Being Alive Newsletter; July 1992
Mary Lucey and Nancy MacNeil

The largest number of trials in this country are being conducted by the AIDS Clinical Trials Group (ACTG). This is a federally funded network of some forty hospitals and universities around the country. In fact, the bulk of our federal AIDS research dollars goes into conducting ACTG trials.

THE PAST AND PRESENT SITUATION

Up until recently, clinical trial participants have been almost exclusively gay, white, middle class men. Some trials simply excluded women for reasons that can only be termed paternalistic. Researchers were concerned about possible pregnancy or with the need for child care. Other trials, while not actively excluding women, made no effort to bring us actively into the process.

This situation is now slowly changing. Researchers no longer write trials that intentionally exclude women. On the other hand, trials written exclusively for women focus on our fetuses or newborns, not on how HIV manifests itself specifically in women. Too often, we still see trials that are not open to women because they are structured along patient profiles that are profiles of men.

Attempts are being made to recruit more women for clinical trials. Even so, many women have not found the means to access these trials. For the past ten years, many gay, white, middle class men have learned to access the ACTG system to extend their lives. It is now time for women to find a way to make better use of this vital resource

Currently, there is more access to women than in fact is being used. Getting women to participate in trials, however, is a hard sell. Many women have fears about being experimented on, although most of these ACTG trials could not truly be termed experimental and are safe. The only way to make this treatment option more available to women is for HIV+ women to come forward and tell researchers what exactly is wrong with current trials and what obstacles are still preventing women from accessing ACTG trials. We also need to advocate for trials that are intentionally designed to provide treatment and therapies for women.

ADVANTAGES OF PARTICIPATING IN CLINICAL TRIALS

Some clinical trials offer women an opportunity to take advantage of the very latest developments in therapies and treatments. This is the chance to "get in on the ground floor." Other trials offer free drugs that have already shown promise. For many women, these trials provide access to therapy that they otherwise might not have.

Most drug trials include free medical care and monitoring. This free, often long term, health care is probably the most valuable benefit that a woman receives when participating in a clinical trial.

STAGES OF DRUG TESTING

There are three distinct stage of drug testing. Phase I trials happen very early on when researchers do not know much about the drug. Usually they do not know the right dose, or the optimum way to use the drug, or sometimes even how safe it might be.

Phase I trials are an experimental place to be. For women in search of basic health care, these trials should be avoided. On the other hand, we desperately need women to participate at this level or we will never have baseline data for women. We need to know how new drugs work on women, as well as how they work on men.

Phase II trials are used to refine the therapeutic uses of promising drugs. By this point, dosage and safety have generally been established. By Phase III, researchers have a good sense of a drug's therapeutic value and correct dosage. Most Phase III trials involve comparisons of drugs that have proven to be effective. Both Phase II and III trials are good opportunities for women in search of basic health care and monitoring.

FOR MORE INFORMATION

To find out what trials are going on throughout the country and what the criteria for joining are, you can call 1.800.TRIALS-A. You can also search through a copy of AMFAR's AIDS/HIV Treatment Directory or the Southern California HIV Treatment Directory. Both there publications are available at Being Alive's library in Silver Lake, at APLA's library in Hollywood, and at the West Hollywood Library's HIV Information Center.

SOME FINAL THOUGHTS

When deciding to participate in a clinical trial, there are serious choices to be made. Free health care, monitoring and drugs are going to come with some strings attached. Be sure that you fully understand what you are getting into. Do some homework to determine which trial will most benefit you. Read the consent documents closely. Be aggressive in asking questions and challenge the medical establishment in issues pertaining to women with HIV/AIDS. As women, we have the right to extend out lives and accessing these trials is one way of doing that.

(Mary Lucey and Nancy MacNeil are members of ACT UP/LA's Women's Caucus. They can be reached at the Being Alive office, 213.667.3262.)

920701
BA920712

Copyright © 1992 - Beings Alive. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. Subscription lists are kept confidential. Being Alive, 621 N. San Vicente Blvd., West Hollywood, CA 90069, Tel - 310.289.2551; FAX - 310.289.9866; Email: BeiAlive@aol.com  http://www.beingalivela.org/