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Query: UMLS:C0001175 (AIDS)
 120,706 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

On May 11, 1995, community AIDS representatives met with members of the Clinical Trials subcommittee of the Inter-Company Collaboration for AIDS Drug Development (ICC) to discuss several proposals. David Barry, M.D., chairman of the Clinical Trials subcommittee, suggested an innovative trial design that would include studies of combinations of drugs (often new ones) in patients who already have resistant virus (experienced patients). By studying experienced patients, it may be possible to learn more than what would apply to just naive patients. It would also provide a surrogate marker for duration of benefit. Trials would use a small number of patients (usually under thirty) who would receive different drug combination regimens. CD4 count and viral load would be followed throughout the study. Those who do not fair well would immediately move to a different regimen. Three other proposals were discussed at the meeting. Bill Bahlman of the Treatment and Data Committee of ACT UP/New York, proposed small, uncontrolled screening trials for initial tests of new combinations. Jules Levin of the New York University Community Advisory Board, proposed comparing MK-639 (the Merck protease inhibitor) alone, versus saquinavir (the Hoffmann-La Roche protease inhibitor) alone, versus the two together. This would be a randomized, pilot study with about 90 patients, lasting 24 weeks. It would look for toxicity, changes in viral load and in CD4 count, and resistance patterns. The third proposal suggested computerizing medical records, thereby making future studies safer and faster.
AIDS Treat News 1995 May 19
PMID:New trial proposed for when drugs fail. 1136 67

Abbott Laboratories' refusal to provide any compassionate access to ABT-538, the company's experimental protease inhibitor, has caused U.S. AIDS organizations representatives to call for a protest. The first phase of the protest, scheduled from May 16 through May 22, involves representatives of some of the largest U.S. AIDS organizations calling and faxing Abbott's top executives. Representatives are requesting that Abbott set up a program this summer that will allow persons with a CD4 count under 50, who have failed approved treatments and have no other options, to receive ABT-538. Individuals can obtain an informative four-page packet by leaving a message on the voicemail of ACT UP/Golden Gate, (415) 252-9200.
AIDS Treat News 1995 May 19
PMID:Abbott: major protest over lack of access. 1136 68

The Food and Drug Administration (FDA), the government agency responsible for ensuring that drugs, vaccines, and medical devices are safe and effective, is under hot debate by Congress, the Clinton administration, and the AIDS community. The Clinton/Gore proposal favors excluding drug and biologic manufacturers from requirements for more environmental assessments and only indirectly addresses drug development. Oregon Democratic Congressman Ron Wyden introduced an FDA reform bill which calls for the FDA to use expert panels, independent testing organizations, and institutional review boards (IRB) to help speed new drugs and devices through the approval process. The bill calls for the use of the IRB for the approval (or denial) of applications for Phase I review of new drugs. Not surprisingly, the AIDS community has differing views on the reform at the FDA. The Treatment Action Group (TAG), whose members hold key positions in well-known AIDS groups, supports the status quo at FDA and is lobbying AIDS organizations across the country to sign on to its FDA Reform Principles. Other AIDS treatment activists, such as members of ACT UP, favor local IRB jurisdiction over Phase I research.
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PMID:Reform at FDA: faster access to promising drugs? Food and Drug Administration. 1136 45

Advances in organ and cell transplantation, and in basic immunology, are increasing the possibility of transplantation of organs or cells from animals to humans. Baboon immune cells are resistant to HIV infection. If the cells can survive transplantation to humans, they might conceivably provide immunological resistance to HIV. Shortly before the first test of baboon to human cell transplantation was to occur, the Food and Drug Administration (FDA) expanded its authority and told the researchers that they would have to get FDA approval before beginning. The researchers have complied, and are awaiting FDA approval. This new area involves controversial issues, including the theoretical risk of transmitting an animal disease to humans, possibly causing an epidemic. Some experts are pushing for more animal trials; while others fear that such trials will take years to finance, organize and conduct, and cannot be definitive. These issues that deal with the field of xenogeneic, animal to human, organ and cell transplantation are to be considered at an FDA meeting on July 13 and 14, 1995. Members of ACT/UP Golden Gate in San Francisco want individuals to contact the FDA and tell them that the baboon transplantation trial should go forward without delay. Community involvement and public support are needed to move this research forward.
AIDS Treat News 1995 Jul 07
PMID:Animal cell transplantation: FDA meeting July 13 and 14. Food and Drug Administration. 1136 16

