JPH06502846A - Pharmaceutical composition comprising CD4 and anti-HIV polyanion agent and method for using the same - Google Patents
Pharmaceutical composition comprising CD4 and anti-HIV polyanion agent and method for using the sameInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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Abstract
(57)【要約】本公報は電子出願前の出願データであるため要約のデータは記録されません。 (57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.
Description
【発明の詳細な説明】 CD4及び抗HIVポリアニオン剤からなる薬剤組成体及びその利用方法 本発明は、薬物の速効のある組成体及び、ヒト免疫不全ウィルス(HI V)及 び関連ウィルスに対する薬剤の利用方法に関する。[Detailed description of the invention] Pharmaceutical composition comprising CD4 and anti-HIV polyanion agent and method for using the same The present invention provides fast-acting compositions of drugs and drugs for human immunodeficiency virus (HIV) and and how to use drugs against related viruses.
HIVの感染サイクルは、多くの段階を含み、それらの各段階に、感染を防止す る化学療法を施すことが可能である。感染サイクルの第1の段階は、HIVウィ ルスの宿主細胞への吸着である。ウィルスの主な受容体は、CD4と呼ばれる細 胞表面の糖タンパク質であると考えられており、それはT黴すンパ球及びマクロ ファージ内に存在する。従って、ウィルスのCD4に対する吸着を阻止できる薬 剤を特定することに多くの注意が払われてきた。The HIV infection cycle involves many steps, each of which includes steps to prevent infection. Chemotherapy can be administered. The first stage of the infection cycle is the HIV virus. This is the adsorption of Rus to host cells. The main receptor for viruses is a cell called CD4. It is thought to be a glycoprotein on the surface of T. mold cells and macrophages. Present within phages. Therefore, drugs that can block the adsorption of viruses to CD4 Much attention has been paid to identifying agents.
HIVウィルスは、CD4とウィルスの表面糖タンパク質、gp120との間の 相互作用によって、CD4へ吸着すると考えられている。遺伝子工学によって作 られた可溶性組み替えCD4 (s rCD4)が、細胞CD4にHIVウ−イ ルスが吸着することを阻止できることが発見さね、従って、試験管内のHIVの 感染を防止できる。従って、HIVの感染は、s rCD4の投与によって防止 できることが明らかにされた。CD4−IgFcイミューノアドヘシン(imm unoadhesins)、CD4 Vl−V2ドメイン、及びCD4誘導ペプ チドという、gp120と結合可能な、他のCD4類似物質もまた、抗HIV剤 として提案されてきた。しかしながら、HIVウィルスが、細胞に結合すること を防止することに関するCD4やCD4類似物質の性能は、今までのところ期待 に答えるような物ではなく、望まれるよりも高濃度の薬剤が必要である。The HIV virus has a link between CD4 and the viral surface glycoprotein, gp120. It is thought that it adsorbs to CD4 through interaction. Created by genetic engineering The obtained soluble recombinant CD4 (srCD4) is transferred to cellular CD4 by HIV virus. It has been discovered that the virus can be prevented from adsorbing to HIV in vitro. Can prevent infection. Therefore, HIV infection can be prevented by administration of srCD4. It has become clear that it is possible. CD4-IgFc immunoadhesin (imm unoadhesins), CD4 Vl-V2 domain, and CD4-induced peptide Another CD4 analog that can bind to gp120, Tide, is also an anti-HIV agent. has been proposed as. However, the ability of the HIV virus to bind to cells The performance of CD4 and CD4 analogs in preventing , and higher concentrations of the drug than desired are required.
ウィルスが細胞に吸着することを阻止する、他の抗HIV剤としては、エバンス ブルー(Evans Blue)、アラリントリカルボン酸(ATA)、スラミ ン(suramin)、及びある種の硫酸で処理された多糖類を含む、多くのポ リアニオン化合物がある。もし、CD4と、そのような抗HIVポリアニオン剤 か同時に使用されたならば、総合的な抗HIV作用は、それらを個々に用いた場 合の作用の合計よりも良いと考えられてきた。Other anti-HIV drugs that prevent the virus from adsorbing to cells include Evans Blue (Evans Blue), alarintricarboxylic acid (ATA), Surami Many polymers, including suramin, and certain sulfuric acid-treated polysaccharides, There are lianion compounds. If CD4 and such anti-HIV polyanion agents or when used simultaneously, the overall anti-HIV effect is greater than when they are used individually. has been thought to be better than the sum of their effects.
