The first
assays with Naltrexone alone have been carried out in
1985-1986 by Dr. Bihari in New York (B. Bihari and al., Int.
Conf, on Aids, 1989). During a double blind test made for 38
AIDS patients for 3 months, a drastic decrease of
opportunistic infections (OI) was observed in the treated
group (no OI for 22 patients) versus 5 OI out of 16 patients
in the placebo group. At a biological level, lymphocyte
response to mitogens is decreased in the placebo group and
normal in the treated group, alpha interferon concentration
significantly decreases in the treated group but not in the
placebo group.
In 1996, a checkup carried
out for 158 patients of Dr. Bihari, ten among them being
under antiretroviral therapies, shows on the totality of the
group a stabilisation of the T4 cell count during 18 months
(from an average of 358 to 368/mm3). On this same period, it
is observed for the non-treated group a significant decrease
of T4 cell count (from 297 to 176 as a mean value).
Concerning a larger number of patients, a T4 cell count
stabilisation is observed for more than 85% of the patients.
Concerning OI and disease, 25/55 and 13/55 are respectively
observed in the non-treated group and only 8/103 and 1/103
in the treated group. In this assay, some patients were
treated for 7 or 8 years and the progression stop maintained
during all this period. Besides, no side effects were
noticed.
Various combinations of
treatment with conventional antiretrovirals have lead to
numerous assays. Associated with AZT + 3TC, we observe for
19 patients, during 18 months, a significative increase of
T4 cell count, mean value raising from 88 to 194/mm3 with
for all an increase of at least 30%. Besides, a comparative
study with AZT + 3TC, only for 68 patients, provides a very
weak increase of T4 cell count (mean value raising from 352
to 392 in 6 months). Finally, with Naltrexone, a better
standing and a weight gain (5 to 25 kg in two months
!).
Concerning another group
of 45 patients, already under AZT + 3TC + Naltrexone,
lndinavir was added (800 mg x 3/day) and Nevirapine (200 mg
x 2/day). Before this change of treatment, T4 mean cell
count was 235 (betwen 5 and 249) and mean viral load was 74
210 copies/ml. Alter one month, 42 out of the 45 patients
had an undetectable viral load which remained unchanged.
After 7 months, T4 cell mean value increased until 349 and
their percentage from 15.2 to 20.4%. A cholesterol increase
was observed (159 to 209). Clinical state improved, no OI
occured and mean weight gain was 4 kg.
The failure for 3 patients
is due to the too low Indinavir plasmatic concentration
(inferior to 8M, one hour after administration), which would
justify the commercialization of dosage kits of Indinavir to
adjust therapeutical posology.