OBJECTIVE
To test the efficiency
of glucuronamide on HIV / AIDS patients.
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METHOD
- Open trial
(1993-1996) including 23 to 35 patients.
- Analysis of the results
performed in January 96 patients. and reactualized in June
96.
- Posology: 400 mg of
glucuronamide associated to 500mg Vit.C and 50mg
caffein.
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RESULTS
- Stabilization or
improvement of the clinical state for all
patients.
- No opportunistic
infection.
- Analysis of the
biological parameters (January 1996): 23 patients (16 stage
II, 6 stage IVC1, 1 stage IVD) .
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Trial
duration: 11.3 +/- 7.5 months.
Responders: 100% of the patients.
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Parameter
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before therapy
(mean+/-sd)
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after therapy
(mean+/-sd)
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significancy:
p value
|
|
Lymphocytes / mm3
|
1995,05 +/- 454,89
|
1944,72 +/- 505,61
|
0,73
|
|
Lymph.CD4/ mm3
|
294,13 +/- 130,66
|
412,44 +/- 214,53
|
0,027
|
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CD4 Lymph.%
|
16,5 +/- 6,78
|
21,83 +/- 10,04
|
0,057
|
|
ß2 microglob mg/l
|
3,34 +/- 1,25
|
3,39 +/- 1,72
|
0,095
|
|
Triglycerides g/l
|
1,22 +/- 1,58
|
1,1 +/- 0,6
|
0,58
|
|
Antibodies anti P24 (Ab)
|
130,08 +/- 106,01
|
1965,8 +/- 106,01
|
0,021
|
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Consequences of stopping
glucuronamide: decrease of CD4 for 7 out of the 7 patients
who stopped glucuronamide therapy (for 3 to 15 months):
-52.6% (cell per mm3) and -36% (in %).
When the treatment is taken again after interruption, the
improvement of the imune parameters are no more systematic,
and when it occurs, their increase is slower with time.
- Analysis of the
CD4 variations (June 1996) : 35 patients (28 stage
II, 6 stage IVC1, 1 stage D).
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parameters
|
Before therapy (tt)
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After
therapy
|
duration
(month)
|
significativity
|
|
lymph. cd4/mm3 :
responders (n=22, 62%)
|
318,27 ± 123,09
|
455,77 ± 180,18
|
16,43 ± 9,45
|
p<0,001
|
|
non-responders
(n=13, 38%)
|
318,61 ± 155,43
|
227,54 ± 139,23
|
16,43 ± 9,45
|
p<0,2
|
|
lymph. cd4% :
responders (n=17, 73%)
|
16,29 ± 7,08
|
20,48 ± 8,53
|
19,17 ± 7,02
|
p<0,2
|
|
non-responders
(n=6, 27%)
|
18,33 ± 7,06
|
13,33 ± 5,64
|
19,17 ± 7,02
|
p<0,3
|
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CONCLUSION
Glucuronamide is a very
efficient agent in HIV+ patients, which can be used early in
infection, due to its total absence of toxicity, but can't
be stopped. For long term use of glucuronamide, the clinical
benefit persits (absence of OI) for all patients. Concerning
the CD4 counts, the benefit is maintained for the major part
of the patients. Additionnal clinical trials at different
posologies, possibly associated with other therapies, would
be of great interest. The low cost and the efficiency of
this therapy (some US cents a day) makes this therapeutical
approach an interesting choice for the third world.
This work should have important financial consequences for
Akzo-Nobel, the only glucuronamide producer for the moment
(molecule no more covered by a patent). This industrial
group has not provided any financial help to association
"Positifs" which has discovered this new therapeutic
approach of glucuronamide.
Association "Positifs" searches pharmaceutic groups to sell
the licence of its american patent on glucuronamide.
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