As we go to press, Congress is about to pass legislation which supposedly targets computer pornography, but which will in fact restrict all two-way public discussion by computer, on all topics, even those completely unrelated to sex. AIDS TREATMENT NEWS is developing a World Wide Web site, to serve as a directory and a
Representatives of the major companies with anti-HIV protease inhibitors in human use will discuss their results and plans at a free educational forum, Saturday January 6, 1:00 p.m. to 4:30 p.m., at New York University Medical Center, Farkas Auditorium, East 31st Street and 1st Avenue (entrance on 1st Avenue). There wi
Since its founding in 1987, the AIDS Clinical Trials Group (ACTG) has been the largest network of research centers studying AIDS treatments in people; it is operated by the National Institute of Allergy and Infectious Diseases, the primary agency of the National Institutes of Health (NIH) sponsoring AIDS research. Over
The Third Conference on Retroviruses and Opportunistic Infections, which may be the second most important AIDS meeting of 1996 (after the International Conference in Vancouver in July) will be held at the Sheraton Washington Hotel in Washington, D.C., January 28-February 1; preregistration deadline is December 29, late
Results of two early trials of mitoguazone (MGBG) for advanced cases of AIDS lymphoma have encouraged investigators to study the drug in people with newly diagnosed lymphoma, and especially in those with lymphoma of the central nervous system. Susan Smith, a representative of MGBG s developer (ILEX, San Antonio, Texas,
Oxandrolone (brand name Oxandrin(R); an earlier name, Anavar , is obsolete) is an oral anabolic steroid which is not primarily metabolized in the liver. It became available in the U.S. in December 1995. Anabolic agents work by promoting protein synthesis, and are one approach to the treatment of wasting syndrome, which
A major trial in cities throughout the U.S. will compare triple combination therapy with the Merck protease inhibitor ( indinavir , brand name Crixivan (TM)) plus
Two separate placebo-controlled studies of ritonavir , the Abbott protease inhibitor, were reported December 7 in the NEW ENGLAND JOURNAL OF MEDICINE. Both reported good viral load and CD4 results. A 32-week study in 84 patients in The Netherlands , Sp
Abbott Laboratories will make its protease inhibitor ritonavir (formerly called ABT-538) available to 2,000 people worldwide, in an expanded access program starting in January. Since many more than 2,000 are expected to apply, a lottery will be used to select who gets the drug.
Saquinavir (brand name Invirase (TM)), developed by Hoffmann- La Roche, was approved by the FDA on December 6, and is currently available in pharmacies. It is the first of a new class of anti-HIV drugs, called
A House/Senate conference committee will shortly meet to sort out conflicting proposals passed by the two houses of Congress aimed at restricting online access to obscene or indecent material and other matter deemed objectionable. AIDS activists and service organizations are concerned that some of the proposals under c
Californians for Compassionate Use has begun a drive to collect 600,000 signatures of registered voters by April 15, to get the Medical Marijuana Initiative on the November 1996 ballot. This requires collecting several thousand signatures a day, seven days a week -- a difficult task for a volunteer organization. If it
A national poll released this month by the American Civil Liberties Union found that over 80 percent of U.S. voters believed there should be legal access to medical marijuana when it has been proven effective, or when people with serious illnesses find it effective for their medical needs. The ACLU hired polling profes
Researchers at the National Institutes of Health urgently need to find identical twins, only one of whom is HIV- infected. The immediate need is for a single blood donation from each person, to help answer certain scientific questions that will affect future research directions. There may also be an opportunity to enro
A clinical trial at 25 sites across the U.S. is now enrolling 225 volunteers to compare three different combination anti- HIV treatment regimens. Participants must have a CD4 count between 200 and 500, and not have previously used antiretrovirals. The trial will last one year. Each volunteer will be randomly assigned t
An important government study is now recruiting 120 volunteers with advanced KS to compare DOXIL alone vs. DOXIL plus BV (bleomycin and vincristine). Everyone in this trial will get DOXIL; half of the participants will get the other drugs too. Both treatment will be given every two weeks, for a maximum of 25 treatments
DOXIL (R), a liposomal form of the chemotherapy drug doxorubicin which allows much higher concentrations to be delivered to Kaposi s sarcoma lesions or cancer tumors, has been approved by the FDA , under the accelerated approval regulations. It currently has received a fairly narrow indication, for the treatment of
PMPA is the experimental anti-HIV drug which gained national attention in mid November, after a government-funded study, published in SCIENCE (1), reported that once-daily doses for four weeks completely protected macaque monkeys from SIV (a virus which is closely related to HIV) even when given 24 hours after exposure
On November 17 the FDA approved the marketing of lamivudine (brand name Epivir (TM), but still best known by the code name 3TC ) for use in combination with AZT
