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Clinical Reports  
AIDS CLinical Reports
Beijing Ditan Hospital  
Initial Clinical Observations of GMA-HIV on the treatment of HIV/AIDS
           patients (5 cases)

Introduction

Beginning in January 1998, GMA-HIV has been used in the treatment of 5 patients. This is a brief report of our clinical observations.

Trial Information

Patient Selection

All patients were chosen based on a positive result on HIV antibody, and protein mark tests.

Patient Conditions

Patient

Sex

Age

Length of Condition

Diagnosis

1

Male

32

2 years

AIDS (4th Stage)

2

Male

25

0.5 years

AIDS (2nd Stage)

3

Female

32

1 year

AIDS (4th Stage)

4

Male

31

1 year

AIDS (3rd Stage)

5

Male

17

3 weeks

Acute HIV Infection


Treatment Methodology

5ml GMA-HIV Intravenous Injection Liquid mixed with 250ml of 5% Glucose solution, applied intravenously once per day for 3 days to observe for possible side-effects or drug rejection.

If no side-effects or drug rejection is observed in the patient after 3 days. Dosage is increased to 15ml GMA-HIV Intravenous Injection Liquid mixed with 250ml of 5% Glucose solution, applied intravenously once per day.

Each treatment period is 3 months.

Observation Methodology

3ml of blood serum will be taken from patients and stored, before, during, and after the treatment period. Upon the completion of the treatment period, the blood serum of the patients will be tested for HIV viral load for a comparative analysis of the effectiveness of the treatment.

Results

Changes in Clinical condition (before and after treatment)

4 out of the 5 patient have been diagnosed with AIDS with varying degree of progression. After treatment, other than the 1 patient who decided to stop the treatment voluntarily, there have been observable improvements to the conditions of the other 3 AIDS patients.

CD4 count before and after treatment

Patient

Before Treatment (CD4/mm3)

After Treatment (CD4/mm3)

 1

 40

 30

 2

 285

 510

 3

 n/a

 n/a

 4

 190

 40

 5

 n/a

 n/a


HIV viral load before and after treatment

Patient

Before Treatment (count/ml)

Month 1 (count/ml)

Month 2 (count/ml)

After Treatment (count/ml)

 1

 19000

 170000

 6300

 15000

 2

 15000

 6300

 6300

 380

 3

 7300

 3200

 3200

 3200

 4

 300000

 3700

 3700

 1100000

 5

 390000

 2600

 1800

 1800

Note:

  1. Patient 1 had undergone a 3 month treatment using AZT and ddI. The increase of viral load during the 1st month could be related to the AZT and ddI treatment.
  2. Patient 5 was also given Intron A during the treatment with GMA-HIV
Side Effects

No observable side-effects detected during this treatment

Analysis

Out of the 5 AIDS patients, improvements to clinical conditions were observed in 3 patients with varying degrees. The 4 patients using only GMA-HIV all had noticeable decrease to their HIV viral load, total effective rate is 75% (Due to Patient 5¨s combination treatment with Intron A, we did not include the patient into this statistic).

With the available data, it shows that GMA-HIV is effective in reducing the HIV viral load. For example, Patient 2 has successfully reduce the HIV viral load from 15000/ml to 380/ml after the treatment with the CD4 count raised from 285/mm-3 to 510/mm3. 2 months after stopping the treatment, Patient¨s 2 CD4 count continued to rise to 630/mm3.

Although during the treatment Patient 4¨s CD4 count was significantly lower, but Patient 4 also experienced the same situation as Patient 2, where the CD4 count went up 2 months after stopping treatment despite the fact that the patient did not undergo any further treatments. Patient 4¨s CD4 count 2 months after stopping treatment was raised from 40/mm3 to 360/mm3. The exact cause of this phenomenon is unknown.

High viral load fluctuation rates were observed during the treatment period. For example, Patient 4¨s viral load was decreased noticeably during the mid-stages of treatment but at the end of treatment was raised to extremely high levels. Patient 1 also experienced such fluctuations.

This analysis is based on initial clinical observations, at the moment we are proceeding with a 2nd treatment period.

Brief Summary

Initial observation indicates that GMA-HIV has a certain level of effectiveness and can be potentially used as a treatment for HIV/AIDS. However due to the low number of patients in this trial and short periods of observation, there is a need for longer and larger trials before any conclusive evidence can be gathered.

Beijing Ditan Hospital
Xu, Dao Zhen
Li, Xing Wang
1998 August 21