Subject: Hypericin; Nutrition; Montreal; Survival Date: Feb 1 1989 (516 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1989 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue # 73, Feb 1, 1989 CONTENTS: [***** appears here at each new item] Hypericin / St. John's Wort: Call for Information Nutrition and AIDS: New Task Force Recommendations Kaposi's Sarcoma: A Wide Treatment Spectrum Emerging Montreal AIDS Conference -- PWA Participation Surviving and Thriving with AIDS, Volume Two -- Collected Wisdom San Francisco: Lentinan Study Recruiting AIDS Treatment Research Delays: Major Investigative Report San Francisco: Community Research Alliance Seeks Medical Director ***** HYPERICIN/ ST. JOHN'S WORT: CALL FOR INFORMATION Several different research groups are developing protocols for clinical trials of hypericin, which is found in the St. John's Wort plant, as an antiretroviral. Any information about human experience with St. John's Wort extracts, by persons with AIDS or HIV, would help these efforts. AIDS TREATMENT NEWS is collecting information about hyperi- cin in order to publish an update, perhaps as early as the next issue. We want to find out what preparations have been used, what doses were used and for how long, and what effects, either good or bad, might have been due to the herb. We also want to hear how people feel about their overall health and well being since starting the treatment, and also about any changes in blood work. We want to know about diagnoses and severity of the disease, and about other treatments being used simultaneously. Consistent with confidentiality, we will share all information with anyone who is developing a clinical trial, as well as pub- lishing our update. For background information on hypericin, see AIDS TREATMENT NEWS issue number 63 (August 26, 1988). If you have any experience with St. John's Wort or know any- one who does, please call us as soon as possible at 415/255-0588. While we cannot accept collect calls, you can leave your number so we can call back. You can also reach AIDS TREATMENT NEWS by fax at 415/255-4659. ***** NUTRITION AND AIDS: NEW TASK FORCE RECOMMENDATIONS A task force of top AIDS physicians and dietitians has pub- lished recommendations for patients and for physicians on nutri- tional support for persons with AIDS or any HIV infection. Any- one can obtain free copies of a brochure for patients, and an article written for physicians; the article was also published in Nutrition, vol. 5 no. 1, January/February 1989. Organizations can obtain bulk copies. (See below for information on how to order.) The brochure includes specific recommendations for dealing with mouth pain or sores (which may make eating difficult, resulting in malnutrition), difficulty swallowing, diarrhea, anorexia (loss of appetite), and nausea or vomiting. It also discusses nutritional supplements, and the use of various forms of tube feeding if they become necessary. It includes basic pre- cautions for avoiding bacterial infection from raw foods. The physician's article gives much more detailed recommenda- tions for optimizing the nutritional status of patients at any stage of illness. For example, it points out that some apparently "neurological" complications are actually caused by malnutrition and are reversible. The recommendations focus on maintaining adequate intake and absorption of proteins, calories, and all other required nutrients. They do not cover the use of high doses of particular food components as possible therapies to treat specific condi- tions. The task force also commissioned its own survey, which found that "although more than 90 percent of caregivers at the major AIDS treatment centers in the United States consider nutrition important, fewer than 20 percent of the institutions have a stan- dard nutrition protocol for people with AIDS". The eleven-member task force which prepared the recommenda- tions includes Donald Kotler, M. D., gastroenterologist at St. Luke's-Roosevelt Hospital Center in New York and a leading expert on gastrointestinal complications of AIDS; Donald Armstrong, M. D., chief of infectious diseases at Memorial Sloan-Kettering Cancer Center, New York, principal investigator of the National Institutes of Health (NIH) AIDS Clinical Treatment Unit there, and member of the Scientific Advisory Committee of the Community Research Initiative; and Ranuit K. Chandra, M. D., of the Memorial University of Newfoundland, an authority on nutrition and the immune system. It was chaired by Myron Winick, M. D., professor of pediatrics and nutrition at Columbia University. The effort was funded by a grant from Norwich