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:
- 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.
- 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
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