A major bill on FDA reform and the entire drug-development process is likely to be introduced by Senator Nancy Kassebaum -- a moderate Republican who has been helpful on important AIDS issues -- probably during the next few weeks. The bill has not yet been made public; we obtained a recent (undated) 76-page discussion
AIDS TREATMENT NEWS Issue #235, November 17, 1995 \
John S. James
Saquinavir , the protease inhibitor developed by Hoffmann-La Roche (and recently recommended for approval by the FDA Antiviral Advisory Committee despite general agreement that the dose which will be approved is too low) has very low bioavailability -- only about 4% of
Viral resistance to protease inhibitors has become a major concern in the HIV community. The immediate issue is that saquinavir ( Invirase (TM)), (an experimental protease inhibitor developed by
A proposal for a joint U.S./Chinese research collaboration for research on traditional Chinese medicine, to be based in San Francisco, is drawing increased professional and community support. Any such cooperation will be important for AIDS research. For example, China has sent several research teams to
Reasons for Hope, a highly recommended series of monthly AIDS treatment articles, is now available from Search for a Cure, a nonprofit organization in Boston. These articles explain advanced practical treatment options to persons who are newly diagnosed, or otherwise do not have much background in AIDS treatment. The
A government study of 215 volunteers with AIDS-related cognitive impairment found no proof that peptide T was helpful for treating this condition. The volunteers were randomly assigned to receive either peptide T (intranasally, up to six mg/day) or placebo for six months; for the next six months, everyone was given pep
The AIDS Survival Project, an Atlanta, Georgia coalition of people affected by HIV, is seeking a full-time treatment resource specialist. This program-management position involves treatment activism as well as supervising and maintaining a large treatment resource library. Applicants need the ability to work with a wid
Hoffmann-La Roche has changed its trial of the protease inhibitor saquinavir , due to new information from the ACTG 175 trial and the Delta trial showing that AZT alone was inferior to
The U.S. Centers for Disease Control has started a phone and fax service for information about cryptosporidiosis. Callers can listen to recorded messages, or receive printed information by fax. The phone number is 404/330-1242.
Hoffmann-La Roche also recently started a CMV Retinitis Screening Program, to teach patients at risk for CMV retinitis to recognize symptoms of the disease between doctor visits, so that they can get rapid treatment. Patients can obtain a kit -- including a videotape Recognizing CMV Retinitis, a brochure, and an Am
On October 31 Hoffmann-La Roche announced that it had received FDA approval to market oral ganciclovir (Cytovene(TM)) for prevention of CMV disease in persons with advanced HIV infection. Oral ganciclovir had previously been FDA approved, but only for maintenance treatment of CMV retini
[This is our statement to the Office of AIDS Research NIH AIDS Research Program Evaluation Working Group Area Review Panel on Clinical Trials, November 13-14 (see notice above). [Do not rely on us to get this message across. We cannot attend the meeting, and we missed the deadline for advance distribution of this state
The Office of AIDS Research (OAR) -- which recently was given budgetary authority over the U.S. National Institutes of Health (NIH) AIDS research program, which is by far the world s largest -- is finishing up a one-year process of evaluating AIDS research at NIH. Due to a closed, secretive atmosphere around this evalu
The outline of a compromise to an intense dispute about access to thalidomide as a potential treatment for wasting syndrome -- a dispute that could have led to FDA raids on the largest AIDS buyers clubs -- appears to have been reached at an October 24 meeting of the buyers clubs, thalidomide developer
THE HIV DRUG BOOK, a well-organized guide to what patients should know about the major drugs used to treat HIV and opportunistic infections, has just been published and is now reaching bookstores. We believe that everyone interested in AIDS treatment should have a copy of this important reference, published by Pocket B
Several dozen clinics and physicians practices in the San Francisco area are now enrolling volunteers in a study of testosterone replacement for men who have abnormally low testosterone levels. This study will compare testosterone injections every two weeks with replacement by a patch which is worn daily on the scrotum
On October 12 California Governor Pete Wilson vetoed legislation that would have allowed bottled water or home- filtration systems as a Medi-Cal (Medicaid) benefit to those most in need of safe water. Wilson also vetoed a bill to allow persons with AIDS, cancer, and other major diseases to use medical marijuana, and an
The Internet newsgroup called sci.med.aids, probably the most widely distributed AIDS information on the Internet, is now moving and has new email addresses. sci.med.aids is an electronic mailing list which allows you to post information which is then distributed around the world, and likely to reach over 70,000 people
On October 16 the PWA Health Group, the largest buyers club in New York and the activist group most expert on issues around thalidomide , protested tentative plans to make patients pay to participate in a randomized clinical trial, when they needed compassionate access to thalidomide to treat wasting syndrome.