Eaton Pharmaceuti- cals. For a free copy of the brochure and article, write to the Task Force on Nutrition Support in AIDS, Wang Associates, Inc., 19 West 21st Street, New York, NY 10010. Bulk copies are also available. ***** KAPOSI'S SARCOMA: A WIDE TREATMENT SPECTRUM EMERGING by Denny Smith Kaposi's sarcoma occurs in about 35% of all AIDS patients. The lesions of Kaposi's usually appear on the skin and must be biopsied to confirm a diagnosis. Recently, the frequency of new KS cases has decreased. More new treatments have become avail- able, and older standard therapies for pre-epidemic KS have been adapted to deal with certain problems of AIDS-related KS. The treatments reviewed here are fresh applications of con- ventional therapy. We will look at some new KS treatments in an upcoming issue of AIDS TREATMENT NEWS. No single agent, new or newly-adapted, has yet worked conclusively. But there are com- binations which appear effective in specific stages of lesion growth. Several important factors help determine when and how to proceed against KS: the location of individual lesions, their rate of progression, the advantages of treatments weighed against their drawbacks, and the compatibility of a KS treatment choice with HIV drugs or treatments which one may require for another opportunistic infection. Where do the lesions appear? They may be localized, espe- cially around the face or lower legs, or widely dispersed, and may involve internal organs. Treatment is definitely warranted if the lesions cause functional impairment, as with swallowing dif- ficulties due to oral lesions, or pain from walking on a foot swollen from lymphatic involvement. Some lesions are treated for cosmetic reasons. For either cosmetic or functional improvement, small cutaneous (skin) lesions can be directly injected with a dilution of vinblastine (Velban), a chemotherapeutic agent. Administered weekly or biweekly for several treatments, these intralesional injections may cause temporary inflammation but can stop or even reverse the growth of some lesions. Lesions which are coalescent (merging together), or are too large for injection, or located in areas which are difficult to inject such as the eyelids or the bottom of the feet, should be treated with local radiation. We spoke with Dennis Hill, M. D., of Davies Medical Center in San Francisco regarding his applica- tion of radiotherapy for treatment of KS. He has used radiation effectively with careful dose volume and frequency for localized treatment of cutaneous lesions, and for edema, or swelling, due to internal obstruction of the lymphatics. He cautions that large volume radiation which may aggravate the underlying immune deficiency is not justified. In addition, too much irradiation of oral lesions can cause a serious inflammatory reaction in mucous tissue. But applied carefully, radiotherapy can obtain good palliative results (relief of symptoms) in many situations. Dr. Hill published his approach in Seminars in Oncology, Vol 14, No 2, 1987. Reprints of the article can be requested from the Department of Radiation Oncology, Davies Medical Center, Castro and Duboce, San Francisco, CA 94114. How aggressive are the lesions ? If there are very few lesions and they appear stable, they may not warrant the risk of various unwanted treatment side effects. But if new lesions appear to be progressing rapidly in size or number, they should be treated before they become a functional or cosmetic problem. To inhibit rapid progression, or to deal with slower lesions for which Velban injections or radiotherapy are not useful, a sys- temic approach with chemotherapy might be considered. The most commonly used agents against AIDS-related KS are vincristine, vinblastine, etoposide, doxorubicin (Adriamycin), and bleomycin. There is evidence and general agreement that a combination of some of these drugs is more successful than any one used singly, but there is no consensus for which combination, dosage or frequency. The best combination would obtain an effec- tive cytotoxic strength (able to kill KS cells) without corresponding damage to healthy tissue. For example, in addition to their anti-KS activity, vinblastine, etoposide, and doxorubi- cin can each suppress bone marrow production (myelosuppression), etoposide and doxorubicin are associated with alopecia (hair loss), and vincristine can cause neuropathy. One solution is to alternate the administration of different agents to avoid cumula- tive toxicity while maintaining anti-tumor effect. Another approach is to balance the dose and frequency such that multiple agents can be used simultaneously. We interviewed