しかしながら、本発明者は、CD4(特に指定した場合を除き、これ以降は、C D4とCD4類似物質との両方を含む。)と硫酸で処理された多糖類のような抗 HIVポリアニオン剤とを同時に用いた場合、それらは、抗ウィルス作用を単に 合計した場合よりも、HIV感染に対してより効果的であることを発見した。However, the inventor does not agree that CD4 (hereinafter referred to as CD4 unless otherwise specified) Contains both D4 and CD4 analogs. ) and polysaccharides treated with sulfuric acid. When used concomitantly with HIV polyanionic agents, they only have antiviral action. They found that they were more effective against HIV infection than in total.
従って、本発明は、CD4またはCD4類似物質、及び抗HI Vポリアニオン 剤からなる、−回分の投薬量の、HIV及び関連ウィルスに対する薬剤を提供し 、その薬剤中のCD4またはCD4類似物質の量は、CD4またはCD4類似物 質のみか含まれているときのウィルス抑制に有効な量よりも少ない。Therefore, the present invention provides CD4 or CD4 analogues, and anti-HIV polyanions. medicament against HIV and related viruses in dosages consisting of - , the amount of CD4 or CD4 analog in the drug is When only the quality is contained is less than the amount effective in suppressing the virus.
本発明に基づく薬剤は、CD4のみの、即ち抗HIVポリアニオン剤を含まない 場合の、CD4の抗ウィルスの有効服用量に比べて、少ないCD4を含むことに なる。CD4のみが使用されるときと等しい抗ウイルス効果を得るために必要な CD4の量の減少分は、おそらく、必要なCD4の量の1/10未満(または、 より好ましくは、1/100未満)であろう。従って、本発明は、以前に実行可 能であった量よりも、減少された、従ってより安全でより経済的な量の抗HIV 剤の組成体としてのCD4の利用の可能性を提供する。The medicament according to the invention is CD4 only, i.e. does not contain anti-HIV polyanion agents. Containing less CD4 compared to the effective dose of CD4 antiviral Become. necessary to obtain an antiviral effect equal to that when CD4 alone is used. The reduction in the amount of CD4 is probably less than 1/10 of the amount of CD4 needed (or More preferably, it is less than 1/100). Therefore, the present invention a reduced and therefore safer and more economical amount of anti-HIV than was previously possible. The present invention provides the possibility of using CD4 as a pharmaceutical composition.
本発明に基づく薬剤はまた、正規な有効な服用量よりも少ない服用量のポリアニ オン化合物を含んでも良い。既知の多(の抗HIVポリアニオン剤が非常に有毒 なので、ポリアニオン化合物を減少できることは利益である。例えば、硫酸で処 理された多糖類は、抗凝固作用を有する。抗HIVポリアニオン剤が、硫酸で処 理された多糖類からなるとき、それは、本発明の組成体内に、硫酸で処理された 多糖類のみを含む抗HIV剤に必要とされるよりも少ない量で存在することにな る。The medicament according to the invention may also be used to treat polyaniline at lower doses than the normal effective dose. ion compounds may also be included. Several known anti-HIV polyanionic agents are highly toxic. Therefore, it is an advantage to be able to reduce polyanionic compounds. For example, treated with sulfuric acid The processed polysaccharides have an anticoagulant effect. Anti-HIV polyanion agent treated with sulfuric acid When the polysaccharide is treated with sulfuric acid, it is It will be present in lower amounts than required for anti-HIV drugs containing only polysaccharides. Ru.
結果的に、硫酸で処理された多糖類を含む本発明の組成体は、既知の硫酸で処理 された多糖類よりも、少ない含有量の硫酸で処理された多糖類を原因とする、低 いレベルの抗凝固作用を有することになる。Consequently, compositions of the invention comprising sulfuric acid-treated polysaccharides can be prepared using known sulfuric acid-treated polysaccharides. due to the lower content of sulfuric acid-treated polysaccharides than the treated polysaccharides. It has a high level of anticoagulant effect.
本発明で用いられる、抗HIVポリアニオン剤は、好ましくは、硫酸で処理され た多糖類を含む。これは、例えば、デキストラン硫酸、ベント酸多糖類、ツーコ イダン(fuc。The anti-HIV polyanionic agent used in the present invention is preferably treated with sulfuric acid. Contains polysaccharides. This includes, for example, dextran sulfate, bento acid polysaccharide, Idan (fuc.
