDS, and so advanced AIDS patients must therefore be regularly monitored for levels of urea and creatinine.

Liver function (hepatic) tests. Liver function can break down with advanced AIDS and viral infections, and so requires regular monitoring. The following hepatic tests have been conducted on the patients before treatment for AIDS and following 6 months of treatment;
a) bilirubin is a product of hemoglobin breakdown. It is the bile transported in blood toward the liver, and excess can cause jaundice.
b) indirect bilirubin is the bilirubin not joined to glucuronic acid (product of glucose synthesis).
c) direct bilirubin is the bilirubin joined to glucuronic acid.
d) alkaline phosphatase is an enzyme having the property to detach ionic phosphates of various organic substances. Its measurement helps to identify certain cases of hepatic illness.
e) transaminases are enzymes playing the important role in the synthesis of proteins, used especially in muscles, the brain, the liver, and the kidney.

PATIENT A CASE STUDY RESULTS

Protocol Number = CRN-KIN-2003-01
Subject Trial Identification = 0A

Demographics

Date of Birth: 9/October/1986
First and last letters of name: LL
Sex: male
Ethnic group: black
Height: 1.20 m
Weight: 35 kg
Blood type: A
Rhesus: negative

Baseline Visit: HIV/AIDS

(Examination 9/May/2004)

History

Fever
Thrush
Cough
Headache

Physical Exam

Oral Candidiasis

Etiology: p Carinii Pneumonia

Diagnosis

HIV/AIDS