1st IKA HOSPITAL
2nd Department of Internal Medicine and AIDS Unit
Director : Dr George D.Stergiou
4 Zaimi str., Melissia, Athens, GREECE, 15127
Tel-fax: (301) - 8042474

Athens 27-12-95

Dear Prof. Saxena,

We really appreciate your concern and interest in the PAP-IMI-300 ion magnetic device as well as in its application to our HIV infected patients.

In accordance with our previous communication, we are sending you all the available data concerning these patients.

We present the main characteristics, clinical status and evolution of our patients, on whom the PAP -IMI -300 device was applied.

Patient No. 1

Name initials : AG/KY Code number : 199
Male, 32 years old, homosexual, HIV seropositive since 4-93.

Kaposi's sarcoma lesions in his arms and left leg since 6-94. Started zidovudine (ZDV) and interferon-A-2b in 8-94. Lesions worsened and PAP-IMI-300 treatments were applied in 2-95. Interferon administration was then stopped but antiretroviral treatment was continued. Following the PAP-IMI-300 application, the patient's skin lesions remained stable and have continued to remain stable up to now (12-95). The patient feels better and stronger and he has gained weight. Consecutive CD4 counts (per mm³ ) were : 360 (8-94), 266 (1-95), 455 (4-95), 576 (6 -95), 558 (10-95). Blood count and biochemical values remained stable.

Patient No. 2

Name initials: IO/GE Code number : 99
Female, 32 years old, heterosexual, HIV seropositive since 9-89.

Herpes Zoster of right leg (12-89), hairy leucoplakia (3-90), oral thrush (2-94), Kaposi's sarcoma lesions in her gums and palate (6-94). Interferon - A - 2b was administered concomitantly with antiretroviral therapy, which was begun in 3-90 ( ZDV, DDI , DDC ). She was also receiving aerosolized pentamidine ( allergic to cotrimoxazole ). On February 1995 she refused to take interferon any longer.

PAP-IMI-300 treatments were begun in February and applied for three months. During interferon treatment and PAP-IMI-300 application, the oral lesions remained stable. Her CD4 counts (cells/mm³) were 187 (6-94), 60 (12-94) 235 (end of March 1995). But her compliance to the treatment regimen was rather poor. After three months we lost touch with her as she failed to continue her treatments. After a few months we learned that she was being followed up in another AIDS unit, where she had presented pulmonary tuberculosis and brain infarcts. Her CD4 count had dropped below 50 cells/mm³. In the absence of PAP IMI treatments CD4 count is observed always to fall and never to spontaneously rise. So, although a CD4 count was not taken immediately prior to the commencement of PAP IMI treatments in 2-95, it can be assumed that the CD4 count at that time was below 60, and not above.

Patient No. 3

Name initials : MI/GE Code number : 261
Male, 59 years old, homosexual, HIV seropositive since 2-94.

Adenocarcinoma of sigmoid colon (6-93). Left semicolectomy ( stage C2, Ashler-Coller ). Metastatic lesion in the liver (1-94). After the documentation of HIV-1 seropositivity, he is followed up in our department. He then received chemotherapy (5-FU plus leucovorin), antiretroviral therapy and interferon -A-2b. On May 1995 PAP-IMI-300 treatments were applied due to constant pain in the right upper quadrant of his abdomen. Pain was significantly relieved and his general condition was improved. This analgesic effect lasted for several weeks. Subsequently, his compliance to treatment was not very good. Up to now he has shown no AIDS defining illness but other metastatic lesions appeared in the liver and lumbar spine. CD4 counts (cells /mm³) : 212 (2-94), 40 (10-94), 284 (6-95). Although a CD4 count was not taken immediately prior to the commencement of PAP IMI treatments in 5-95, it can be assumed that the CD4 count at that time was below 40, and not above (see Case 3).

Patient No. 4

Name initials : PA/ NI Code number : 281
Male, 31 years old , bisexual, HIV seropositive since 1989.

Kaposi's sarcoma lesions in skin and lung. PAP-IMI-300 treatments were applied only 5 times (7-95). His clinical situation worsened rapidly and the patient died one month later. No comparable CD4 counts are available.

Patient No. 5

Name initials : KA/EV Code number : 151
Male, 35 years old, homosexual, HIV seropositive since 1-90.

He has shown no AIDS defining illness. Antiretroviral treatment since 11-93 ( ZDV, DDI, DDC). PAP-IMI-300 treatments were applied in 7-95. 3TC plus ZDV were begun in 9-95. CD4 counts (cells/mm³): 215 (5-94), 156 (7-94), 154 (11-94), 138 (2-95), 128 (5-95), 119 (8-95), 378 (11-95). He is still being treated with the PAP-IMI-300 and in excellent condition.

Patient No. 6

Name initials : SE/MA Code number : 131
Male, 32 years old, homosexual, HIV seropositive since 1988.

