**Police Raid Buyers Club At 8 in the morning on August 4, California drug agents burst open the doors of the Cannabis Buyers Club, which distributes marijuana for medicinal use to people in the San Francisco area with AIDS, cancer and other conditions. Besides making off with the club s supply of pure marijuana and dr
After the longest and bitterest budget battle in state history, New York state legislators have passed a 1997 spending plan that for the first time commits state tax dollars to the local AIDS Drug Assistance Program (ADAP). Although most other states contribute their own resources to their ADAP programs, New York until
On September 27, the FDA s Antiviral Drugs Advisory Committee will meet to consider licensing delavirdine (brand name: Rescriptor ). This Pharmacia & Upjohn product is the second nonnucleoside reverse transcriptase inhibitor (NNRTI) to come before the committee.
A thirteen-member international panel of HIV experts convened by the International AIDS Society-USA (IAS) released new antiretroviral treatment guidelines amid a turbulent crowd of demonstrators, researchers, HIV clinicians, people with HIV and AIDS and other participants of the XI International AIDS Conference in Vanc
While many left the XI International Conference on AIDS in Vancouver pondering the prospects of HIV eradication and marveling over the suggestive combination therapy data, others left impressed by how the diagnosis, treatment and prophylaxis of opportunistic infections are improving. Viral infections (
Despite the enthusiasm at the Eleventh International Conference on AIDS in Vancouver over recent advances in anti-HIV therapy, it will be a long time until there are manageable combinations of easy-to-tolerate drugs that work for everyone. New agents are needed particularly for the many individuals who already have fai
GMHC Treatment Issues, Volume 10, Number 6/7 - June/July 1996
Theo Smart
On June 7, in a rare unanimous vote, the Food and Drug Administration s ( FDA ) Antiviral Advisory Committee recommended that the agency grant accelerated approval to Boehringer Ingleheim s nevirapine ( Viramune ) for treating HIV-infected adults with evidence of decline.
GMHC Treatment Issues, Volume 10, Number 6/7 - June/July 1996
Dave Gilden
The rapidly increasing understanding of the way in which HIV gains access to new cells may lead to new strategies for stopping the virus. Last month saw the announcement of fusin, a second receptor alongside the long-known CD4 receptor to which HIV needs to bind when infecting cells (see Treatment Issues, May 1996, pag
GMHC Treatment Issues, Volume 10, Number 6/7 - June/July 1996
Gregg Gonslaves
Can HIV Be Eradicated From An Infected Individual? was the brash title of a conference held in Washington, D.C. on June 12 and 13. The new journal Antiviral Therapy and the University of Amsterdam sponsored the event, while Glaxo- Wellcome, Bristol-Myers Squibb and Gilead Sciences paid for it. Douglas
GMHC Treatment Issues, Volume 10, Number 6/7 - June/July 1996
Theo Smart
On June 3, the Food and Drug Administration ( FDA ) granted Roche Molecular Systems license to market the Amplicor HIV-1 Monitor Test (this company s HIV viral load or viral burden assay). Virtually simultaneously, guidelines on how to use the viral load tests in clinical practice, developed by a panel sponsored by the
GMHC Treatment Issues, Volume 10, Number 6/7 - June/July 1996
Gabriel Torres, M.D.
Managed care plans reimburse providers using a method called capitation. Capitation pays providers on a fixed fee-per- head (per capita) basis regardless of the types and amounts of services provided to any given individual. This directly contrasts with the traditional fee for service system in which providers are paid
GMHC Treatment Issues, Volume 10, Number 6/7 - June/July 1996
Gabriel Torres, M.D.
