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FINAL REPORT
Introduction
The rapidly increasing number of HIV-infected subjects1 and the restricted
number of anti retrovirals to advanced disease2 makes the search
for alternate solutions imperative. Among the alternate solutions
are drugs which could booster the immune System'. Aurea Cento 100
is one of the drugs which have been proposed to this effect4. We thus
evaluated the effects of Aurea Cento 100 in HIV infected subjects
with CD4 counts greater than 250/mm^3 in Cameroon.
(in this report /mm)
Methods, study design and subjects
We undertook a double-blind placebo-controlled trial that compared
Aurea Cento 100 to placebo on HIV infected persons with CD4 cell counts
greater than 250/mm^3. The study lasted from February 2002 to 5eptember
2002. We recruited sixty HIV infected persons (30 on Aurea cento and
30 on control). The drugs and placebo were provided by the The Welu
Enterprise, Cameroon, with disclosure of drug and placebo identity
only at the end of the trial.
All subjects presented a complete past medical history and underwent
a thorough physical examination as well as an initial biological evaluation
(full blood count, blood chemistry - urea, creatinine, bilirubin;
CM and viral load). Aurea Cento 100 or placebo were freely and blindly
distributed to subjects according to a table of randomly prepared
numbers on the bottle containers. The dose was 10 drops, three times
a day for three months, at least 10 minutes away from meals. Based
on previous reports, use of other drugs such as antibiotics, vitamins,
tronquilisers etc was not prohibited4.
The subjects were monitored clinically every month and whenever they
presented themselves for medical assistance. At the end of three months
all subjects were re-evaluated biologically. Subjects who were lost
to follow-up, or who eventually begun antiretroviral therapy were
dropped from the study.
Data recording and analysis
All data were recorded on pre-prepared medical forms for post
medical history, complaints, physical examination and laboratory findings
The computer program EPI Info 6.2 of the CDC and WHO, was used to
analyze the data. The basal characteristics of the subjects on placebo
and Aurea were compared. The mean variation in biological values was
used to evaluate the effect of drug or placebo.
Results
Baseline characteristics:
Thirty-five of the sixty subjects recruited were succesively followed-up
for 3 consecutive months. Twenty were on Aurea while 15 (42.9%) were
on placebo. Twenty-five (71.4%) of subjects were female. Their ages
ranged from 20 to 52 years with a mean of 31 years. The baseline characteristics
of the subjects were well balanced between the two groups.
Changes in markers of HIV infection
After 3 months of monitoring, the changes in CD4 counts in subjects
on Aurea varied from an increase of 119 cells/mm^3 to a decrease of
56 cells/mm^3, while in subjects on placebo this varied from an increase
of 36 cells/mm^3 to a decrease of 201 cells/mm3. The mean variation
of CD4 counts in patients on Aurea (+23 cells/mm^3) was significantly
different from that of those on placebo (- 29cells/mm^3).
The mean variation in viral load was +9792 RNA copies/ml in subjects
on AUREA as against -17461 RNA copies/ml in the control group (p=
0.03).
Other effects of treatment
During the follow-up period very few subjects had new complaints.
Intestinal discomfort, cough, catarrh were sporadically mentioned indifferently
in both groups but these subsided spontaneously.
The biological indicators of liver, renal and bone morrow function evaluated
remained within normal limits and thevariations were not statistically
different between the two groups.
Discussion
This study suggests that Aurea increases the CD4 counts of subjects
receiving it at the dose of 10 drops thrice a day. This is in line
with the claims of the manufacturer who proposes it as on immune booster
4. We evaluated the patients after 3 months of Aurea, which is reported
as the east time needed for changes to be noted. Greater and clinically
important changes in 04 counts could be observed if it is taken far
a longer period. Aurea could thus be proposed to HIV-infected patients
with Cb4 counts greater than 250/mm3 as an immune booster. It could
also be of clinical use in other diseases associated to immune depression,
like measles- It however needs to be evaluated to this effect.
Although the viral load variation was on increase of 9792 RNA copies/ml
in subjects on Aurea as against a decrease in subjects on placebo,
these variations are very finite when compared to the mean initial
viral loads which were in the order of 10^6 RNA copies/ml. This however
indicates the limited immune booster effects of Aurea with no effects
on the viral toad. Subjects on Aurea will thus need to be followed-up
with determination of viral loads which might increase and necessitate
the use of antiretrovirals.
Followup note- Neither the clinical nor biological monitoring suggested
any side effects associated to the use of Aurea. Long-term follow
up of the drug is needed once the drug goes to general use.
End of Study Report from Dr. Peter Ndumbe and staff - University Hospital
in Cameroon
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