Date: Tue, 29 Aug 1995 09:16:17 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: CDC AIDS Daily Summary 08/29/95 AIDS Daily Summary August 29, 1995 The Centers for Disease Control and Prevention (CDC) National AIDS Clearinghouse makes available the following information as a public service only. Providing this information does not constitute endorsement by the CDC, the CDC Clearinghouse, or any other organization. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC Clearinghouse should be cited as the source of this information. Copyright 1995, Information, Inc., Bethesda, MD ************************************************************ "FDA Allows AIDS Patients to Try Thalidomide" "North American Biologicals to Acquire Univax for About $150 Million in Stock" "Thai-U.S. Military Team Launches AIDS Vaccine Trial" "Indonesia Hospital Scolded for Rejecting AIDS Case" "Chiron and Univax to Collaborate on Development of Vaccine-Based Human Immunotherapeutic Products" "Battling HIV/AIDS" "Update: HIV-2 Infection among Blood and Plasma Donors--United States, June 1992-June 1995" "Potential Mechanism for Sustained Antiretroviral Efficacy of AZT-3TC Combination Therapy" "New Antiviral Strategies: Interview with Marcus Conant, M.D." "Depressive Disorder and HIV Disease: An Uncommon Association" "FDA Announces Public Workshop and Advisory Subcommittee Meeting on Current Issues in AIDS Clinical Trials" ************************************************************ "FDA Allows AIDS Patients to Try Thalidomide" Baltimore Sun (08/29/95) P. 18A Celgene Corp. will offer thalidomide as a treatment for AIDS-related wasting under a new program approved by the U.S. Food and Drug Administration (FDA). The tranquilizer caused birth defects throughout Europe during the 1950s. Celgene will hold clinical trials to determine whether its version of the drug, called Synovir, fights the extreme weight loss and deterioration characteristic of wasting. In a move that represents the broadest use of thalidomide in the United States, the FDA is permitting the company to administer the drug experimentally to any AIDS patient who is wasting and has other infections, malignancies, has failed treatments, or is close to death. Related Stories: Wall Street Journal (08/29) P. B8; Philadelphia Inquirer (08/29) P. A2; Washington Times (08/29) P. A5 "North American Biologicals to Acquire Univax for About $150 Million in Stock" Wall Street Journal (08/29/95) P. A4; Frank, Robert Univax Biologicals Inc. will be acquired by North American Biologicals Inc. for approximately $150 million worth of stock, providing Univax with much-needed capital and manufacturing capabilities. The agreement will unite North American Biologicals' large supply of blood plasma and financial strength with Univax's extensive line of plasma-based products and vaccine technologies for a range of immune disorders, including HIV. Analysts say the combined company will have about $250 million in revenue by 1996, with projected revenue for the year 2000 estimated at $450 million. Related Stories: Washington Post (08/29) P. D1; Baltimore Sun (08/29) P. 11C; Washington Times (08/29) P. B10 "Thai-U.S. Military Team Launches AIDS Vaccine Trial" Reuters (08/29/95) A combined Thai-U.S. military medical team has just launched a trial of a potential AIDS vaccine made by the U.S. firm Chiron Biocine, called SF2 gp120/MF 59. Thus far, two Thai volunteers have been injected with the drug, but 22 more will also receive the trial drug during the first phase of the experiment, which will last six months, according to Lieutenant General Kamrob Saisuwan of the Armed Forces Research Institute of Medical Sciences (AFRIMS). AFRIMS represents a research body of medical specialists from the U.S. Army, the Thai Army, and Thailand's Chiang Mai University. U.S. Army Colonel Rodney Michael said that the vaccine has already been tried in the United States and that "it proved to be safe with no side effects." "Indonesia Hospital Scolded for Rejecting AIDS Case" Reuters (08/28/95) The Indonesian government has admonished a hospital for rejecting an AIDS patient and refusing to let a physician treat that person. The Jakarta hospital, Medistra, was reprimanded because it had violated a ministerial decree on AIDS prevention, according to Hadi Santoso, chairman of Jakarta's Health Ministry Office. "The policy of the Health Ministry does not allow discrimination against sufferers of any disease, including AIDS," Santoso explained. Although he offered no details of the reprimand, Santoso said the hospital has agreed to let the doctor care for AIDS patients again. The official Antara news agency