The cost of HIV care can be astronomical, particularly during the late stages of AIDS. At the same time, the high cost of health insurance has forced many individuals and employee groups into managed care programs such as HMOs (health maintenance organizations) devoted to providing the cheapest health care possible. Go
GMHC Treatment Issues, Volume 10, Number 6/7 - June/July 1996
Dave Gilden
Few of our survey respondents administered prophylaxis for fungal infections of any sort, although several noted that vaginal yeast infections ( candidiasis caused by the yeast species Candida albicans) were a special problem for women with HIV. These specialists also noted that such women seemed to have more
GMHC Treatment Issues, Volume 10, Number 6/7 - June/July 1996
Dave Gilden
A. Antiretroviral Therapy and Viral Load Testing 1. What antiretroviral regimen do you now recommend for your HIV-positive patients? How do you decide when to start antiretroviral therapy in an individual patient? When you consider developing a new treatment strategy for a patient, to what extent do you consider the pa
GMHC Treatment Issues, Volume 10, Number 5 - May 1995
** Glaxo, Merck and ADAP Responding to a campaign by Project Inform and the company s own Community Advisory Board, Glaxo Wellcome has broadened the financial assistance program for its new popular antiviral 3TC . Previously, Glaxo refused to provide free or discounted 3TC to anyone covered b
GMHC Treatment Issues, Volume 10, Number 5 - May 1995
Theo Smart
As Treatment Issues went to press, FDA marketing approval was imminent for Hoffmann-La Roche s Amplicor HIV-1 Monitor test kit. Approval will make the test, based on polymerase chain reaction (PCR), the first commercial method for measuring HIV in the blood, or viral load. The Amplicor kit will receive the FDA go-ahead
GMHC Treatment Issues, Volume 10, Number 5 - May 1995
Theo Smart
Progressive multifocal leukoencephalopathy (PML) can paralyze, blind, mute and kill people with AIDS within weeks. According to some estimates, the incidence of the condition has doubled in the last several years. This disease of the central nervous system presently occurs in around six percent of AIDS cases and the ra
GMHC Treatment Issues, Volume 10, Number 5 - May 1995
Derek Link
Over the last six months, FDA reform bills have progressed at a slow but steady pace through both houses of Congress (see January s Treatment Issues, pages 1-5). The Senate Labor Committee passed in late March an amended version of S.1477, Sen. Nancy Kassebaum s (R-KS) FDA bill, S.1477, now awaits consideration on the
GMHC Treatment Issues, Volume 10, Number 5 - May 1995
Dave Gilden
Two months have passed since three protease inhibitors became commercially available in the United States . In this period, the three corporate sponsors, Abbott, Merck and Roche, have jockeyed for market share, with varying degrees of success. Each of the companies products, respectively ritonavir (brand name:
GMHC Treatment Issues, Volume 10, Number 5 - May 1995
Theo Smart
A central mystery surrounding the infection of CD4 cells by HIV appears to have been solved by Edward Berger, M.D., and colleagues at the National Institute of Allergy and Infectious Diseases (NIAID). Scientists have long known that the envelope protein of HIV binds to the CD4 receptor on certain types of white blood c
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Celgene is beginning a phase II study of thalidomide as a treatment for chronic diarrhea in people with HIV. Thalidomide , already under testing for AIDS-associated wasting, commonly causes constipation as a side effect. This unwanted activity actually can be advantageous in people with untreatable diarr
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Another slowly advancing high-tech antiviral strategy is the rev mutant gene therapy investigated by Gary Nabel, M.D., of the University of Michigan. Some mutant versions of the rev protein hobble production of new HIV particles in cells by blocking the transport of necessary material from the nucleus. Dr. Nabel found
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
A persuasive presentation at the 1993 International Conference on AIDS excited many about GEM 91, the first antisense drug targeted against HIV. Antisense compounds are synthetic segments of nucleic acid that bind to viral genetic material and disrupt the viral life cycle at multiple points. In the lab, GEM 91 blocks H
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
On April 8, 1996, the FDA granted NeXstar s DaunoXome full approval as first line therapy in people with advanced HIV-associated Kaposi s Sarcoma . DaunoXome is a liposomal (lipid-encapsulated) formulation of the anticancer compound daunorubicin and is similar to Doxil (liposomal doxorubicin). Doxil (from
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Expanded access programs for the two nonnucleoside reverse transcriptase inhibitors (NNRTIs) nevirapine and delavirdine are now up and running (call 800/595-5494 for nevirapine and 800/779-0070 for delavirdine), and an FDA advisory committee hearing is scheduled for June 7 to review nevirapine s marketing application.