1dan)、及びデキストリン硫酸を含む。抗HIV作用を有する他の硫酸で処 理された多糖類(例えば、欧州特許第240.098号及び第293,826号 明細書を参照のこと。)が用いられても良い。好ましくは、硫酸で処理された多 糖類は、単糖類ユニットあたりに、少なくとも1つの硫酸塩グループを含む。1dan), and dextrin sulfate. Treatment with other sulfuric acids that have anti-HIV effects processed polysaccharides (e.g. EP 240,098 and 293,826) See specification. ) may be used. Preferably, the polyester treated with sulfuric acid Sugars contain at least one sulfate group per monosaccharide unit.
治療に用いる場合、本発明の抗HIV剤は、腸内に(経口によることを含む)ま たは非経口的に(静脈注射を含む)投与される。とはいえ、腹膜を通じて行われ る投与は、ウィルスの複製が広範囲に亘っているリンパ系内に、少なくとも幾つ かの抗HIV剤を直接入れることができるので、より効果的である。When used for treatment, the anti-HIV agent of the present invention can be administered into the intestine (including orally) or or parenterally (including intravenous injection). However, it is done through the peritoneum. administration of the virus to the lymphatic system, where viral replication is widespread. It is more effective because the anti-HIV drug can be directly added.
本発明は更に、HIV−4及び関連ウィルスに対する、腹膜に投与されることが 好ましい、上述された薬剤の利用方法を提供する。The present invention further provides that the present invention can be administered intraperitoneally against HIV-4 and related viruses. Preferred methods of utilizing the above-mentioned agents are provided.
更に、本発明は、不活性の基剤または希釈剤を伴った本発明の抗HIV剤を含む 薬剤の組成体と、HIV−1及び関連ウィルスに対する薬剤の組成体の製造に用 いられる本発明の薬剤とを提供する。Additionally, the present invention includes anti-HIV agents of the present invention with an inert carrier or diluent. Pharmaceutical compositions and use in the manufacture of pharmaceutical compositions against HIV-1 and related viruses. The drug of the present invention is provided.
本発明は更に、本発明の有効服用量の薬剤を、患者に投与する過程を含む、HI V −1ウイルスまたは関連ウィルスを有する人間または動物の治療法を提供 する。The present invention further provides HI Providing treatments for humans or animals with V-1 virus or related viruses do.
CD4またはCD4類似物質及び抗HIVポリアニオン剤は、順番に患者に投与 されるので、HIV−1または関連ウィルスに対して用いられる場合、任意の順 序の内で、ポリアニオン剤が投与される前に、CD4またはCD4類似物質を投 与することが好ましい。CD4 or a CD4 analog and an anti-HIV polyanion agent are administered to the patient in sequence. When used against HIV-1 or related viruses, it can be used in any order. In the protocol, CD4 or a CD4 analog is administered before the polyanionic agent is administered. It is preferable to give.
従って、本発明は、CD4またはCD4類似物質が患者に対して順番に投与され る、HIV−1または関連ウィルスを保有する人間または動物の治療方法のため の、通常の抗ウィルスのための有効服用量よりも少ない量のCD4またはCD4 類似物質と、抗HIVポリアニオン剤とを提供する。Therefore, the present invention provides that CD4 or a CD4 analog is administered to a patient in sequence. for methods of treating humans or animals carrying HIV-1 or related viruses. of CD4 or CD4 in an amount lower than the usual antiviral effective dose. Similar substances and anti-HIV polyanionic agents are provided.
以下の例は、デキストリン硫酸の可溶性組み替えCD4(srCD4)との共働 作用を例示している。デキストリン硫酸は、硫黄酸化物/トリメチルアミン錯体 を用いて、約20,000ドルトンの重量平均分子量のデキストリンの硫化によ って製造され、置換の程度は、グルコースユニット当たり約1硫酸グループであ る。5rCD4は、bacu1oウィルスシステムによって製造さhSAa+e rican Biotechnology Inc、から購入できる。The following example shows the synergy of dextrin sulfate with soluble recombinant CD4 (srCD4). The effect is illustrated. Dextrin sulfate is a sulfur oxide/trimethylamine complex by sulfidation of a dextrin with a weight average molecular weight of about 20,000 daltons using The degree of substitution is approximately 1 sulfate group per glucose unit. Ru. 5rCD4 is produced by the baculo virus system hSAa+e It can be purchased from rican Biotechnology Inc.
