AIDS Prevention and Services: Community Based Research

By Johannes P. Van Vugt | Go to book overview

five years, and that operated in continual crisis amid mounting losses from AIDS, those advances are a proud legacy.


NOTES
1.
The original definition of AIDS preceded the discovery of HIV. As originally defined by the U.S. Centers for Disease Control (CDC) in 1982 and revised in 1985 and 1987, AIDS includes any of a constellation of opportunistic infections and cancers that occur in people with immune suppression. This suppression characteristically manifests itself by drastically lowered levels of a white blood cell subset called T4 lymphocytes (also called CD4 cells). Healthy HIV negative persons usually have about 900-1,500 CD4 cells per cubic millimeter of blood. When people with HIV- associated immune suppression experience a drop in T4 helper cells to below 250/ mm3, their risk for the following opportunistic complications becomes acute:
• PROTOZOAL INFECTIONS, such as pneumocystis carinii pneumonia (PCP), toxoplasma gondii encephalitis, cryptosporidium parvum and microsporidium colitis, isospora belli, and others;
• BACTERIAL INFECTIONS, such as mycobacterium tuberculosis (MTB), mycobacterium avium complex (MAC), neurosyphilis, and many infections of the gastrointestinal system;
• VIRAL INFECTIONS, such as herpes simplex, herpes zoster (shingles), cytomegalovirus (CMV) retinitis and colitis, JV-virus-associated progressive multifocal leukoencephalopathy (PML, a rare brain disorder), and papilloma-virus--associated cervical and anal cancers;
• FUNGAL INFECTIONS, such as meningitis caused by cryptococcus neoformans, histoplasma capsulatum, and disseminated candida (thrush);
• OPPORTUNISTIC CANCERS, such as Kaposi's sarcoma, the unchecked proliferation of new blood vessels, B-cell lymphomas, and cervical and anal cancers.

The current AIDS definition is not regarded as definitive. Because the initial surveillance of AIDS was mainly conducted upon gay men, the definition reflects just a portion of the immune deficiencies associated with HIV infection. Many conditions more common in women, injecting drug users, and people of color are omitted from the CDC case definition.

2.
Clinical drug trials are experiments conducted on humans. In the United States, all clinical trials are regulated by the FDA, a branch of the U.S. Public Health Service. The FDA does not actually conduct drug trials, however. The trials are carried out by academic researchers at medical schools, with funding from the NIH or from drug companies. In the case of AIDS research, about 40 percent of the drug trials are sponsored by the NIH and 60 percent by drug companies. Before a trial can enroll participants, the FDA must approve the trial plan, or protocol. Traditionally, the experimental drug is available only through a clinical trial. Clinical trials are conventionally divided into three phases:
Phase I trials are the first studies done on humans. A small number of people (generally under 100) are enrolled and closely monitored. These trials look at pharmacokinetics, or how the drug is metabolized in the body; at safety and tolerance, or what side effects are associated with the drug; at the maximum tolerated dose (MTD), to see when unacceptable side effects occur; and at activity, or preliminary evidence for efficacy against the condition for which the drug is being studied.

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