By Jaime

A clinical trial is a scientifically designed and executed investigation of the effects of a drug (or vaccine), administered to human subjects. The goal of a clinical trial is to define the safety, clinical efficacy, and pharmacological effects (including toxicity, side effects, incompatibility, and/or interactions) of the drug. Many shy away from clinical trials because outcomes are unpredictable—you may get the medicine or not; and if you get it, it may help you, have no effect, or harm you. Thus, there are pros and cons to clinical trials. Trials typically include a variety of ethnic groups and both men and women of different ages so that researchers can study the drug's effects and reactions in different people.

In a clinical trial, a person may receive either the actual drug or vaccine being tested or a placebo. A placebo is an inactive substance that looks like the real medication; a placebo allows the researchers to test the drug for efficacy and safety by comparing it to reactions in people who are not taking the drug, but think they are. This type of investigation—using a placebo—is called "placebo controlled study". The results obtained from such trials are then compared to see if the investigated treatment is more effective than the placebo. People taking part in placebo controlled clinical trials do not know that whether they are receiving the placebo or the actual drug or vaccine. Often, even the staff that checks volunteers doesn't know which individuals are getting the placebo and which are getting the actual drug or vaccine.

If you are participating in a clinical trial, remember that you may be in the placebo group. In the case of a drug trial involving HIV-positive individuals, it is important to remember you may not benefit from the drug being tested in the trial because you are getting the placebo. Even if you are receiving the tested drug, you may not benefit if it turns out to be ineffective. If you are participating in an HIV vaccine trial for HIV-negative individuals, it is important to remember that you may not be receiving the tested drug but a placebo. Maintain safer sex behaviors and don't assume that the trial will afford you any protection. Remember, there is usually a good chance that you are in a placebo group.

Many people living with HIV or AIDS participate in clinical trials as a way of supporting a search for the cure. Since people living with HIV or AIDS may have a depressed immune system, participation in clinical trials might have positive and negative effects for them. Some trial drugs could injure major organs and systems, especially in people whose immune system has already been damaged. Sometimes, the HIV-positive person may receive a placebo and miss out on the earliest opportunity to receive a new, effective drug. On the other hand, sometimes the participant may receive a drug that has a positive effect on his/her health. Regardless of whether HIV-positive people receive a placebo or a trial drug, regardless of whether they are helped or not, many people infected with HIV or AIDS are determined to participate in the fight to find a cure.

In conclusion, clinical trials always offer a mixed bag. Living with HIV or AIDS is difficult. Living with the fear of HIV infection is also difficult. The participant chooses to be involved in clinical trials, usually out of a desire to help in the fight. Yet, there is always some risk attached to taking trial drugs or trial vaccines. Researchers have made progress, in searches both for a cure and for a preventive vaccine. None of this progress would have been possible without the courageous participation in clinical trials of caring, concerned people. Hopefully, each new trial brings us closer to defeating this epidemic.