2つの実験では、6ug/mlから0.02ug/mlへの最終的な濃度を得る ための、可溶性組み替えCD4の2倍希釈が、I−IIV−1ウイルス(HTL V−llIb 5train、 Ga11o、1984年)の2. 5 X 1 03T CI D (tissue cutture 1nfection d ose )と共に、37℃で1時間に亘って保温された。10ug/mlから0 .625ug/mlへの最終的な濃度を得るための、デキストリン硫酸の2倍希 釈が、濃度2.5X105/mlのTセルライン、M23C6に加えられ、37 ℃で1時間に亘って保温された。そして、 5rCD4/HIV−1が デキストリン硫酸のあらかじめ処理されたM8166セルに加えられ、かつ表中 の符号にプラスで示されたシンシチュームの存在を観察するために48時間から 72時間に亘って観測される平板に加えられる。Two experiments yield a final concentration of 6ug/ml to 0.02ug/ml. A 2-fold dilution of soluble recombinant CD4 was prepared for I-IIV-1 virus (HTL 2. V-llIb 5train, Ga11o, 1984). 5 X 1 03T CI D (tissue cutture 1nfection d ose) at 37° C. for 1 hour. 10ug/ml to 0 .. 2x dilution of dextrin sulfate to obtain a final concentration of 625ug/ml solution was added to the T cell line, M23C6, at a concentration of 2.5 x 105/ml and 37 It was incubated at ℃ for 1 hour. And, 5rCD4/HIV-1 Dextrin sulfate was added to the pre-treated M8166 cells and from 48 hours to observe the presence of syncytium, indicated by a plus sign. Added to the plate observed over a 72 hour period.
デキストリン硫酸が存在しないとき、5rCD4は、濃度6ug/m!(最終的 な濃度)のM8166セルへのHIV−1の感染を抑制した。5rCD4が存在 しないとき、デキストリン硫酸は、濃度5ug/mlから10ug/mlへのM 8166セルへのHIV−1の感染を抑制した。In the absence of dextrin sulfate, 5rCD4 has a concentration of 6 ug/m! (Final HIV-1 infection of M8166 cells was suppressed at a concentration of 5rCD4 is present When not, dextrin sulfate is added at M concentration from 5ug/ml to 10ug/ml. The infection of HIV-1 to 8166 cells was suppressed.
両方の薬剤が存在するとき、2.5ug/mlから1. Oug/mlの濃度の デキストリン硫酸は、濃度0,05ug / m lから0.09ug/mlの s rCD4が存在するとき、HIV−1の感染を抑制した。これは、HIV− 1の感染を防止するために必要なs rCD4の量の100分の1の減少を表し 、そして、2つの薬剤を同時に用いた場合の効果は、各々の薬剤を単独に用いた 場合の効果の合計より大きい。When both drugs are present, 2.5ug/ml to 1.5ug/ml. Concentration of Oug/ml Dextrin sulfate has a concentration of 0.05ug/ml to 0.09ug/ml. When srCD4 was present, HIV-1 infection was suppressed. This is HIV- represents a 1/100th reduction in the amount of srCD4 required to prevent infection. , and the effect of using the two drugs at the same time is the same as that of using each drug alone. greater than the sum of the effects of the case.
(以下余白) 尺諭ユ 万店 A 5rCD4が96ウエルトレイ内で希釈される。(Margin below) Shakushuyu 10,000 stores A. 5rCD4 is diluted in a 96-well tray.
2.5X103のTCID llIbを加える。Add 2.5×103 TCID llIb.
37℃で1時間に亘って保温する。Incubate at 37°C for 1 hour.
呈 デキストリン硫酸が他のウェルトレイ内で希釈される。The dextrin sulfate is diluted in another well tray.
M23C6(2,5x105/m+)を加える。Add M23C6 (2,5x105/m+).
37℃で1時間に亘って保温する。Incubate at 37°C for 1 hour.
そしてAとBを加える。Then add A and B.
正の制御が95%以上のシンシチュームを示すとき、2日から3日に亘って観測 する。Observation for 2 to 3 days when positive control shows syncytium of 95% or more do.
