Page 6 GAY PEOPLES CHRONICLE February, 1989

LIVING WITH AIDS

by Joseph Interrante Director of Education Health Issues Taskforce

Participating in Clinical Trials

This column is the first in a series exploring issues around clinical trials of experimental AIDS treatments. Whether to participate in a trial or not can be an extremely difficult decision. It is vital that people considering participation understand both the general trial process and the specific criteria of a particular trial, so that they can make a truly informed decision about participation.

The language in which trial protocols (a trial's plan of action) are written can itself be intimidating. So, let's begin with terms. A clinical trial is one involving humans as test subjects. Clinical trials use certain criteria to determine whether a person qualifies to be part of the study or should be excluded. Some of these criteria are designed to protect against possible harm to subjects (for example, a preg-

nant woman when the drug could damage the fetus). Other criteria are designed to ensure that researchers get the results they want from a study---i.e., that the results are due to the drug being tested, and not to other factors.

These criteria have been the subject of great controversy, over whether certain groups of people have been excluded from access to trials and whether such criteria subordinate or ignore the needs of PWAS. These issues will be discussed in a future column. Important here is the fact that people considering participation in a trial will be asked to fill out a survey and to undergo certain tests to determine whether they are eligible to participate.

Clinical trials are either controlled or uncontrolled. A controlled study divides its subjects into two or more groups. One of these groups, the control group, receives no drug, gets standard treatment or receives a placebo. A placebo is usually a substance that looks like the drug under

OSU shows AIDS art

The Ohio State University Gallery of Fine Art will present an exhibition entitled, "AIDS: The Artists' Response," which will include the work of artists, artists' collectives, and AIDS service organizations from the United States, Canada and Great Britain. The exhibition will run from February 24 through April 16 in the Hoyt L. Sherman Gallery, Sullivant Hall, 1813 N. High Street on the campus of the Ohio State University. Organized by AIDS activists Jan Grover and Lynette Molnar, the exhibition will offer paintings and photographs, as well as film, video, installations, performances, and theater pieces. The exhibition highlights the wide range of work produced since 1982 and focuses on the diversity of human response to the epidemic: grief, loss, heroism, compassion, and political action.

A second component of the exhibition features posters, pamphlets, flyers, and other public service announcements produced by AIDS service organizations from around the world.

In conjunction with the exhibition, the University Gallery will host "AIDS Art Activism: A Conference on the

Culture of AIDS," March 10 through 12, 1989. This three-day conference will feature panels on AIDS, as well as theater, performance art, film and video, activism and cultural analysis, and will include presentations by Jan Grover, John Greyson, Douglas Crimp, Robert Atkins, Cindy Patton, ACT UP NY/LA, and many others. Seating for the conference is limited and pre-registration is urged. To pre-register, call the University Gallery at 614-292-0330.

The NAMES Project Quilt will be displayed at the Ohio State University March 30 through April 2, at a location yet to be announced. Sponsored by University Gallery in cooperation with the University's AIDS Education Committee and the Columbus AIDS Task Force, this four-day visit will mark the first time that the Quilt has been exhibited on a college campus. The locations and hours of the Quilt can be obtained by calling 614-292-0330.

These programs are funded in part by grants from the Ohio Arts Council's New Works Program in the Ohio Humanities Council.

For additional information regarding the exhibition, conference, and the Quilt, please call the University Gallery at 614-292-0330. ▼

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study and is administered in the same way, but contains no active ingredients. In other words, it contains zero dosage of the drug under study. In contrast to the control group, the experimental group is given the drug. Sometimes there are two or more experimental groups in a study, who receive different level dosages of the drug. This is done to determine the dosage at which the drug may work, and what harmful side effects may be caused by the drug at different dosages. In an uncontrolled study, everyone receives the drug.

Usually people in a controlled study will be assigned by a random selection process to the control and experimental groups. Such studies are called randomized studies. In a blinded study, the subjects will not know whether they are getting the drug or the placebo. In a double-blinded study, neither the subjects nor the researchers giving the treatment will know who is in which group.

The use of placebos has created tremendous controversy. Of central concern has been the ethical issue of asking PWAS with life-threatening conditions to undergo possible non-treatment. The controversy around use of placebos will be explored in a future column. Here it should be noted that trials may include provisions which attempt to minimize this problem. Some trials include a crossover, whereby the control and experimental groups shift treatments after a time, thereby spreading out the risk to all subjects. Others may interrupt treatment if a subject's condition worsens, and/or make provisions for other treatments.

These are the central aspects of a clinical trial's protocol. Understanding them is important for an individual considering participation in what might be described as a "randomized doubleblind, placebo controlled study." A phrase like this describes a study which assigns subjects at random to two or more groups, one of which will be given a placebo and the other(s) the drug under study; neither the subjects nor the researchers giving the drug will know who is in which group.

Protocols will also usually vary with the phase of a clinical trial. Clinical trials usually have three phases. Phase I measures how a drug works in the body and a drug's toxic effects;

these are usually uncontrolled (no placebos), small in size and short term in length. Phase II determines if the drug actually works and what short-term side effects are caused by the drug. These are usually double-blind with placebo. Phase III trials search for the most effective dosage of a drug that passes Phase II. ("Effective" means a dosage that will work and cause the least side-effects.) These are usually larger and longer-term trials (sometimes lasting years), which usually involve placebos. They often are multicenter studies, occurring in several places at the same time.

Only you can decide whether to participate. To make an informed decision, however, you should ask about anything which seems unclear to you. Here are some questions you might consider. What are the goals and the duration of the study? What is known about the impact and the side-effects of the drug under study? Am I required to stop other treatments I may be taking, or refuse other treatments that may become available, while I am in the study? Does the study use a placebo? If so, is there a crossover? Will treatment be interrupted if my condition worsens? In such a case, are there provisions for other treatment(s)? Will continued treatment be available after the study's conclusion? (People whose condition improves during the study sometimes experience a "rebound effect," in which their condition deteriorates when treatment stops. Access to continued treatment can be important.)

As with every other aspect of the HIV epidemic, issues of confidentiality and anonymity should be clearly outlined in a study's protocol. What are the confidentiality guidelines for the study? How will my identity and HIV status be recorded? Who will have access to my records?

Future columns will discuss treatment options for people who do not have access to a clinical trial, as well as the debate around trial protocols and the FDA drug-approval process.

Information for this column came from Treatment Issues, AIDS Treatment News, and PI Perspective. These and other publications on experimental treatments can be consulted at the Taskforce office.▼

Major New AIDS Study

Many people with AIDS and advanced ARC cannot tolerate full doses of AZT (zidovudine) because of problems with their blood counts. A large study has just begun to evaluate a new treatment program which may enhance the effectiveness of low-dose AZT in these AZT-sensitive people by adding an additional anti-viral drug to their lowdose AZT regimen.

For information about participating in this study please call toll-free

1-800-432-2828