The XI International Conference on AIDS will take place in Vancouver, British Columbia, July 7-12, 1996. Space is tight and the best time to make arrangements is now -- not only for presenters and organizations, but for anyone attending. Deadlines start as early as February 1. The International Conference on AIDS now o
The FDA Antiviral Drugs Advisory Committee will hold its most important meeting for a long time on November 6-8 in Silver Spring, Maryland. The FDA usually follows the recommendations of this committee concerning drug approvals. Public testimony will be accepted during a half hour each day. Three different drugs will b
About 130 people will be invited from around the country to a one-day White House Conference on HIV and AIDS on December 6. The invitees will include people living with HIV and AIDS as well as experts in the areas of research, prevention, care, discrimination, and health and income support. The program is still being p
[Note: The following are the initial guidelines for using viral load, which are being provided to physicians in the CPCRA 036 study described above. These guidelines will be reviewed periodically throughout the study, and will be changed as new information becomes available.] The goal of utilizing plasma HIV RNA quanti
A new kind of trial which focuses on treatment strategy instead of testing individual drugs is now recruiting 1,100 volunteers with CD4 (T-helper) counts of 300 or less, in the following cities: Albuquerque, Atlanta, Baltimore, Camden NJ, Chicago, Denver, Detroit (2 sites), New Orleans, New York City, Newark, Philadelp
We who report AIDS research and treatment information cannot help but see how poorly this information gets disseminated -- and how relatively easy it would be to make huge improvements. Obstacles to scientific publishing seriously slow medical research itself, as well as harming efforts to communicate results to physic
Not all the research presented at the San Francisco ICAAC meeting (the Inter-Science Conference on Antimicrobial Agents and Chemotherapy; see coverage in AIDS TREATMENT NEWS #231, and in following issues) was dramatically important, but much of it could help answer the small, day to day questions that both doctors and
A new statewide initiative to allow medical use of marijuana when recommended by a physician will soon be starting a drive for signatures to get onto the California ballot in 1996. On September 29 the initiative was submitted to the California Attorney General, who has five weeks to change the wording and write the tit
A new drug which in laboratory tests greatly weakens virus which becomes resistant to it has entered an early human trial at sites in Los Angeles, in New York, and at Stanford University, near San Francisco. This three-month study will randomly assign volunteers to either the new drug (called HBY 097, developed by Hoec
[Note: On September 14, the U.S. study ACTG 175 results were released, showing that AZT plus ddI or AZT plus ddC worked better than AZT alone in preventing progression to AIDS or death (see AIDS TREATMENT NEWS #231, September 29, 1995).
[Note: Jules Levin is an organizer of the Protease Working Group, which has taken the lead in persuading Merck & Co. , and Abbott Laboratories , to make their protease inhibitors available on expanded access, which neither company had planned to do.
The Drug Policy Foundation, an organization devoted to reshaping the debate on the failed American approach to drug abuse, is holding its ninth annual conference in Santa Monica, October 18-21, at Loews Santa Monica Beach Hotel. Among the conference workshops are discussions of drug reform under the Republicans, harm r
Both houses of Congress are developing legislation which would greatly reduce Medicaid (Medi-Cal in California) coverage over the next seven years, and at the same time remove Federal standards for health care for the poor by converting the remaining Medicaid money into medical block grants that each state can spend as
At the FDA workshop on clinical trials (September 6 and 7, with associated meetings on September 8; see discussion in AIDS TREATMENT NEWS #228 and #229), our major goal was to put our proposal for symptom-reduction trials onto the table for discussion. We were impressed with the openness of people to considering this k
Hoffmann-La Roche announced on September 18 that it will have additional supplies of the protease inhibitor saquinavir (trade name, Invirase (TM)), and will conduct a second lottery for expanded access to the drug, which is in
Hoffmann-La Roche is recruiting for a 90-patient trial to compare different doses of a new formulation of saquinavir , its protease inhibitor, with the conventional formulation now being used in major clinical trials and in the expanded- access lottery. The new formulation is the same drug, but deliver
Laboratory evidence suggests that two protease inhibitors , Abbott s ritonavir and Roche s saquinavir , might work particularly well together. (But caution: this combination will be very dangerous unless the dose of
Saquinavir , a protease inhibitor developed by Hoffmann-La Roche , is currently in large-scale clinical trials at a dose of 1800 mg per day (600 mg three times a day). [Recently a new formulation of the same drug has been developed to increase the low bioavailability of
Agouron Pharmaceuticals, Inc. of La Jolla, California, is developing a protease inhibitor called AG 1343, trade name Viracept (TM). Two small studies, each checking the tolerability and antiviral activity of different doses of the drug, in slightly different formulations, were presented at the late b
A clinical trial in France with about 25 volunteers combined ritonavir (the Abbott protease inhibitor) with AZT plus ddC , in patients who previously were untreated. The combination achieved a 2.
A major government study has found that AZT alone was inferior to AZT plus ddC or AZT plus ddI combination therapy , or to ddI alone, in patients starting with a CD4 (T-helper) count between 200 and 500.
Most AIDS conferences leave a sense of disappointment, of how little new or significant work has been done. But ICAAC 1995 -- the 35th annual Inter-Science Conference on Antimicrobial Agents and Chemotherapy, in San Francisco September 17-20 -- was clearly different -- and important. ICAAC focuses on new antibiotics fo
Chiron Corporation is sponsoring a small trial to observe how viral load, measured by their branched DNA (bDNA) test, responds to various treatment changes. Participants must plan to make a change in their HIV treatment (either starting or stopping either a mainstream or alternative treatment) -- but get the first vira
Our interview with Dr. Conant published in issue #228, August 4, 1995, left some readers confused about the d4T dose Dr. Conant is using. For some patients, he increases the dose until it is twice the dose recommended by the FDA in the product labeling. The following statement in the interview is correct
Thalidomide has already been available through a compassionate-use program for treatment of certain cases of aphthous ulcers, and some other conditions. But until now patients could not obtain the drug through this program for the treatment of HIV-related wasting syndrome, where thalidomide might also be effective.