Ivan Silverberg, M. D., also of Davies Medi- cal Center in San Francisco. Dr. Silverberg has obtained good responses with a combination of 1 mg vincristine, 3 mg vinblas- tine, and 5 units bleomycin, given intravenously once a week. The side effects may include a fever after the infusion, and some minimal hair loss. He has not seen any serious toxicity with this ratio. One friend of ours adapted this combination to 1/2 mg vincristine and 2 mg vinblastine with 5 units bleomycin and after three months decreased the injections to once every two weeks. He felt that his lesions were completely stabilized. In recent months, two different AIDS newsletters published their own thorough coverage of KS treatment options with a large focus on chemotherapy. Allen Maniker, M. D., wrote for the October 20th, 1988 Treatment Issues, published by the Gay Men's Health Crises, 129 West 20th St., N. Y., NY 10011. Lawrence Kaplan, M. D., was the author of an article in the January 1989 "AIDS Medical Report"", published by American Health Consultants in Atlanta, 800/554-1032. Both articles provide a detailed back- ground for people making treatment choices for KS. How can these choices be integrated into a workable program of AIDS treatments? With any HIV-related illness, the root prob- lem is an immune deficiency, so treatment choices must aim care- fully to avoid further damage to the immune system. The optimum treatment program would include anti-HIV treatments and possibly an immunomodulator if blood counts call for them and if they are chosen for compatibility with the appropriate KS therapy. Some- times there is a conflict of treatment strategy between an HIV drug such as AZT and an anti-KS agent like doxorubicin, because they both suppress bone marrow production. But AZT can be admin- istered safely with radiotherapy or non-myelosuppressive drugs such as vincristine. We have heard reports of people with Kaposi's sarcoma being refused treatment on the assumption that it progresses too slowly to be of concern, or that there are no effective treatments any- way. But many physicians and patients have successfully stabil- ized lesion growth with flexible combinations of intralesional injections, radiation or chemotherapy. In a future article we will compare new and investigational KS treatments, including interferon, laser therapy and the prosorba column. ***** MONTREAL AIDS CONFERENCE -- PWA PARTICIPATION Last week we spoke with Don DeGagne, who is representing persons with AIDS on the program committee of the V International Conference on AIDS -- the major scientific conference of 1989, to be held in Montreal, Quebec in June. After extensive criticism of lack of PWA participation at the previous international AIDS conference in Stockholm, the Canadian AIDS Society and PWA groups lobbied for representatives of community-based groups and PWAs to be involved at Montreal. The organizers of the conference have responded: * "AIDS, Society, and Behavior", one of the nine modules of the conference, is expected to have persons with AIDS in all of the 20 themes within that module; * PWAs will be part of the opening ceremony, at least one plenary session, and many panels, discussion groups, and forums. For example, Mr. DeGagne himself is putting together a workshop, "Living with AIDS", in which persons with AIDS from five dif- ferent regions of the world will talk about their experiences. There will also be a workshop on how to organize coalitions, a concept unfamiliar in some parts of the world. Before the Conference itself, which begins on June 4, there will probably be a two-day pre-conference for persons with AIDS and community-based organizations, so that people can meet each other and organize. Persons making flight reservations should know that this pre-conference may be occurring; for more informa- tion, call Don DeGagne at the number below. An audiovisual module will be part of the Conference. Per- sons with any visual materials related to AIDS can still submit them, even after the February 1 deadline for scientific abstracts. For more information, contact Ken Morrison at the V International Conference on AIDS. We asked about PWA involvement in the San Francisco Confer- ence, next year. Mr. DeGagne "would strongly urge the organizers of the VI International Conference on AIDS, which will be held in San Francisco at the end of June in 1990, to follow the path of the Montreal Conference by including persons with AIDS in all aspects of the event itself, as well as its planning stages. Collaboration between the groups, consumers as well as doctors and researchers, is a primordial thing. PWAs