A Federal appeals court has ruled that a strip-search of ten AIDS activists by U.S. marshals following a demonstration in 1989 was unlawful. In overturning a lower court ruling, the appeals court said the marshals' action violated the demonstrators' Fourth Amendment right to be free from unreasonable searches and seizures. ACT UP's Portland chapter organized picketing and a rally outside the offices of the Food and Drug Administration (FDA) in Portland. The event was nonviolent, and the protesters briefed police and the U.S. Attorney's Office in advance about the nature of the demonstration. Ten activists were taken into custody for creating a noisy disturbance in the hall outside the FDA offices. The marshals decided to strip-search the activists before booking them. The lawsuit charges that the procedures the marshals used were degrading and intrusive and without reasonable basis. The deputy who initiated the searches claimed he did so because he assumed one of the ten activists had slashed the van's tires and might have the knife secured in his or her clothing. The activists are entitled to damages from the U.S. government.
AIDS Policy Law 1995 Jul 28
PMID:U.S. marshals held liable for strip-searching AIDS activists. 1136 1

A policy statement on the Food and Drug Administration (FDA) is presented that is endorsed by the San Francisco AIDS Foundation, the National AIDS Treatment Advocacy Project, and ACT-UP/Golden Gate. The statement addresses improving compassionate access; accelerating approval refinements; allowing university-based, non-commercial businesses to have the option of applying either to a certified Institutional Review Board or to the FDA for an IND for Phase I studies; creating an appeals process; and distributing information about off-label drug use.
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PMID:Policy statement on FDA reform. Food and Drug Administration. 1136 93

The development of AIDS activism is traced and is accompanied by criticism of the lack of aggressive leadership and initiative from the public health establishment. The early 1980s marked the first attempt at aggressive AIDS activism, eventually leading to the creation of the New York-based ACT UP. ACT UP's efforts spawned public recognition, health policy development, and political action. The downfall of ACT UP is described, the current direction of AIDS activism is discussed, and ways individuals can make a difference are provided. Lacking initiative in taking action is the major problem in activism today.
J Int Assoc Physicians AIDS Care 1995 Nov
PMID:Where have all the activists gone? 1136 69

ACT UP, charging Kaiser Permanente with substandard treatment of people with AIDS, has presented the company with a list of demands. The demands include faster patient access to their own doctors and to specialists, lengthening patient hospital stays when appropriate, offering viral testing to HIV-positive individuals, paying for human growth hormone to treat wasting syndrome, allowing patients to quickly switch doctors, and helping more patients enroll in clinical trials outside the Kaiser system. The San Francisco AIDS Foundation also signed the protest and urged Kaiser to reevaluate its policy on offering primary prophylaxis for CMV disease and MAC to people with AIDS who have low CD4 T-cell counts. Kaiser responds that it gives its HIV-infected patients world-class care.
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PMID:World class care at Kaiser? 1136 14

ACT UP chapters and PWA coalitions are listed for the United States and Canada in alphabetical order by state. The National AIDS Hotline can refer HIV/AIDS patients to AIDS organizations not listed.
AIDS Treat News 1996 Jan 05
PMID:Activist groups and PWA coalitions, U.S. and Canada. 1136 81

Ten ACT UP members will each receive $20,000 as a settlement of their claims against U.S. marshals. The AIDS activists were strip-searched following a demonstration at the Food and Drug Administration (FDA) office in Portland, OR. The search violated their Fourth Amendment rights to be free from unreasonable search and seizure. The activists were shackled and strip-searched in a semi-public area. The suit charged that the marshals' actions were degrading and intrusive. ACT UP will review how government training manuals respond to AIDS-related issues and situations.
AIDS Policy Law 1996 Feb 23
PMID:Ten activists get $20,000 each as a result of illegal strip search. 1136 81


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