The long-awaited French study of hydroxyurea plus ddI appeared August 28 in the JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES AND HUMAN RETROVIROLOGY. It reported good antiviral activity and CD4 count improvement in a 90-day trial with 12 patients who started with a high CD4 count. Viral load (measured by plasma HIV
Thomas M. Sinclair, M.S., L.Ac., Diplomate, National Board of Acupuncture Orthopedics, has treated people with HIV for eight years. He is executive director of the Immune Enhancement Project in San Francisco. AIDS TREATMENT NEWS interviewed him August 22, at the IEP office in San Francisco s Castro district. ATN: Where
In July the House Appropriations Committee eliminated the separate line item for AIDS research at the National Institutes of Health, and with it the authority of the Office of AIDS Research to control the NIH AIDS budget. The Senate will deal with the matter in September. This action does not necessarily reduce funding
In a move that may bode well for AIDS educators and activists, the House of Representatives acted in late July to block Senator James Exon s (D-NE) Communications Decency Act. Exon s measure, an amendment to the telecommunications deregulation bill, contained sweeping language barring obscene, indecent or harassing co
Bastyr University s AIDS Research Center will award two to five grants, totaling $105,000, for the investigation and evaluation of promising therapies currently in use for treating people with HIV or AIDS. Applicants should obtain a copy of the RFA (Request for Applications), send a letter of intent as soon as possible
Persons who registered for the Crixivan (Merck protease inhibitor) program (see AIDS TREATMENT NEWS #227, July 21, 1995; registration for the initial selection closed August 11) should make sure they receive the one-page patient qualification form, which must be filled out and faxed or postmarked by September 8.
The FDA has issued a warning that persons with HIV, or with liver disease, or with certain other medical conditions, should avoid eating raw oysters because of the risk of infection with the bacterium Vibrio vulnificus. The risk is especially great in oysters from the Gulf of Mexico, especially during warm months, Apri
The Problem Currently, definitive efficacy trials (such as the confirmatory trials to prove clinical benefit of drugs which have been given accelerated approval) are laboring under ground rules which make these studies extremely difficult to accomplish in today s treatment environment. The critical problem is the defin
A number of proposals for changing the FDA -- mostly to get treatments to patients faster -- or to avoid changing the FDA in ways people do not want, are now circulating in Washington and across the country. This article looks at reform efforts by AIDS activists. Also, a number of FDA reforms have already been introduc
It appears that this workshop (see FDA Workshop on Clinical Trial Design, September 6-7 -- Registration by Aug. 18) has been requested to address profoundly wrong issues. It is being asked to design trials to meet the requirements of the accelerated approval regulations. Worse, the official announcement of the workshop
The FDA will hold a public workshop on the design of HIV clinical trials, September 6-7, 8:30 a.m. to 5:00 p.m., in Bethesda, Maryland. Following the workshop there will be a joint meeting of subcommittees of the Antiviral Drugs Advisory Committee and the National Task Force on AIDS Drug Development, on September 8. Bo
A trial at Beth Israel Hospital in Boston is seeking 18 volunteers for a trial of a new kind of treatment vaccine. Volunteers must have a CD4 (T-helper) count over 500, no antiretroviral use for six months prior to entering the study, no use of immunosuppressive agents, and must be asymptomatic and generally in good he
As this issue goes to press, AIDS Treatment News has heard that Medi-Cal will pay for human growth hormone through the Serono treatment IND, for some patients, starting August 1. Serono will start processing Medi-Cal applications on that date. Physicians and patients will still apply for the program in the same way, by
In April, Glaxo (now Glaxo Wellcome ) restricted its expanded- access program for 3TC , due to unexpected demand and a resulting shortage of the drug. The most important restriction instituted at that time is that patients had to have a CD4 (T-helper count) under 100, instead of under 300, to qual
Marcus Conant, M.D., heads the Conant Medical Group, one of the largest HIV practices in San Francisco. AIDS Treatment News: How has your approach to treating HIV infection changed since a year or two ago? Dr. Conant: Today when we find that someone is HIV positive, we are using three indicators, instead of one or two,
Cryptosporidiosis is caused by a microscopic parasite, Cryptosporidium parvum, and may cause severe diarrhea. Persons with normal immunity get cryptosporidiosis, but recover without treatment within several weeks. In persons with immune deficiency, however, the disease can be life- threatening; there are treatments whi
One part of the case for AIDS research funding is that this research advances our understanding of the immune system, which is critically important in many other diseases, including cancer and many autoimmune conditions. But it can be hard to identify concrete benefits, because it takes time for the new knowledge to be
On July 17, the National Association of People with AIDS (NAPWA) opened MedExpress, an air-express pharmacy, which will focus on services to people with HIV, as well as on providing low-cost medications. In addition to all FDA-approved medications, nutrients, and supplements at low prices, MedExpress will provide each
The controversial Communications Decency Act of 1995, frequently referred to as the Exon amendment, after its author, Sen. James Exon of Nebraska, may interfere with both AIDS prevention efforts and the work of AIDS activists if it becomes law. The measure, an amendment to the Telecommunications Competition and Deregul
In Part I of this interview, in AIDS TREATMENT NEWS #226, Dr. Poscher discussed treatment strategies, including her use of combination antiretrovirals, and the role of acyclovir , ganciclovir, and some other treatments. That interview is continued, below.
