U.S. patent application number 10/735017 was filed with the patent office on 2004-10-21 for appetite stimulation and reduction of weight loss in patients suffering from symptomatic hiv infection.
Invention is credited to Plasse, Terry F..
Application Number | 20040209944 10/735017 |
Document ID | / |
Family ID | 24653916 |
Filed Date | 2004-10-21 |
United States Patent
Application |
20040209944 |
Kind Code |
A1 |
Plasse, Terry F. |
October 21, 2004 |
Appetite stimulation and reduction of weight loss in patients
suffering from symptomatic HIV infection
Abstract
Patients with symptomatic HIV infection, including AIDS and ARC
are treated to increase appetite and to cause a reduction in loss
of weight. The delta-9-tetrahydrocannabinol may be administered
orally, in capsules, or in tablets, or by injection, suppository,
intranasal, transdermal, inhalant or sublingual administration.
Inventors: |
Plasse, Terry F.; (New York,
NY) |
Correspondence
Address: |
MAYER, BROWN, ROWE & MAW LLP
190 SOUTH LASALLE ST
CHICAGO
IL
60603-3441
US
|
Family ID: |
24653916 |
Appl. No.: |
10/735017 |
Filed: |
December 12, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10735017 |
Dec 12, 2003 |
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07893554 |
Jun 3, 1992 |
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6703418 |
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07893554 |
Jun 3, 1992 |
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07661514 |
Feb 26, 1991 |
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Current U.S.
Class: |
514/454 |
Current CPC
Class: |
A61K 9/4858 20130101;
A61K 31/353 20130101; A61K 31/352 20130101 |
Class at
Publication: |
514/454 |
International
Class: |
A61K 031/353 |
Claims
What is claimed is:
1. Method of treating patients with symptomatic HIV infection to
provide improved appetite and a reduction in loss of stimulating
reduction in loss of weight effective amount of
delta-9-tetrahydrocannabinol, thereby obtaining improved appetite
and a reduction in loss of weight.
2. Method according to claim 1 wherein said administration is
orally.
3. Method according to claim 1 wherein said
delta-9-tetrahydrocannabinol is administered in dosages between
about 2.5 mg to 20 mg daily in single or divided doses.
4. Method according to claim 1 wherein said
delta-9-tetrahydrocannabinol is administered in the form of
capsules containing said delta-9-tetrahydrocannabinol in sesame
oil.
5. Method according to claim 1, wherein said HIV infection is
AIDS.
6. Method according to claim 5, wherein said administration is
hrall5.
7. Method according to claim 5, wherein said
delta-9-tetrahydrocannabinol is administered in dosages between
about 2.5 mg to 20 mg daily in single or divided doses.
8. Method according to claim 5, wherein said
delta-9-tetrahydrocannabinol is administered in the form of
capsules containing said delta-9-tetrahydrocannabinol in sesame
oil.
9. Method according to claim 1, wherein said HIV infection is
ARC.
10. Method according claim 9, wherein said administration is
orally.
11. Method according claim 9, wherein said
delta-9-tetrahydrocannabinol is administered in dosages between
about 2.5 mg to 20 mg daily in single or divided doses.
12. Method according to claim 9, wherein said
delta-9-tetrahydrocannabinol is administered in the form of
capsules containing said delta-9-tetrahydrocannabinol in sesame
oil.
Description
BACKGROUND OF THE INVENTION
[0001] Among the many problems endured by patients suffering from
symptomatic HIV infection, which includes inter alia AIDS (Acquired
Immune Deficiency Syndrome) and ARC (AIDS Related Complex), are
loss of appetite with consequent loss of weight. This loss of
appetite and loss of weight further debilitates the patients and
increases the many problems associated with the HIV infection.
[0002] The compound delta-9-tetrahydrocannabinol, which is the
active ingredient in marijuana and which was produced chemically as
described in Pat. No. 3,668,224, has been used as an antiemetic to
relieve nausea and vomiting in patients receiving cancer
chemotherapy.
[0003] A number of cancer investigators have used
delta-9-tetrahydrocannab- inol to attempt to increase appetite and
modify weight loss in cancer patients. For example, in a randomized
double-blind crossover study employing oral
delta-9-tetrahydrocannabinol and prochlorperazine, 50% of the
subjects on delta-9-tetrahydrocannabinol reported an increased food
intake while only 29% had a similar response on the
prochlorperazine..sup.1 In another study of similar design and
using the same medications, patients on
delta-9-tetrahydrocannabinol reported feeling more hungry than
patients on prochlorperazine..sup.2 Results suggestive of an
appetite stimulating effect were also noted by Ekert, et al..sup.3
in groups of children and adolescents 6-19 years of age
administered delta-9-tetrahydrocannabinol, prochlorperazine or
metaclopramide in crossover design studies. .sup.1 Sallan, S E;
Cronin, C; Zelan, M; and Zinberg, N E (Sidney Farber Cancer
Institute, Boston, Mass.): Antiemetics in patients receiveing
chemotherapy for cancer. A prochlorperazine. N. Engl. J. Med.
301:135-138 (Jan. 17) 1980, No. 3. .sup.2 Ungerleider, J T;
Andrysiak, T; Fairbanks, L; Gooodnight, J; Sarna, G; and Jamison,
K. (UCLA Center for the Health Sciences, Los Angeles, Calif.):
Cannabis and cancer chemotherapy. A comparison of oral delta-9-THC
and prochlorperazine. Cancer 50:636-645 (Aug. 15) 1982, No. 4.