should be involved from the beginning -- for San Francisco, that means now -- or it will be hard to catch up later." What about cost? Registration is $450.00 (Canadian), and there is no reduced rate for PWAs to be admitted to the Confer- ence. But there is an organization for housing, so if there is a problem with paying for hotels, contact Mr. DeGagne at the Van- couver PWA Coalition (phone number below). Mr. DeGagne urged that organizations raise funds and lobby for funding so that persons with AIDS will be able to attend. The Canadian government will subsidize the cost of attending for 300 persons from third-world or developing countries. For more information about PWA organizing and involvement, you can reach Don DeGagne by leaving a message at the Vancouver PWA Coalition, 604/683-3381. For registration or other informa- tion about the V International Conference on AIDS, which will take place June 4-9 in Montreal, you can obtain a registration packet from the Secretariat, 514/874-4006. ***** ANNOUNCEMENTS SURVIVING AND THRIVING WITH AIDS VOLUME TWO -- COLLECTED WISDOM People with AIDS Coalition New York has published volume two of Surviving and Thriving with AIDS, edited by Michael Callen -- a 368-page book written by persons with AIDS. (The first volume, subtitled Hints for the Newly Diagnosed, is being reprinted; 20,000 copies have previously been distributed.) The new volume is subtitled Collected Wisdom. "The two books are meant to be read together, and in order," according to Michael Callen. "Hints is still essential reading for the newly diagnosed. Collected Wisdom expands upon the information and ideas contained in Hints. It's an anthology of our attempts to cope with AIDS. It's a slice of life which cap- tures what it is like to live with AIDS in America in the late '80s." Volume two contains a large section on treatment options, including AZT, aerosol pentamidine, DHPG, TPN, AL 721, and holis- tic approaches. These treatments are described firsthand by peo- ple who have used them. The personal accounts include practical perspectives on the decision to use or not use certain treat- ments. They also give practical hints discovered from personal experience, such as treating thrush and leukoplakia by opening an acyclovir capsule and spreading the contents on one's tongue before going to bed. Other sections include emotional responses to diagnosis, long-term survivors, love and sex and AIDS, family and friends, women and AIDS, people of color and AIDS, AIDS in prison, politi- cal responses, dealing with disability, social security, and Medicaid, resource lists, and an index. Throughout the book the firsthand accounts, and pictures, tell much of the history of the development of the PWA advocacy and treatment movements. Both volumes are offered free to persons with AIDS or ARC; prices for the general public are $10. for volume one and $20. for volume 2. We urge those who can afford to contribute more to do so. To obtain either or both volumes of Surviving and Thriving with AIDS, send a check to the PWA Coalition, 31 West 26th Street, New York, NY 10010, 212/532-0290. ***** SAN FRANCISCO: LENTINAN STUDY RECRUITING Persons who are HIV positive, have T-cell counts between 200 and 500, and are not using other antiviral or immune modulator treatments, are needed for a three-month study of lentinan at the AIDS Clinic at San Francisco General Hospital. To be eligible, volunteers can be either asymptomatic or mildly to moderately ill, but cannot have AIDS. Lentinan, an extract of the shiitake mushroom which is given intravenously in 10-minute infusions once per week, has been used in Japan to treat thousands of cancer patients, with very little toxicity. It has immune potentiating effects, and may also be antiviral against HIV. The San Francisco study will look for both effects by blood tests. (For earlier background on lentinan, see AIDS TREATMENT NEWS issue #19, December 5, 1986.) Persons entering the trial will be randomly assigned to one of four groups: 2 mg per week, 5 mg, 10 mg, or placebo. There is one chance in four of getting the latter. However, the pla- cebo is given for only eight weeks (followed by four weeks off treatment, to see what happens when the lentinan is stopped); and the study will be ended early if any dose is found to be clearly effective. And if the lentinan proves effective, all volunteers who complete the study will probably have access to it "open label" (without placebo) without charge; however, this access is not guaranteed. Aerosol pentamidine and some other treatments are OK during the trial. AZT is probably not. The study is being conducted