Merck & Co. has announced an open-label (expanded-access) program to make its experimental protease inhibitor available to persons with a CD4 (T-helper) count of 50 or below. This drug, now called Crixivan (TM) (generic name, indinavi
If you have used NAC (N-acetylcysteine) for at least three months, you could help a scientific study at Stanford University by completing the survey below. This survey is to tell the researchers why you are using the treatment -- and what effects you have seen, good or bad. NAC has long been one of the most popular tre
Advances in organ and cell transplantation, and in basic immunology, have now raised the possibility of transplantation of organs or cells from animals to humans. For example, it is known that immune cells in baboons are resistant to HIV infection. If these cells could survive transplantation to humans, and could work
The May issue of Treatment Issues, published by GMHC (the Gay Men s Health Crisis, in New York), includes several excellent articles on treatment of wasting syndrome -- severe loss of lean body mass not due to obvious causes such as nutritional deficiency or intestinal infection -- in AIDS. The bottom line is that ther
In a widely distributed June 21 press release, Hoffmann-La Roche announced details of The Invirase * International Compassionate Treatment Program. This program will distribute saquinavir (brand name, Invirase), a protease i
Margaret Poscher, M. D., is an internist in private practice with Quest, a five-physician medical group in San Francisco. Dr. Poscher is also Assistant Clinical Professor, University of California Medical Center, and Director of HIV Clinical Services, University of California Mt. Zion. ATN: Which antiretroviral combina
The interview with Dr. Margaret Poscher, below, is the first in a series of articles and interviews on combination anti-HIV treatment. For over a year, it has been almost a cliche that combination treatment is the wave of the future; however, the actual data on how well drug combinations work in people has been, and st
In strongly worded letters of May 18 and May 19, the World Bank tried to persuade the British journal AIDS not to publish an editorial review on AIDS prevention by researchers at the Center for AIDS Prevention Studies of the University of California. AIDS published the article anyway (Peter Lurie, Percy Hintzen, and Ro
A record number of individuals concerned about AIDS converged in Washington D.C. May 21-23 to learn about Federal AIDS issues and to lobby members of congress. This grassroots effort, coordinated by the National Association of People With AIDS and co-sponsored by 26 national organizations, brought together over 500 adv
Federal employees with a life-threatening illness can improve their financial condition by tens of thousands of dollars by taking advantage of a special open season, which ends July 21. During the open season, employees who are not insured can enroll in life insurance up to slightly over their annual salary, with NO ph
The State of California Department of Health Services asked us to let our readers know that Medi-Cal can pay private insurance premiums, in some cases. This benefits the individual because private insurance is usually better than Medi-Cal. And California likes the program because it has saved an estimated $22 million f
A study comparing Chinese medicine to conventional antibiotics for treatment of sinusitis is now recruiting. The study is being run by the Immune Enhancement Project, which has reported good clinical results with traditional Chinese medicine for treating this condition. Participants must have recurrent sinusitis docume
Educational materials on cancer and AIDS pain management are now available on the World Wide Web (http://www.roxane.com/). Materials include newsletters, clinical articles, slides, a schedule of upcoming seminars, and the cancer pain management guidelines from the U.S. Agency for Health Care and Research. [Technical no
Protocol 39, Merck s study of the protease inhibitor MK-639 in persons with CD4 count under 50, will recruit 420 patients at 12 U.S. sites. Enrollment should start in June or July. Other patients will be recruited in Canada , Australia , France , Germany
An inexpensive, non-invasive electrical measurement predicted three-year survival better than CD4 (T-helper cell) count or any of several other measurements tested, in a recently reported prospective study of 75 patients.(1) In 1990, when the study began, the 75 patients had an average CD4 (T-helper) count of 176.2, an
Testing for the number of copies of HIV RNA (the viral load test) is becoming more common in medical practice. But this test is not yet officially approved for use in managing patients. Therefore, health insurance and managed-care plans often refuse to pay for it. (Some do pay, perhaps because they realize that the tes
A prospective study of 62 patients found that viral load was the best marker available for predicting who would progress to AIDS: * Those who had a viral load of over 100,000 copies per ml on their first measurement after seroconversion were more than ten times as likely to develop AIDS as those who did not, during the
