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Ask a Guinea Pig: What’s Involved in Cure Research—And Why Should I Participate?

, by Matt Sharp

HIV research has entered a new phase in order to find a cure. Clinical trials have traditionally sought to find treatments for people living with HIV, yet the new cure research will not necessarily seek to benefit the individual participant but find answers that will eventually lead to curing HIV on a global scale. So what’s in it for you?

In some cases, the trials may benefit individuals by boosting immune responses, for example. But at this stage of the process, there are many questions to be answered regarding safety and proving new concepts as the research moves forward. This may leave potential trial participants with a few questions of their own.

Why should I enter a cure clinical trial that may not benefit me?

In the coming months and years, cure research will depend on thousands of healthy,  HIV-positive trial participants. Volunteers will be needed to test new concepts, establish safety, and prove effectiveness. It is critical that each person weigh the risks and benefits of entering a cure research trial, as well as read and understand the informed consent document provided before trial entry.

There will most certainly be risks, especially in early-phase trials where participants may be asked to interrupt antiretroviral treatment or be required to provide tissue samples. In the end, however, your altruism will hopefully lead to a cure. The Merriam-Webster Dictionary defines altruism as “unselfish regard for or devotion to the welfare of others.” A good example of this kind of altruism is people who volunteer to enroll in vaccine trials, where a direct benefit may or may not be proven.

How risky are the trials?

Of course, this will depend on the trial. Early-phase trials are arguably the most risky, as they involve new technologies or strategies that have not been extensively tested with humans. Some of the new cure concepts involve cell or gene therapies, in which risks to individuals may not be known for a long time. So far, most of these concepts in HIV cure trials have proven safe.

Some drugs being studied in HIV eradication trials have been assessed in humans already, and safety has pretty much been established. However, each drug is different and risks must be weighed accordingly in terms of dosage and length of the treatment. Trials of drugs or procedures to improve the immune response may also be risky, as our immune systems operate in a delicate balance and any tinkering may cause short- or long-term harm.

This is why all U.S. clinical trials must be approved and monitored by an institutional review board (IRB) made up of clinicians, statisticians, and members of the community. Later-stage studies and large trials sponsored by the National Institutes of Health must also have a data safety monitoring board (DSMB) to watch for safety issues throughout the trial. Researchers also routinely check participants’ viral load, CD4 counts, and markers of general health during a study so that any safety issues are caught as quickly as possible.

How can I be fully informed of the risks and benefits of taking part in a cure trial?

Cure research may be much more complicated than typical drug studies and therefore more challenging to explain to the participant. Over the years, the informed consent document, which explains all the risks and benefits of the clinical trial, has become more extensive in order to protect the liability of the researchers and their institutions and/or companies. However, these changes have made informed consent documents more unwieldy for the participant. Researchers and community activists are currently working on ways to ensure participants fully understand the risks and benefits through a robust yet simpler informed consent process.

Don’t be afraid to ask questions or voice your concerns about the trial. If you are worried about a specific procedure or possible side effect, speak up! You are volunteering your time and maybe your blood, tissue, and cells, so don’t be shy about asking for more information from the research team.

Are participants paid for cure research?

Again, it is going to depend on the trial. Institutions have to be careful about offering large amounts of money for trial participation in order to avoid “coercion.” As is the standard in clinical trials in the past, reimbursement for time lost from work or for any invasive procedure (such as a biopsy) should be offered. Weigh these incentives carefully and think about what you are willing to give up to be in the trial. If you are unclear about the risks, talk to your doctor.

How can I learn about HIV cure trials recruiting in my area?

Clinicaltrials.gov is a searchable database of almost all clinical trials being run in the United States. It’s easy to search for trials, but you may have to know specific searchable terms, such as “eradication,” “functional cure,” or “gene therapy.” HIV should be added as a search term. You can also add your location in the search box to find trials in your area. There is also a “help” function on the site that can be useful.

 . . .

It’s a simple as this: Without participants enrolling in HIV cure trials, there will never be a cure. Remember that there are many systems in place—such as the institutional review boards, data safety monitoring boards, and the informed consent process—that protect the participants in clinical trials. No institution wants to harm participants.

Just because you sign an informed consent doesn’t mean you can’t leave the trial at any time, but try to head off any surprises that might cause you to exit a trial early. If a particular trial isn’t right for you, it’s better to know that before you start.

The most important thing is to ask questions and get answers from the research team or your own doctor about any concerns you have. You are working together toward a cure, after all.

Matt Sharp is a Person with AIDS, longtime HIV treatment advocate, and writer.

Further Resources

  • ClinicalTrials.gov: A searchable database of most U.S. clinical trials, with in-depth descriptions of each study.
  • HIVresource: This free quarterly newsletter from San Francisco AIDS Foundation links readers with HIV-related clinical trials in the San Francisco Bay Area.
  • Volunteering in a Clinical Trial: A user-friendly guide to participating in clinical research, from Centerwatch. Read it online or download and print the brochure to take along on your study visits.

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3 Responses to Ask a Guinea Pig: What’s Involved in Cure Research—And Why Should I Participate?

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