US20040209944A1 - Appetite stimulation and reduction of weight loss in patients suffering from symptomatic HIV infection - Google Patents
Appetite stimulation and reduction of weight loss in patients suffering from symptomatic HIV infection Download PDFInfo
- Publication number
- US20040209944A1 US20040209944A1 US10/735,017 US73501703A US2004209944A1 US 20040209944 A1 US20040209944 A1 US 20040209944A1 US 73501703 A US73501703 A US 73501703A US 2004209944 A1 US2004209944 A1 US 2004209944A1
- Authority
- US
- United States
- Prior art keywords
- tetrahydrocannabinol
- delta
- hiv infection
- patients
- reduction
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 208000031886 HIV Infections Diseases 0.000 title claims abstract description 11
- 208000037357 HIV infectious disease Diseases 0.000 title claims abstract description 11
- 208000033519 human immunodeficiency virus infectious disease Diseases 0.000 title claims abstract description 11
- 208000016261 weight loss Diseases 0.000 title description 8
- 230000004580 weight loss Effects 0.000 title description 8
- 230000007943 positive regulation of appetite Effects 0.000 title 1
- CYQFCXCEBYINGO-UHFFFAOYSA-N THC Natural products C1=C(C)CCC2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3C21 CYQFCXCEBYINGO-UHFFFAOYSA-N 0.000 claims abstract description 35
- CYQFCXCEBYINGO-IAGOWNOFSA-N delta1-THC Chemical compound C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3[C@@H]21 CYQFCXCEBYINGO-IAGOWNOFSA-N 0.000 claims abstract description 35
- XXGMIHXASFDFSM-UHFFFAOYSA-N Delta9-tetrahydrocannabinol Natural products CCCCCc1cc2OC(C)(C)C3CCC(=CC3c2c(O)c1O)C XXGMIHXASFDFSM-UHFFFAOYSA-N 0.000 claims abstract description 31
- 230000036528 appetite Effects 0.000 claims abstract description 9
- 235000019789 appetite Nutrition 0.000 claims abstract description 9
- 239000002775 capsule Substances 0.000 claims abstract description 8
- 208000020442 loss of weight Diseases 0.000 claims abstract description 5
- 208000030507 AIDS Diseases 0.000 claims abstract description 4
- 239000008159 sesame oil Substances 0.000 claims description 6
- 235000011803 sesame oil Nutrition 0.000 claims description 6
- 230000004936 stimulating effect Effects 0.000 claims description 3
- 238000002347 injection Methods 0.000 abstract description 2
- 239000007924 injection Substances 0.000 abstract description 2
- 239000000829 suppository Substances 0.000 abstract description 2
- 238000002560 therapeutic procedure Methods 0.000 description 7
- 201000011510 cancer Diseases 0.000 description 6
- 206010028980 Neoplasm Diseases 0.000 description 5
- CYQFCXCEBYINGO-DLBZAZTESA-N Dronabinol Natural products C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3[C@H]21 CYQFCXCEBYINGO-DLBZAZTESA-N 0.000 description 4
- 229960004242 dronabinol Drugs 0.000 description 4
- WIKYUJGCLQQFNW-UHFFFAOYSA-N prochlorperazine Chemical compound C1CN(C)CCN1CCCN1C2=CC(Cl)=CC=C2SC2=CC=CC=C21 WIKYUJGCLQQFNW-UHFFFAOYSA-N 0.000 description 4
- 229960003111 prochlorperazine Drugs 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 206010001513 AIDS related complex Diseases 0.000 description 2
- 230000004596 appetite loss Effects 0.000 description 2
- 238000002512 chemotherapy Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000007903 gelatin capsule Substances 0.000 description 2
- 235000021266 loss of appetite Nutrition 0.000 description 2
- 208000019017 loss of appetite Diseases 0.000 description 2
- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 description 2
- 229960002555 zidovudine Drugs 0.000 description 2
- 244000025254 Cannabis sativa Species 0.000 description 1
- 235000012766 Cannabis sativa ssp. sativa var. sativa Nutrition 0.000 description 1
- 235000012765 Cannabis sativa ssp. sativa var. spontanea Nutrition 0.000 description 1
- 208000000816 Intravenous Substance Abuse Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000003474 anti-emetic effect Effects 0.000 description 1
- 230000000840 anti-viral effect Effects 0.000 description 1
- 239000002111 antiemetic agent Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 230000000652 homosexual effect Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- RQZAXGRLVPAYTJ-GQFGMJRRSA-N megestrol acetate Chemical compound C1=C(C)C2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(C)=O)(OC(=O)C)[C@@]1(C)CC2 RQZAXGRLVPAYTJ-GQFGMJRRSA-N 0.000 description 1
- TTWJBBZEZQICBI-UHFFFAOYSA-N metoclopramide Chemical compound CCN(CC)CCNC(=O)C1=CC(Cl)=C(N)C=C1OC TTWJBBZEZQICBI-UHFFFAOYSA-N 0.000 description 1
- 229960004503 metoclopramide Drugs 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
Definitions
- 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.
- delta-9-tetrahydrocannabinol A number of cancer investigators have used delta-9-tetrahydrocannabinol 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. 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. 2 Results suggestive of an appetite stimulating effect were also noted by Ekert, et al. 3 in groups of children and adolescents 6-19 years of age administered delta-9-tetrahydrocannabinol, prochlorperazine or metaclopramide in crossover design studies.