reported on Monday that Medistra's director said that the hospital sent the patient away because it lacked the information on how to treat the disease. "Chiron and Univax to Collaborate on Development of Vaccine-Based Human Immunotherapeutic Products" Business Wire (08/28/95) Chiron Corp. and Univax Corp. have signed an agreement-in-principle to establish a long-term collaboration for the development of human immunotherapeutic products based on Chiron Biocine's vaccines. Under the agreement, Univax has the exclusive global rights to Chiron Biocine's vaccines for use as immunizing agents. Initially, the program will focus on the development of a form of cytomegalovirus (CMV) hyperimmune globulin product to fight off and treat CMV infections. "This agreement will provide the new Univax/NABI combined entity with a pipeline of viral and bacterial vaccines and a safe, well-characterized adjuvant, which could generate a new and expanded line of efficacious antibody products," said Tom Stagnaro, Univax's president and CEO. "Battling HIV/AIDS" Chicago Tribune (08/28/95) P. 1-12; Buchanan, Thomas E. In a letter to the editor of the Chicago Tribune, Thomas E. Buchanan--executive director of Horizons Community Services, the Midwest's largest and oldest provider of social services to the Chicago gay and lesbian community--expresses his support for the recommendations of the Presidential Advisory Council on HIV/AIDS. In particular, Buchanan notes the work of council member Robert L. Fogel, who has greatly advanced the group's goal of providing data and recommendations to the president on HIV- and AIDS-related issues. The council's early recommendations include a call for a national summit involving the scientific, medical, social, and political aspects of the epidemic; and opposing amendments to HIV-related bills that are meant to separate people on the basis of their sexual orientation, substance use history, race, or ethnicity. Buchanan urges President Clinton to support the council's recommendations, and to hold a National Summit on AIDS in Chicago this year. "Update: HIV-2 Infection among Blood and Plasma Donors--United States, June 1992-June 1995" Morbidity and Mortality Weekly Report (08/18/95) Vol. 44, No. 32, P. 603 Since the implementation of HIV-2 screening for all donated blood three years ago, two cases of HIV-2 infection have been identified. The first donation was rejected in June 1994 after it tested positive in a combination HIV-1/HIV-2 enzyme immunoessay (EIA) and indeterminate in an HIV-1 Western blot test. The donor was born and lived in the United States, and denied use of injection drugs, receipt of transfusions, and travel outside the country. She had had four male sex partners since 1982, all of whom were born in the United States and whose HIV status was unknown. The woman has received counseling--including instructions not to donate blood, blood products, and tissues and organs--and a referral to a healthcare professional. The second donation also was rejected after testing HIV-2-positive in Nov. 1994. This donor was born in France and had lived in western Africa between 1979 and 1985 before coming to the United States. While in Africa, he was twice vaccinated with improperly cleaned and reused needles, and received several tattoos. In addition, the majority of his 35 lifetime sex partners were African. He too, received HIV counseling and a referral to a healthcare worker. "Potential Mechanism for Sustained Antiretroviral Efficacy of AZT-3TC Combination Therapy" Science (08/04/95) Vol. 269, No. 5224, P. 696; Larder, Brendan A.; Kemp, Sharon D.; Harrigan, P. Richard Because current monotherapeutic treatment of HIV-1 infection is associated with only limited benefits, drug combinations that effectively reduce HIV-1 replication and delay drug resistance are desperately needed. To better understand the significance of the resistance-producing mutations that occur in reverse transcriptase (RT), Larder et al. conducted in vitro growth competition experiments with pure virus populations containing either Val or Ile in RT. The mutant strains of HIV-1 that were resistant to AZT became phenotypically sensitive due to a single mutation at codon 184 of viral RT to valine, which also produced 3TC resistance. In addition, there was no co-resistance to both AZT and 3TC observed during in vitro selection with both drugs. In vivo combination therapy with the two drugs produced a significantly larger drop in serum HIV-1 RNA concentrations than monotherapy with AZT. The valine-184 mutants, however, developed very quickly. Even after 24 weeks of treatment, the majority of the samples from the