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
A trial to study the much heralded protease inhibitor combination of ritonavir and saquinavir is now screening applicants. Because of its liver-inhibiting properties, full dose ritonavir will raise blood levels of saquinavir about ten-fold and make this drug much mo
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Abbott Laboratories claims that the nausea commonly associated with its protease inhibitor ritonavir (brand name: Norvir ) goes away after the first few weeks in most people. The digestive upset can be minimized by progressively
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Derek Link
On March 14, a federal scientific advisory panel released its final report recommending sweeping changes in the nation s AIDS research effort. Under the leadership of Princeton University virologist Arnold Levine, Ph.D., the AIDS Research Program Evaluation Working Group spent fifteen months examining the $1.4 billion
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Gabriel Torres, M.D.
MAC ( mycobacterium avium complex ) infection occurs in eighteen to 40 percent of people with AIDS. It is most common in those with CD4 counts under 50. The symptoms and signs are quite nonspecific and protean: they can mimic those of many other infections and tumors in patients with advanced AIDS. Several lines
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Dave Gilden
One of the lasting controversies emanating from the Third Conference on Retroviruses and Opportunistic Infections held this winter (see Treatment Issues, February, 1996) was the relationship between a pregnant woman s plasma HIV levels (viral load) and transmission of the virus to her baby. With the Roche PCR and Chiro
GMHC Treatment Issues, Vol. 10, No. 4 - April 1996
Luis Santiago
This winter s Conference on Advances in AIDS Vaccine Development in Bethesda, Maryland was the eighth such meeting sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The yearly event brings together investigators from NIAID s HIV vaccine testing centers, these centers community advisory boa
GMHC Treatment Issues, Vol. 10, No. 3 - March 1996
Theo Smart
Here is yet another FDA action taken as the March Treatment Issues went to press: the agency s Blood Products Advisory Committee on March 21 reviewed an application for approval of Roche Molecular System s Amplicor HIV Monitor. This assay measures HIV RNA (viral load) in plasma. The committee appeared dumbfounded as it
GMHC Treatment Issues, Vol. 10, No. 3 - March 1996
Theo Smart
The rapid changes in the standard of care for HIV infection may have an echo in the expanding options for CMV treatment. As Treatment Issues went to press, a Food and Drug Administration advisory panel recommended approval for Gilead Sciences intravenous
GMHC Treatment Issues, Vol. 10, No. 3 - March 1996
Samuel Grubman, M.D.
ACTG 152: AZT vs. ddI and AZT/ddI ACTG 152 is a randomized, double blind trial comparing AZT monotherapy and ddI monotherapy with AZT plus ddI in HIV- infected children ages three months up to eighteen years. After an interim analysis in February, 1995, the Data Safety and Monitoring Board (DSMB) recommended closing th
GMHC Treatment Issues, Vol. 10, No. 3 - March 1996
Dave Gilden
The FDA was in classic form on March 1, when Serono Laboratories version of human growth hormone (HGH) came up for review as a treatment for AIDS-related wasting (see Treatment Issues, May, 1995). The hearing took place at a joint meeting of the endocrinologic and the antiviral drugs advisory committees. By the time th
GMHC Treatment Issues, Vol. 10, No. 3 - March 1996
Dave Gilden
As this month s Treatment Issues was preparing to go to press, the FDA announced that it had broadly approved Merck s protease inhibitor indinavir (brand name: Crixivan ) for the treatment of HIV infection in adults when antiretroviral therapy is warranted. Anticipating its product launch on March 25, Merc
GMHC Treatment Issues, Vol. 10, No. 3 - March 1996
Dave Gilden and Theo Smart
It was a frenzied set of hearings at the Food and Drug Administration February 28 to March 1. When the dust had cleared, the agency s Antiviral Drug Advisory Committee had moved toward dethroning both AZT as the centerpiece of first line anti-HIV therapy and CD4 cell counts as the main lab standard for judging drug eff
As the good news on protease inhibitors and viral load testing was broadcast from the Third Conference on Retroviruses last week, the ability of low-income people with HIV to access these promising developments was dealt a major blow. The states AIDS Drug Assistance Programs (ADAPs) are running out of money, and no sol
GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Luis Santiago
Further human trial data on hydroxyurea and compounds with similar effect were presented at the Third Conference on Human Retroviruses and Opportunistic Infections. The new data confirm the positive impression that hydroxyurea, especially, has made in past investigations (see the September, 1995 Treatment Issues, pages
GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Dave Gilden and Theo Smart
Curcumin, a component of the spice turmeric and popular herbal medicine, has no anti-HIV activity in people according to a study presented by the Community Research Initiative of New England (CRINE) at the Retrovirus Conference (abstract 140). The report stands in contrast to an earlier, smaller study by the Search All
GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Theo Smart
Several poster presentations at the Conference on Retroviruses tried to make a case for the HIV reverse transcriptase inhibitor nevirapine (brand name: Viramune ). Richard Pollard, M.D., reported on a study comparing
GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Theo Smart
Adefovir dipovixil (formerly bis-POM PMEA) is an experimental anti-HIV drug made by Gilead Sciences , which presented data on it at the Retroviruses Conference (abstract 407). It has the advantages of a very long half-life within the body (leading to a once-a-day dosing regimen) as well as broad spectrum antiviral acti
GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Theo Smart
Clinical and surrogate data were released at the Third Conference on Retroviruses from various studies of nucleoside analogs, as monotherapies or in combination with each other. In light of the profound activity of the soon to be available protease inhibitors , it may seem as though data on this more modest class of dr
GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Theo Smart
The big news at the Third Conference on Retroviruses was the extraordinary antiviral and clinical effects achieved by protease inhibitors when administered along with nucleoside analogs. The reports, although limited in their scope, suggested that combinations of anti-HIV drugs now available will be considerably more e
GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Dave Gilden
The Third Conference on Retroviruses and Opportunistic Infections took place at the beginning of this month in an atmosphere of unaccustomed optimism. There was a sense that the conference marked a watershed in the history of attempted therapies for HIV infection. Now at last, there seem to be some powerful tools to at
GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Gabriel Torres, M.D.
1592U89 is a new nucleoside analogue under development by Glaxo-Wellcome (see Treatment Issues, June 1995, page 12). It is known to have potent in vitro activity against HIV and to be synergistic with all other nucleoside analogues and protease inhibitors . At the Retroviruses Conference, Michael Saag, M.D., of the Uni
GMHC Treatment Issues, Volume 10, Number 1 - January 1996
Theo Smart
Not long after HIV was identified, many researchers noticed that it was very difficult to culture the virus from the blood of many infected people, particularly those free of symptoms. Investigating this phenomenon, Jay Levy, M.D., of the University of California San Francisco, determined that activated CD8 lymphocytes
GMHC Treatment Issues, Volume 10, Number 1 - January 1996
Gabriel Torres, M.D.
Immune thrombocytopenic purpura (ITP) is a relatively frequent condition in people with HIV infection. Although most common early in disease, it can occur at any stage of disease. Thrombocytopenia refers to an abnormally low platelet count, platelets being the blood cell fragments involved in the clotting process. Low
GMHC Treatment Issues, Volume 10, Number 1 - January 1996
Theo Smart
The first clinical trials of an HIV integrase inhibitor, Aronex Pharmaceuticals AR-177, are in progress at San Francisco General Hospital. Like reverse transcriptase and protease, integrase is an essential HIV enzyme. It binds to HIV DNA, which is created by the reverse transcriptase enzyme, and integrates that DNA int
GMHC Treatment Issues, Volume 10, Number 1 - January 1996
Theo Smart
NTZ for cryptosporidiosis Unimed Pharmaceuticals has announced FDA approval of a compassionate use program providing very limited access to nitazoxanide (NTZ), an anti-crypto- sporidial agent currently in clinical trials (see Treatment Issues, September, 1995, page 14). The company is also opening a site in San Francis
GMHC Treatment Issues, Volume 10, Number 1 - January 1996
Gabriel Torres, M.D.
Hoffmann La Roche, makers of saquinavir , the first protease inhibitor to receive FDA approval for treatment of HIV infection, has just launched a large trial to test a new, more promising formulation of the drug. The old formulation, a hard gelatin capsule with a very low bioavailability (four percent),
GMHC Treatment Issues, Volume 10, Number 1 - January 1996
Derek Link
Early in the AIDS crisis, when the epidemic s disastrous scope could not yet be imagined, AIDS activists pressed the Food and Drug Administration ( FDA ), the federal agency that regulates the testing, sale and promotion of drugs, for a faster and more humane response to this public health emergency. On October 11, 198
This information is designed to support, not replace, the relationship that exists between you and your doctor.