補正書の翻訳文提出書 平成5年3月25日Submission of translation of written amendment March 25, 1993
Claims (1)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9020872.9 | 1990-09-25 | ||
GB909020872A GB9020872D0 (en) | 1990-09-25 | 1990-09-25 | Pharmaceutical compositions and use thereof |
PCT/GB1991/001627 WO1992004909A1 (en) | 1990-09-25 | 1991-09-23 | Pharmaceutical composition comprising cd4 and a polyanionic anti-hiv agent and use thereof |
Publications (1)
Publication Number | Publication Date |
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JPH06502846A true JPH06502846A (en) | 1994-03-31 |
Family
ID=10682731
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP3515281A Pending JPH06502846A (en) | 1990-09-25 | 1991-09-23 | Pharmaceutical composition comprising CD4 and anti-HIV polyanion agent and method for using the same |
Country Status (10)
Country | Link |
---|---|
EP (1) | EP0550529A1 (en) |
JP (1) | JPH06502846A (en) |
AU (1) | AU653962B2 (en) |
CA (1) | CA2092093A1 (en) |
GB (1) | GB9020872D0 (en) |
IE (1) | IE913341A1 (en) |
NZ (1) | NZ239909A (en) |
PT (1) | PT99058B (en) |
WO (1) | WO1992004909A1 (en) |
ZA (1) | ZA917596B (en) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US5272261A (en) * | 1989-01-11 | 1993-12-21 | Merrell Dow Pharmaceuticals Inc. | Preparation of sulfated polysaccharide fractions |
GB9209874D0 (en) * | 1992-05-07 | 1992-06-24 | Ml Lab Plc | Pharmaceutical compositions |
FR2838649B1 (en) * | 2002-04-19 | 2006-01-13 | Commissariat Energie Atomique | ANTI-HIV COMPOSITION, METHOD OF MANUFACTURE AND MEDICINAL PRODUCT |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
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EP0293826A3 (en) * | 1987-06-02 | 1989-05-10 | Stichting REGA V.Z.W. | Therapeutic and prophylactic application of sulfated polysaccharides against aids |
DE3808353A1 (en) * | 1988-03-12 | 1989-09-21 | Basf Ag | COMBINATIONS OF POLYSULFATED HEPARINES IN THE FIGHT AGAINST RETROVIRUS INFECTIONS |
WO1989011860A1 (en) * | 1988-06-10 | 1989-12-14 | Biogen, Inc. | Combinations of soluble t4 proteins and anti-retroviral agents and methods for treating or preventing aids, arc and hiv infection |
IE75688B1 (en) * | 1988-07-07 | 1997-09-10 | Univ Pennsylvania | Method of modulating virus-host cell interactions using carbohydrates and carbohydrate derivatives |
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1990
- 1990-09-25 GB GB909020872A patent/GB9020872D0/en active Pending
-
1991
- 1991-09-23 CA CA002092093A patent/CA2092093A1/en not_active Abandoned
- 1991-09-23 AU AU86127/91A patent/AU653962B2/en not_active Ceased
- 1991-09-23 NZ NZ239909A patent/NZ239909A/en unknown
- 1991-09-23 WO PCT/GB1991/001627 patent/WO1992004909A1/en not_active Application Discontinuation
- 1991-09-23 EP EP91916829A patent/EP0550529A1/en not_active Withdrawn
- 1991-09-23 JP JP3515281A patent/JPH06502846A/en active Pending
- 1991-09-24 IE IE334191A patent/IE913341A1/en not_active Application Discontinuation
- 1991-09-24 ZA ZA917596A patent/ZA917596B/en unknown
- 1991-09-25 PT PT99058A patent/PT99058B/en not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
PT99058A (en) | 1992-08-31 |
PT99058B (en) | 1999-02-26 |
AU8612791A (en) | 1992-04-15 |
IE913341A1 (en) | 1992-02-25 |
AU653962B2 (en) | 1994-10-20 |
ZA917596B (en) | 1992-05-27 |
WO1992004909A1 (en) | 1992-04-02 |
CA2092093A1 (en) | 1992-03-26 |
NZ239909A (en) | 1993-02-25 |
GB9020872D0 (en) | 1990-11-07 |
EP0550529A1 (en) | 1993-07-14 |
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