combination group remained sensitive to AZT, which is consistent with mutation studies done in vitro. "New Antiviral Strategies: Interview with Marcus Conant, M.D." AIDS Treatment News (08/04/95) No. 228, P. 1; James, John S. In an interview with AIDS Treatment News, Dr. Marcus Conant--head of the Conant Medical Group, one of the largest HIV practices in San Francisco--notes that compared to a few years ago, there are now "three indicators, instead of one or two" to determine an individual's level of HIV infection. Although the data has become more complex, he says, "it has become easier to use, because the viral load can give us more information than all of the others put together." For patients with evidence of disease progression, Conant initially prescribes increasingly high doses of d4T. If the patient reaches the maximum dose and the CD4 count falls to levels that qualify for the 3TC expanded-access program, he puts them on a combination of AZT and 3TC. He waits until the two drugs can be started together because "it [does] not seem to make sense to put them on AZT alone for a year or two, let the virus get resistant to that drug, and then add the drug that helps to prevent the emergence of resistance." However, if 3TC were approved, he would likely start a regimen of AZT, 3TC, and ddC "much earlier in the course of the disease." Meanwhile, Conant says he is very excited about the Abbott and Agouron protease inhibitors, and predicts that protease inhibitors--not nucleoside analogs--could become the first line of therapy. "Depressive Disorder and HIV Disease: An Uncommon Association" Focus (08/95) Vol. 10, No. 9, P. 1; Rabkin, Judith G.; Remien, Robert H. Despite the perception that HIV infection may cause depression, evidence suggests that there is seldom a cause-and-effect relationship between the two, write Rabkin and Remien--both professors of psychology at the College of Physicians and Surgeons at Columbia University. Early reports of psychiatric morbidity among HIV-infected individuals revealed extremely high rates of symptomatic depression and anxiety. However, more recent studies show rates among seropositive gay men, for example, to be about the same those of seronegative gay men. It is important to note that most HIV-infected persons will probably experience bouts of sadness and distress--often in relation to the illness or death of friends--but this is to be expected. Diagnosis of depression may be hampered by the fact that both it and HIV produce similar somatic or physical symptoms, including fatigue, lethargy, low appetite, and weight loss. Some have suggested, but not confirmed, that HIV itself causes mood shifts and that HIV-related dementia causes depression. There is little proof, however, to back up either of these theories. In general, most evidence does not support "a measurable or substantial effect" of psychosocial factors such as depression or stress "on [enumerative measures of] the immune system in relation to physical disorders such as AIDS." While it is understandable that therapists might think that individuals faced with disability, pain, and death could become depressed, the assumption that clinical depression affects all or the majority of HIV-infected persons is wrong, the authors state. Statistics show that the disorder is no more common among HIV-positive individuals than uninfected persons, and is not likely to increase as the disease progresses. "FDA Announces Public Workshop and Advisory Subcommittee Meeting on Current Issues in AIDS Clinical Trials" U.S. Centers for Disease Control and Prevention () The U.S. Food and Drug Administration is holding a public workshop on current issues in HIV clinical trials on Sept. 6 and 7, 1995. At the workshop--to which registration is required--members of the industry and the public will be able to discuss issues regarding the design and conduct of clinical trials of drugs for the treatment of HIV, as well as propose strategies for overcoming known obstacles. A major challenge to developers of HIV treatments is the successful design and conduct of clinical confirmatory trials, which are needed to provide the data used to confirm the clinical benefit of drugs that have received accelerated approval. The workshop will be followed by a joint meeting on Sept. 9 of subcommittees of the Antiviral Drugs Advisory Committee and the National Task Force on AIDS Drug Development. The subcommittees will hear summary presentations from the workshop, and will discuss recommendations on the scientific design of future HIV clinical trials. For more information, call the AIDS Clinical Trial Information Service at (800) 874-2572.