In San Francisco, where Chinese medical treatment has been funded for three years by the Ryan White CARE Act, the American College of Traditional Chinese Medicine has treated over 300 symptomatic HIV-positive patients in long-term care. A study of the medical records of these patients, and of quarterly health surveys,
The Treatment Action Group (TAG) has published a 64-page booklet on the current status of AIDS-related lymphoma . THE LYMPHOMA PROJECT REPORT: CURRENT ISSUES IN RESEARCH AND TREATMENT OF AIDS-ASSOCIATED LYMPHOMA, by Michael Marco, with an introduction by Lawrence D. Kaplan, M.D., is based on interviews with dozens of e
Leading AIDS scientist Robert Gallo, M.D. is leaving government service after 30 years at the U.S. National Cancer Institute, to start the Institute of Human Virology, which will be part of the University of Maryland system. The new Institute will focus on AIDS, but will also do research in other human viral diseases,
The HIV pandemic is fourteen years along, affecting at least that many millions of lives, with no certain end in sight. New treatments are winding their way through laboratory studies and clinical trials, but not at a pace that reassures people who now have AIDS. For many, it is a situation defined by anxiety. Yet long
Saccharomyces boulardii is a live yeast widely used in Europe and elsewhere to treat diarrhea; millions of doses are sold each year. Recently, with increasing interest in using it for HIV-related diarrhea, this potential treatment has become one of the top sellers at some AIDS buyers clubs, including Healing Alternativ
In March 1995, 18 new drugs were added to the California AIDS Drug Assistance Program; these are in addition to the 25 drugs already there. These drugs can be fully or partially reimbursed for persons with HIV with moderate incomes. Funding is from the Federal Ryan White Title II program. The following drugs are now in
On May 18, a coalition of mainstream religious leaders, working with Jeremy Rifkin of the Foundation for Economic Trends, who has long opposed many uses of biotechnology, will hold a press conference opposing the patenting of human and animal life forms, body parts, and genes. The biotechnology industry has been surpri
Hundreds of people across the U.S. are calling and faxing the executives and directors of Abbott Laboratories , of Abbott Park, Illinois, over the company s refusal to provide any compassionate access to ABT-538, Abbott s experimental protease inhibitor. The first phase of the protest was scheduled from May 16 through
The Eighth International Conference on Antiviral Research took place April 23-28, 1995, in Santa Fe, New Mexico. In our last issue, AIDS TREATMENT NEWS reported results on d4T , and on the Agouron protease inhibitor, which were presented at this meeting. But over two hundred other research reports were al
On May 11 this writer and other community representatives met with members of the Clinical Trials subcommittee of the Inter-Company Collaboration for AIDS Drug Development (ICC). The ICC is a group of 17 major pharmaceutical companies which have agreed to share information to facilitate more rapid development of AIDS t
The following list is mainly for conferences and meetings with substantial information about research and development of treatments for AIDS-related conditions. However, we have also included some others which may interest our readers. Because of the many changes in arrangements, we did not list events unless we could
Early results from a handful of patients, reported at the Santa Fe meeting of the International Society of Antiviral Research, show that the protease inhibitor AG1343, being developed by Agouron Pharmaceuticals of La Jolla, California, does have biological activity against HIV in people. This finding is important becau
The expanded access program for 3TC has in the past required a CD4 count of under 300. But due to the greatly increased demand for the drug after reports of good results with the combination of 3TC and AZT , Glaxo was unable to manufacture enough, and announced on Ap
On April 7 AIDS TREATMENT NEWS reported that some volunteers had had trouble enrolling in ICC 001, the first trial by the Inter-Company Collaboration for AIDS Drug Development, a consortium of 15 major pharmaceutical companies. At some sites, the volunteers may have had to pay for pre-screening blood tests, which requi
Two studies by researchers at Stanford University have questioned conventional wisdom on AIDS by finding a relatively early, selective loss of naive CD4 and CD8 cells in both HIV infected adults and children, respectively. In view of these results, important beliefs about the pathogenesis of HIV disease will need to be
A major study of d4T (generic name stavudine, brand name Zerit ) has shown that patients who have been using AZT did significantly better in disease progression if they switched to d4T than i
The last issue of AIDS TREATMENT NEWS gave contact numbers for information about volunteering for trials of MK-639, the experimental protease inhibitor developed by Merck and Co. Since we went to press, the numbers for Canada , Spain , and Switzerland have changed.