by Donald Abrams, M. D., Eric Goosby, M. D., and Roberta Wong, Pharm. D. Financing is from Ajinomoto Co., Inc., Yokohama, Japan, through Lenti-Chemico Phar- maceutical Laboratory, Inc., Teaneck, New Jersey. Forty patients are being recruited (10 for each arm of the study). If you meet the qualifications above and are willing to volunteer, call Vince De Genova at San Francisco General Hospi- tal, 821-5089. Comment This study is important for the community. Lentinan might be an effective therapy for delaying or preventing the develop- ment of AIDS in persons at early stages of illness. A trial should have been done four years ago, but there was no money then for a U. S. trial, and there were not enough patients in Japan. Dr. Abrams originally designed the San Francisco study without a placebo. The FDA asked that the placebo arm be added, because if the drug does seem to work it will never again be pos- sible to test it against a placebo, and researchers will be less confident that improvement seen in trials is really due to the drug. We believe that the placebo is justified in this case. The randomized treatment lasts only eight weeks; the trial is designed to look for blood changes, not serious illness or death. Ten people (not hundreds) will get the placebo. And if the study shows that the drug does work, it will have more credibility and more quickly become available to thousands of people. This study design is workable and can answer important ques- tions about the drug. We hope that people will volunteer in order to help the AIDS community, despite the personal sacrifice of giving up other treatments temporarily. ***** AIDS TREATMENT RESEARCH DELAYS: MAJOR INVESTIGATIVE REPORT A four-part series on delays in AIDS treatment development is appearing Monday, January 30 through Thursday, February 2 in the San Francisco Chronicle. We have seen only the first part by press time, but already this series looks like the most comprehensive report of AIDS drug delays ever published in a major newspaper. Experts and officials who have long been afraid to tell the public what is wrong in AIDS research have spoken more openly in this series than ever before. The reporter, Chronicle correspondent Randy Shilts, also wrote And the Band Played On (new edition from Penguin Books, New York, 1988), a history of earlier Federal mismanagement of AIDS prevention, education, and research. To obtain the San Francisco Chronicle articles, you can order back issues by mail for 60 cents each from San Francisco Newspaper Agency, attn. Back Copies, P. O. Box 7228, San Fran- cisco, CA 94120-7228. Copies are only available for 90 days from publication date. Or within 30 days of publication, you can pick up the papers between 10AM and 3PM Monday through Friday at 190 5th Street (at Mission), for 25 cents each. Or you can always obtain these or any other published articles through a document delivery service, such as Dynamic Information in Redwood City, CA. ***** SAN FRANCISCO: COMMUNITY RESEARCH ALLIANCE SEEKS MEDICAL DIRECTOR The Community Research Alliance (see "Community Research Alliance: New San Francisco Effort for Community-Based Trials", AIDS TREATMENT NEWS number 70, December 1, 1988) is hiring a med- ical director, seeking a physician with experience in clinical research and with AIDS. This person will evaluate ideas for clin- ical trials, help physicians or others write formal protocols for submission the the organization's Scientific Advisory Committee, supervise data management and quality control of research, assist principal investigators with analysis of results, and coordinate with physicians, community groups, pharmaceutical companies, hos- pitals, clinics, and research organizations. The position is half time for now and may become full time later. It pays competitive salary commensurate with clinical and research experience. Call Community Research Alliance, 415/626-2145, or send resume to 273 Church Street, San Francisco, CA 94114. ***** STATEMENT OF PURPOSE AIDS TREATMENT NEWS reports on experimental and complemen- tary treatments, especially those available now. It collects information from medical journals, and from interviews with scientists physicians, and other health practitioners, and per- sons with AIDS or ARC. Long-term survivors have usually tried many different treat- ments, and found combinations which work for them. AIDS TREAT- MENT NEWS does not recommend particular therapies, but seeks to increase the options available. We also examine the ethical and public-policy issues around AIDS treatment research. ***** [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display