PCP (10-90). Oral thrush (1-93). Oral herpes simplex infection (10-93). Hairy leukoplakia (2-95). Antiretroviral treatment and PCP prophylaxis since 10-90. From April 1995 he reported intermittent fever. PAP-IMI-300 treatments were applied on 7-95. His general condition improved. Fever kept recurring to a lesser degree. 3TC plus ZDV begun on 9-95. Now he is in almost excellent condition and is still on the PAP-IMI-300. CD4 counts (cells/mm³): 11 (1-95), 6 (4-95), 12 (7-95), 5 (9-95), 4 (10-95).

Patient No. 7

Name initials : VA/ IO Code number : 260
Male, 34 years old, bisexual, HIV seropositive since 1988.

PCP (9-94). CMV retinitis (10-95). Antiretroviral therapy since 2-94 (AZT, DDI, 3TC plus ZDV). PAP-IMI-300 treatments were applied on 7-95 (only a few applications). No comparable results have been forthcoming.

Patient No. 8

Name initials : PS/PO Code number : 259
Male, 29 years old, homosexual, HIV seropositive since 1988.

Oral thrush (4-95). No AIDS defining illness. Antiretroviral therapy since 2-94 (ZDV, DDI, DDC). PAP-IMI-300 treatments were applied on 7-95. He remains in good condition. He began 3TC+ZDV on 9-95. CD4 counts (cells/mm³) : 63 (3-95), 55 (9-95), 56 (10-95).

Patient No. 9

Name initials : PA/KO Code number : 28
Male, 49 years old, bisexual, HIV seropositive since 5-85.

Oral herpes simplex infection (7-94). Oral thrush (2-95). Anti-HCV (+) since 2-95. Antiretroviral treatment since 2-89 (ZDV, DDI, DDC). PAP-IMI-300 treatments were applied on 7-95. He remains in a rather good and stable condition. CD4 counts (cells/mm³): 7 (11-94), 2 (6-95), 3 (10-95).

Patient No. 10

Name initials : CH/KO Code number : 305
Male, 50 years old, homosexual, HIV seropositive since 5-95.

Interstitial pneumonia resolved with cotrimoxazole (6-95). Oral thrush (6-95). Intestinal cryptosporidiasis (6-95). Kaposi's sarcoma in nose and left malar area (7-95). Treatments with the PAP-IMI-300 were applied (7-95) and interferon -A -2b was administered (7-95). Lesions remained stable. Antiretroviral treatment since 6-95 (ZDV). CD4 counts (cells/mm³): 190 (6-95), 60 (9-95).

Patient No. 11

Name initials : KA/IO Code number: 212
Male, 29 years old, bisexual, HIV seropositive since 3-92.

Antiretroviral treatment since 2-95 (ZDV). Varicella (6-95). Treatments with the PAP-IMI-300 were applied on 10-95. He remains in very good condition. CD4 counts (cells/mm³) : 296 (2-95), 342 (5-95), 356 (9-95), 303 (12-95). Viral load measurements are pending.

Patient No. 12

Name initials : KA/MA Code number : 255
Female, 26 years old, heterosexual, HIV seropositive since 2-92. Wife of patient No 11.

Antiretroviral treatment since 3-94. Varicella (6-95). Treatment with the PAP-IMI-300 was applied on 10-95. She is in excellent condition. CD4 counts (cells/mm³): 440 (3-94), 578 (9-94), 488 (5-95), 463 (9-95), 415 (12-95). Viral load measurements are pending.

In conclusion, in four of our patients we noticed an improvement of their clinical condition, in 6 their condition remained stable, while one patient showed a worsening. The Kaposi's sarcoma lesions remained at least stable during the application period.

An increase of CD4 count was demonstrated in four of our patients. The increase was quite remarkable in some of them. In three, the CD4 count remained rather stable while there was a worsening in three of them. The study was approved by the Greek National Drug Organization.

All patients have signed an informed consent. It is also noteworthy that they have experienced no side effects or adverse reactions during or after the PAP-IMI-300 application. We must also note that all patients were receiving antiretroviral treatment as well all the appropriate prophylactic regimens.

This data are obviously preliminary but encouraging. We don't know why some patients showed such an increase in their CD4 count. Further study is needed. The extent and duration of the device's effect must be assessed. Viral load and other immunological measurements are needed. In two of our patients such measurements are in progress.

We are looking forward to having a fruitful collaboration with you concerning the PAP-IMI-300 device and perhaps in other topics as well. We would be happy to participate in a common protocol in the future. Your thoughts and experience will be valuable to us.

Dr. Anthony Papadopoulos, Dr. John Arkadianos and Dr. Anthony Scoullos are actively working on this study.

Sincerely yours
George D. Stergiou, MD

Patient 1

Patient 2

Patient 3

Patient 5

Patient 6

Patient 7

Patient 8

Patient 9

Patient 10

Patient 11

Patient 12