- 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.
- 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.
- the dosage range of delta-9-tetrahydrocannabinol may vary widely from 2.5 mg to 20 mg daily, in single or divided doses.
- 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-tetrahydrocannabinol per capsule.
- delta-9-tetrahydrocannabinol can provide a significant tool in the treatment of patients with symptomatic HIV infection by improving appetite and reducing weight loss.
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.
Description
- 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.
- 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.
- A number of cancer investigators have used delta-9-tetrahydrocannabinol 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.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.2 Results suggestive of an appetite stimulating effect were also noted by Ekert, et al.3 in groups of children and adolescents 6-19 years of age administered delta-9-tetrahydrocannabinol, prochlorperazine or metaclopramide in crossover design studies.
- In a double blind study, Regelson, et al.4 observed that advanced cancer patients on chemotherapy receiving delta-9-tetrahydrocannabinol maintained their weight better than those not receiving the delta-9-tetrahydrocannabinol.
- In an open study, Wadleigh, et al.5 observed appetite increases and a lessening of the rate of weight loss in cancer patients.
- 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.
- Other objects and advantages of the present invention will be apparent from a further reading of the specification and of the appended claims.
- 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.
- 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.
- The dosage range of delta-9-tetrahydrocannabinol may vary widely from 2.5 mg to 20 mg daily, in single or divided doses.
- 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.
- 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-tetrahydrocannabinol per capsule.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Claims (12)
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.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/735,017 US20040209944A1 (en) | 1991-02-26 | 2003-12-12 | Appetite stimulation and reduction of weight loss in patients suffering from symptomatic HIV infection |
US11/537,914 US20070088077A1 (en) | 1991-02-26 | 2006-10-02 | Appetite stimulation and reduction of weight loss in patients suffering from symptomatic hiv infection |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US66151491A | 1991-02-26 | 1991-02-26 | |
US07/893,554 US6703418B2 (en) | 1991-02-26 | 1992-06-03 | Appetite stimulation and induction of weight gain in patients suffering from symptomatic HIV infection |
US10/735,017 US20040209944A1 (en) | 1991-02-26 | 2003-12-12 | Appetite stimulation and reduction of weight loss in patients suffering from symptomatic HIV infection |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/893,554 Continuation US6703418B2 (en) | 1991-02-26 | 1992-06-03 | Appetite stimulation and induction of weight gain in patients suffering from symptomatic HIV infection |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/537,914 Continuation US20070088077A1 (en) | 1991-02-26 | 2006-10-02 | Appetite stimulation and reduction of weight loss in patients suffering from symptomatic hiv infection |
Publications (1)
Publication Number | Publication Date |
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US20040209944A1 true US20040209944A1 (en) | 2004-10-21 |
Family
ID=24653916
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/893,554 Expired - Lifetime US6703418B2 (en) | 1991-02-26 | 1992-06-03 | Appetite stimulation and induction of weight gain in patients suffering from symptomatic HIV infection |
US10/735,017 Abandoned US20040209944A1 (en) | 1991-02-26 | 2003-12-12 | Appetite stimulation and reduction of weight loss in patients suffering from symptomatic HIV infection |
US11/537,914 Abandoned US20070088077A1 (en) | 1991-02-26 | 2006-10-02 | Appetite stimulation and reduction of weight loss in patients suffering from symptomatic hiv infection |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/893,554 Expired - Lifetime US6703418B2 (en) | 1991-02-26 | 1992-06-03 | Appetite stimulation and induction of weight gain in patients suffering from symptomatic HIV infection |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/537,914 Abandoned US20070088077A1 (en) | 1991-02-26 | 2006-10-02 | Appetite stimulation and reduction of weight loss in patients suffering from symptomatic hiv infection |
Country Status (1)
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US (3) | US6703418B2 (en) |
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US20090298930A1 (en) * | 2004-11-22 | 2009-12-03 | Gutman Arie L | Methods For Purifying Trans-(-) Delta9-Tetrahydrocannabinol And Trans-(+)-Delta9-Tetrahydrocannabinol |
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US20090298930A1 (en) * | 2004-11-22 | 2009-12-03 | Gutman Arie L | Methods For Purifying Trans-(-) Delta9-Tetrahydrocannabinol And Trans-(+)-Delta9-Tetrahydrocannabinol |
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US9278083B2 (en) | 2004-11-22 | 2016-03-08 | Svc Pharma Lp | Methods for purifying trans-(−)-Δ9-tetrahydrocannabinol and trans-(+)-Δ9-tetrahydrocannabinol |
US9675581B2 (en) | 2004-11-22 | 2017-06-13 | Svc Pharma Lp | Methods for purifying trans-(−)-Δ9-tetrahydrocannabinol and trans- (+)-Δ9-tetrahydrocannabinol |
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US20070072939A1 (en) * | 2005-06-16 | 2007-03-29 | Euro-Celtique, S.A. | Cannabinoid active pharmaceutical ingredient for improved dosage forms |
US20180221306A1 (en) * | 2016-10-24 | 2018-08-09 | Pellficure Pharmaceuticals, Inc. | Pharmaceutical compositions of 5-hydroxy-2-methylnaphthalene-1,4-dione |
Also Published As
Publication number | Publication date |
---|---|
US6703418B2 (en) | 2004-03-09 |
US20070088077A1 (en) | 2007-04-19 |
US20030100602A1 (en) | 2003-05-29 |
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