.sup.3 Ekert, H; Waters, K D; Jurk, I H; Mobilia, J; and Loughnan,
P. (Royal Children's Hospital, Melbourne, Australia): Amerlioration
of cancer chemotherapy-induced nausea and vomiting by
delta-9-tetrahydrocannabinol. Med. J. Aust. 2:657-659 (Dec. 15)
1979.
[0004] In a double blind study, Regelson, et al..sup.4 observed
that advanced cancer patients on chemotherapy receiving
delta-9-tetrahydrocannabinol maintained their weight better than
those not receiving the delta-9-tetrahydrocannabinol. .sup.4
Regelson W, Butter J R; Schultz J; Kirk T; Peek L; Green M L;
Delta-9-tetrahydrocannabinol, (delta-9-THC) as an effective
antidepressant and appetite-stimulating agent in advanced cancer
patients. The pharmacology of marihuana, (Braude M C & Szara S
eds) Raven Press, N.Y. (1976; pp. 763-766.
[0005] In an open study, Wadleigh, et al..sup.5 observed appetite
increases and a lessening of the rate of weight loss in cancer
patients. .sup.5 Wadleigh, R; Spaulding, M; Lembersky, B; Zimmer.
M: Shepard, K; Plasse, T; Dronabinol enhancement of appetite in
cancer patients. Proceedings 1990 American Cancer Society of
Clinical Mycology Meeting.
SUMMARY OF THE INVENTION
[0006] It is accordingly a primary object of the present invention
to provide for the treatment of patients suffering from symptomatic
HIV infection so as to improve the appetite and reduce weight loss
in such patients.
[0007] Other objects and advantages of the present invention will
be apparent from a further reading of the specification and of the
appended claims.
[0008] With the above and other objects in view, the present
invention mainly comprises the administration to a patient
suffering from symptomatic HIV infection of an appetite stimulating
effective amount of delta-9-tetrahydrocannabinol.
[0009] The delta-9-tetrahydrocannabinol is preferably administered
orally as dronabinol (delta-9-tetrahydrocannabinol in sesame
oil-containing capsules). Administration is also possible to
achieve the effects of the present invention when the
delta-9-tetrahydrocannabinol is in the form of tablets,
suppositories, intranasal administration, transdermal
administration, inhalants and sublingual administration, as well as
administration by injection.
[0010] The dosage range of delta-9-tetrahydrocannabinol may vary
widely from 2.5 mg to 20 mg daily, in single or divided doses.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0011] The following is given to further illustrate the present
invention. The scope of the invention is not, however, meant to be
limited to the specific details thereof.
EXAMPLE I
[0012] Soft gelatin capsules were filled with
delta-9-tetrahydrocannabinol in sesame oil (dronabinol). Capsules
were filled with 2.5 mg delta-9-tetrahydrocannabinol per capsule or
5 mg delta-9-tetrahydrocannab- inol per capsule.
[0013] Ten symptomatic HIV patients were treated with
delta-9-tetrahydrocannabinol. The patients studied were all
homosexual males; one had a history of intravenous drug abuse as
well. The infectious complications which they had represent the
spectrum of those usually seen in a symptomatic HIV-infected
population.
[0014] Most of the patients had received or were on antiviral
therapy, primarily zidovudine (azidothymidine). Two had previously
received and one was receiving megesterol acetate as well. Patients
received delta-9-tetrahydrocannabinol as dronabinol
(delta-9-tetrahydrocannabinol in sesame oil in soft gelatin
capsules), usually at a dose of 2.5 mg, for one to five months.
Treatment continued for most of the patients at the time of this
analysis. The dose varied. The patients were instructed to take
medication up to four times daily as needed; many took it somewhat
less often.
[0015] Initially, patients were losing a median of 0.93 kg/mo. On
therapy, they gained 0.54 kg/mo. The median difference on versus
pre-therapy was 1.92 kg/mo. Seven patients gained weight while two
others had a decrease in weight loss. This result was unexpected as
previous studies in cancer patients showed that while weight loss
lessened, patients rarely gained weight.
EXAMPLE II
[0016] In a prospective, dose-ranging study, 23 patients with
symptomatic HIV infection were treated with dronabinol at a dose of
2.5 mg twice daily to 5.0 mg three times daily. Of these, 13
completed approximately one month on therapy. Of those completing
one month on therapy, seven gained weight.
[0017] At a dose which appears optimal, seven of eight patients
completed one month treatment. At that dose, most patients did not
experience side effects. Most of those patients who did experience
side effects found them tolerable. Confirming the unexpected
results of Example I, five of the seven patients gained weight. The
median rate of weight loss prior to therapy was 1.62 kg/mo; on
therapy, the median weight gain was 1.56 kg/mo. The median
improvement in the rate of weight change was 3.06 kg/mo, or
approximately 1.5 lbs/wk.
[0018] It thus appears that delta-9-tetrahydrocannabinol can
provide a significant tool in the treatment of patients with
symptomatic HIV infection by improving appetite and reducing weight
loss.
[0019] While the invention has been illustrated with respect to
specific dosages, it is apparent that variations and modifications
can be made without departing from the spirit or scope of the
invention.
* * * * *