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1. In the first organized pilot study of DNCB
involving 16 HIV-infected patients 10, the
results were as follows: DNCB application on a weekly basis
resulted in increased numbers of cytotoxic CD8+ effector T-cells and natural killer cells
in patients at various stages of HIV disease. Other studies had shown that elevated CD8+
effector T-cells and natural killer cells are important in prognosticating survival in HIV
disease 11,12.
- No patients had progression of their disease.
- Two patients had excessive skin reactions to DNCB. Those reactions
were easily treated with topical creams.
2. The following was observed in a study of 24
patients with early-stage HIV disease sensitized with DNCB 13.
- Treatment with DNCB elevated cytotoxic CD8 + effector and natural
killer cell levels.
- There were significant decreases in viral load for patients treated
with DNCB whose viral load before treatment was greater than 10,000 copies per ml. There
were no changes in viral load for patients whose viral load before treatment was less than
10,000 copies per ml.
- Toxic skin reactions to DNCB were not seen.
3. There was a follow-up study - 21 of the 24
patients described above (all of whom had been treated with DNCB). Eleven had discontinued
treatment after nearly a year. The remainder had continued DNCB treatment until the end of
the study, over a year later. The results were as follows:
- There were significant increases in CD8 + effector and natural killer
cells in patients who continued treatment and significant decreases in those who had
discontinued treatment.
- There were superior clinical outcomes for the 13 patients who
continued treatment (two developed AIDS and none died), as compared with the 11 patients
who discontinued treatment (five developed AIDS and four died).
4. In addition to these pilot studies, it is
important to note that for well over ten years thousands of patients with HIV disease have
been using DNCB on a self-prescribed basis 8.
Physicians in contact with many of those users, including those with extensive HIV/AIDS
experience, report the following:
- Survival rates, opportunistic infection rates and general health
appear to have been considerably better in DNCB-treated patients than in untreated
patients. Many say that these rates have also been better than for patients treated with
antiretroviral therapy.
- There are no reports of adverse effects with use of the standard
dosage. In summary, DNCB applications have been well-tolerated 8.
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1. The following results were reported from a controlled clinical DNCB
trial in Brazil 14, without any significant
adverse effects being noted:
- Patients treated with DNCB gained significant amounts of weight,
while untreated patients lost significant amounts of weight.
- Treated patients had significantly higher CD4 and CD8 + effector T
cell counts than did control patients.
- Only 4% of treated patients progressed to AIDS, while 40% of control
patients progressed.
- All of the untreated patients had infectious complications during the
trial. Only 21% of the control patients had those complications.
2. The effect of DNCB on viral load has also been
the subject of a controlled clinical trial 15.
Eight patients were treated with DNCB and six were untreated. The trial lasted three to
four months. The results were as follows:
- During the short period of the trial, the mean CD4 and CD8 + effector
T-cell levels increased in the treated group and decreased in the untreated group, but the
changes were not statistically significant.
- There was a significant decrease in the mean plasma viral load of the
treated group and significant increase in the mean viral load of the untreated group.
3. There has been a controlled clinical trial of
the effect of DNCB in monkeys at the Karolinska Mediko-Kirurgiska Institut in Stockholm
[in press]. The monkeys were infected with simian immunodeficiency virus (SIV). A group of
nine cynomolgus macaque monkeys was infected with SIV. Five were treated with DNCB and
four were not. The results were as follows:
- All monkeys appeared healthy for 12 months.
- By 16 months, all the monkeys treated with DNCB remained healthy, but
three of the four untreated monkeys died of lymphoma.
4. Additional controlled clinical trials are
underway.
Controlled clinical trials of DNCB are underway at two locations in the USA. One is in
Honolulu, Hawaii, where L. Bruce Mills, M.D., of the University of Hawaii is the Principal
Investigator 16. It was Dr. Mills who, over
twelve years ago, first examined the use of DNCB in HIV patients after working with the
compound at Stanford University 9. Dr. Mills'
trial is being carried out under an Investigational New Drug Application (IND) of the U.S.
Food and Drug Administration (FDA). The purpose of the clinical trial in Honolulu is to
evaluate the efficacy of delivering DNCB by a skin patch, rather than by applying it to
the skin in an acetone solution.
The second clinical trial of DNCB is nearing completion at the University of Texas
Southwestern Medical Center at Dallas 17. The
Principal Investigator there is Ponciano D. Cruz, Jr., M.D. That trial has been funded by
a grant from the U.S. National Institutes of Health (NIH). The clinical trial in Dallas
resulted from the belief that inexpensive dermatologic intervention with DNCB may have a
positive influence on morbidity and mortality in HIV disease.
The clinical trial in Dallas was designed to analyze the combined effect of DNCB and
antiretroviral therapy on patients with HIV disease, and to investigate the relationship
between HIV infection, skin diseases, and therapeutic interventions.
Preliminary indications are that
there have been significant benefits from the addition of treatment with DNCB in patients
already being treated with antiretroviral therapy.
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