HIV-associated sensory neuropathy ( peripheral neuropathy ), a condition resulting from degeneration of nerves caused by HIV infection or by some treatments for HIV, results in pain and disability in up to 30 percent of people with advanced HIV infection; it is the most common neurological complication in AIDS. Several
[Note: In our last issue, AIDS TREATMENT NEWS published a proposed monitoring program for getting reliable data from the very first use of a new treatment. The proposal below is an alternative approach to getting data early. It was developed by Bill Bahlman, an activist with the Treatment and Data Committee of ACT UP/N
The drug thalidomide has lately become the object of wide- ranging research for its proposed value in treating a number of AIDS-related conditions, including aphthous ulcers, wasting, and tuberculosis , as well as for treating HIV infection itself. If its promise holds true, thalidomide will become pharmaceutical medic
AIDS TREATMENT NEWS would like to hear from physicians, other medical professionals, and patients about any cases of striking, unusual, or unexpected reduction in viral load. This request was inspired by a case in which viral load went from 483,000 copies in January 1994 to 26,000 in August 1994; the only treatment cha
The Problem With the development of protease inhibitors and other new approaches for treating HIV disease, there are more potential treatments, and many more combinations, which are worth trying. At the same time, the resources available for research, both public and private, may be shrinking. Efforts toward small, rap
Log Cabin Republicans, a gay and lesbian Republican organization, has formally petitioned the FDA to speed approval of three drugs -- 3TC , saquinavir , and MK-639. The petition states that it should be possible to approve 3TC by Sept
Far-reaching FDA reforms are now being proposed by Congressional Republicans, who may have the votes to force major changes in how FDA operates. The goal of many of these changes is faster and less expensive approval of important new drugs; but some proposals could also increase the risk of ineffective drugs being appr
The drug topotecan, being developed as a cancer treatment by SmithKline Beecham, will be made available to certain outside researchers interested in studying its possible use in treating HIV or PML (progressive multifocal leukoencephalopathy). Prospective researchers must have their pre-clinical or clinical plans appro
The National AIDS Treatment Information Project, funded by the Kaiser Family Foundation, is producing a series of fact sheets of AIDS treatment information, to be available in June of this year. The information, designed for self-education and for counseling by community advisors, case managers, social workers, and cli
A baby who was HIV infected at birth appears to have cleared the virus and become HIV-negative, according to an article in the March 30 NEW ENGLAND JOURNAL OF MEDICINE. Viral culture tests were positive at 19 and 51 days of age, but all later tests have been negative. Because samples were saved, the virus could be test
Starting April 3, Glaxo is limiting enrollment in its 3TC expanded access program to 350 new patients per week in North America. In late March, 800 per week or more had been enrolling. Those who qualify for the program will be placed on a waiting list, first come first serve. This means that number 351 in one week will
The last issue of AIDS TREATMENT NEWS included information on enrolling in ICC 001, the first study of the Inter-Company Collaboration for AIDS Drug Development, a consortium of 15 major pharmaceutical companies. However, there is a potential problem in the enrollment process that we did not know about when that issue
Two large trials of the Merck protease inhibitor MK-639 are now recruiting in the U.S. One is for people who have never taken AZT or other antiretrovirals (less than two weeks is permissible), and the other is for those who have used AZT. Protocol 033: AZT Naive This trial is seeking 780 volunteers who have not tak
The first of a series of trials of the Inter-Company Collaboration for AIDS Drug Development (ICC) is now enrolling. These trials are particularly important for at least two reasons: (1) The ICC is an association of 15 pharmaceutical companies set up to share information and otherwise facilitate the testing of drug com
Note: The following statement was developed by many people, collectively calling themselves the Protease Consensus Coalition. It has been signed by 61 organizations, including ACT UP/New York Treatment and Data Committee, AIDS Project Los Angeles, AIDS Research Alliance (formerly Search Alliance), AIDS Treatment News,
Merck and Co. has devoted extraordinary resources and taken the lead in overcoming production problems of the current generation of protease inhibitors . In mid March it announced that its comparative trial and open-label protocol for persons with a CD4 (T-helper count) under 50 -- expected to start in mid 1995 -- coul
David Feigal, M.D., is Director of the Division of Antiviral Drug Products of the U.S. Food and Drug Administration. After the February 23-24 meeting of the National Task Force on AIDS Drug Development, a meeting focused on protease inhibitors , we asked Dr. Feigal for his perspective on issues related to the current d
One provision of the Republican Contract with America could benefit persons with AIDS -- tax relief on the money received from a life insurance policy before death, by a person with a short life expectancy due to illness. Under current law, death benefits paid by life-insurance companies are not taxable. Or if the poli
A drug widely used to treat arthritis and other autoimmune disorders may significantly increase CD4 counts in people with HIV. The drug, sulfasalazine, also known by the trade name Azulfidine, is an anti-inflammatory agent originally approved to treat ulcerative colitis, but like many drugs its uses have expanded to in
The February 23-24 meeting of the National Task Force on AIDS Drug Development focused on protease inhibitors ; our report on that meeting was not finished in time for publication in this issue. Below is our oral and written testimony to the Task Force. We were surprised by the widespread agreement with our statement o
The Immune Restoration Think Tank, sponsored by San Francisco-based Project Inform, brings together an invited group of leading researchers from around the world for a three-day informal meeting to plan future research directions on immune restoration in late-stage AIDS, and to develop new collaborative projects. The f
Results of the leading study of interleukin-2 ( IL-2 ), an experimental immune-based treatment for HIV, were published in the NEW ENGLAND JOURNAL OF MEDICINE on March 3. While this research, conducted by H. Clifford Lane, M.D., and 12 other researchers at the U.S. National Institute of Allergy and Infectious Diseases,
The FDA s Oncologic Drugs Advisory Committee voted eight to zero to recommend that DOX-SL be given accelerated approval for treatment of AIDS-related Kaposi s sarcoma (KS) in patients who have failed conventional treatment. Under accelerated approval, the company will be required to conduct additional research, continu
A government study of treatment for children with symptomatic HIV infection was stopped early after those treated with AZT alone showed worse survival than those in at least one of the comparison treatment groups. ACTG 152 compared AZT alone, ddI alone, and the combination of AZT plus ddI, for treating children from th
In an unexpected setback for Burroughs-Wellcome -- but one which might turn into good news for people with AIDS -- a study of valacyclovir was stopped early because patients assigned to that drug had worse survival than those in either the low dose or high dose acyclovir arms, which were intended as control groups for
One of the functions of a publication such as AIDS TREATMENT NEWS is to provide information about clinical studies of new treatments. Often those of us who report on AIDS trials hear that potentially important studies are having trouble enrolling the number of volunteers needed. The problem is quite common. Ronald Mits
On February 14 AIDS TREATMENT NEWS interviewed William E. Paul, M.D., Director of the Office of AIDS Research at the U.S. National Institutes of Health (NIH). The new Office of AIDS Research, due to Congressional action in 1993, has budgetary authority over all AIDS research at NIH -- the world s largest AIDS research
The future of AIDS research, prevention, human rights, and care will depend on how well we explain the need to the larger public, and also on how well we establish a grassroots culture in which tens of thousands of people regularly speak out to their elected representatives, the media, and others, as a part of everyday
The Community Consortium, an organization of HIV care providers in the San Francisco Bay Area, is now offering the use of a computerized data base by which people with HIV can quickly and easily find out about local clinical trials. The project is called Trials Search, and is a free service to any Bay Area resident.
With no International Conference on AIDS this year (in the future, that meeting will occur only in even-numbered years), the Second National Conference on Human Retroviruses and Related Infections, January 29 - February 2 in Washington, D.C., with about 2300 people attending, was probably the largest conference on AIDS
On February 3 AIDS TREATMENT NEWS interviewed Bruce Lehman, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks, in his office near Washington D.C. We had requested the interview to discuss proposals for giving priority to inventions for serious or life-threatening illnesses -- a recommendation m
The U.S. Patent and Trademark Office (PTO) will now allow AIDS and cancer patent applications to receive top priority review, PTO Commissioner Bruce Lehman told AIDS TREATMENT NEWS on February 3. The new priority applies only if the patent applicant requests it, and the request is approved by the PTO. The new change is
The Oncologic Drugs Advisory Committee will consider approval of DOX-SL, for persons with AIDS-related Kaposi s sarcoma who have failed systemic chemotherapy, either because of toxicity or because of disease progression. This meeting, which is open to the public, will be at the FDA s Parklawn Building, in Rockville, Ma
The February 23-24 meeting of the National Task Force on AIDS Drug Development (NTFADD), especially February 23, may be a pivotal moment in the development of protease inhibitors . Activists want the NTFADD to appoint an official protease inhibitor task force which can work effectively to find ways to make the drugs ac
As 1995 begins, we have more opportunities for progress toward major improvement in AIDS/HIV treatments than ever before. And we have clear, feasible paths to follow -- of safe, rapid, low-cost, high-quality treatment trials in people, to get solid preliminary information on how certain potential treatments work in pra
Foscarnet (Foscavir) is an antiviral used to treat CMV ( cytomegalovirus ) infection; it is also used in serious cases of acyclovir-resistant herpes simplex . It is active not only against CMV (which is a member of the herpesvirus family) and herpes simp
On January 12, many newspapers carried page-one stories about a major scientific advance in understanding AIDS. Some of the reporting has been unclear and confusing to readers, however. This article will outline what the discovery is and why it is important to people with HIV or AIDS. We will also explain our concern t
Biotechnology investors had a terrible year in 1994. This is bad for people with AIDS, because it makes it hard for companies to raise money to develop new treatments and test them. BioCentury, a weekly fax newsletter which reports on the business of biotechnology, found that only the largest companies, with market cap
[Note: Each year AIDS TREATMENT NEWS publishes a list of treatments to watch during the coming year. Our list for 1995 was not ready for this issue; it will probably appear in issue #215.] As of this writing (January 6), it is too early to know what threats to AIDS research, care, and prevention will come from the new
In December 1993, researchers at Johns Hopkins University published results from a study (funded by the U.S. National Institutes of Health) of 280 volunteers, who were studied for an average followup of 6.8 years, which found that dietary intake of certain vitamins was associated with substantially reduced risk of prog
A study of 768 women and 3779 men with HIV found that the women had a one-third higher risk of death then the men -- and yet no higher risk of progressing to AIDS -- after statistical adjustment for stage of illness. The cause of the difference is unknown. The study was conducted by the Terry Beirn Community Programs f
On January 26, two advisory committees of the FDA (the Antiviral Drugs Advisory Committee, which considers most AIDS drugs, and the Vaccines and Related Biological Products Advisory Committee) will meet jointly to consider future clinical trials of the HIV-1 Immunogen, a potential AIDS treatment developed by Jonas Salk
On January 5, Syntex (a Palo Alto, California pharmaceutical company recently acquired by Hoffmann-La Roche ) announced that the U.S. Food and Drug Administration had approved oral ganciclovir for marketing. Ganciclovir (Cytovene() has long been an approved drug widely used for treating
This information is designed to support, not replace, the relationship that exists between you and your doctor.