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When people hear about clinical trials, many right away think of participants serving as guinea pigs, taking experimental drugs that do God knows what.
The reality is much more positive. For example, many clinical trials for HIV do not use experimental drugs at all. Why? There are so many drugs on the market, the goal is to compare them head-to-head. Or doctors are looking for the best treatment strategies to use with the drugs now on the market. Trials can also have interesting benefits. One study provides an extremely expensive drug to people with HIV to see if it helps with their excess body fat. One study gave out palm pilots to keep track of side effects—I don’t know if they asked for the palm pilots back! Some studies do nothing more than collect one or two blood samples. Others don’t involve study participants at all—researchers simply look at patient records, with the patient names blotted out.
Even these studies, however, can be risky or inconvenient. Free medications and lab tests are nice, but require a certain number of visits, at a set amount of time (every four months, for example). Drugs being studied may not work for you. Still, it’s a shame that more people don’t realize how helpful and beneficial a study can be for them. On the following pages are some trials to think about. As Dr. Harold Kessler of Rush University Medical Center in Chicago said when he spoke at Test Positive Aware Network recently, “It’s the clinical trials that develop the drugs which save lives.”
Things to think about
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All the information you need is not listed here due to lack of space. For more information, contact the study coordinator. You will be asked if you meet the inclusion criteria (such as a certain number of T-cells) or have exclusion criteria (for example, viral hepatitis).
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You might prefer a study being funded by a pharmaceutical company because they often pay compensation. You might, however, still qualify for other studies—ask your trial provider about joining a government-sponsored trial. It’s for a good cause!
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Speaking of which, clinical trial networks are pretty good at continuing a person’s experimental medicine for free after a trial is over. Many of them can assign a social worker who can help set this up. Ask ahead of time what will happen if a medicine works for you, but the trial ends.
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If you do not qualify for a trial you’re interested in, ask that you be kept in mind for future studies.
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Remember, you can drop out of the trial at any time (but do try your best to stick it out!).
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Take it from the ACTG clinical trial website: “To ensure reliable results, clinical trials follow precise medical guidelines or research plans called protocols. If you choose to participate, you accept the responsibility to observe these guidelines. So before you decide, make sure you know the number and length of appointments, medical tests required, and other medications allowed. You will need to commit the time required for the study and travel to your appointments. Although you can leave a clinical trial at any time, do not start one if you think you may drop out.”
Trials to think about
For the study site nearest you, call 1-800-TRIALS-A (1-800-874-2572). Also call the AIDS Treatment Information Service at 1-800-HIV-0440 (1-800-448-0440). For HIV vaccine trials conducted by NIAID (National Institute of Allergies and Infectious Diseases), call 1-866-833-LIFE (1-866-833-5433). For studies beginning with the letter A, ask for the nearest AIDS Clinical Trial Unit (of the ACTG).
Experimental meds BAY 50-4798 is an IL-2 analog, meaning that it’s similar to IL-2; however, it has less toxicity. IL-2 is an injection drug used to increase T-cells. This Phase I/II study gives twice daily subcutaneous injections of BAY 50-4798 in-house (participants must spend a week in the hospital). In the Chicago area, call Janet Rindels at 1-312-942-5000, extension 21954.
Tipranavir
Boehringer Ingelheim in April expanded the Open Label Safety Study (OLSS) of its experimental protease inhibitor drug, tipranavir. The drug is boosted with a mini-dose of 200 mg Norvir. To qualify, people must have less than 100 T-cells and be unable to form a viable drug regimen from currently available drugs, or not qualified to join a current trial with tipranavir (now in advanced Phase III study). Side effects include diarrhea, nausea, vomiting and abdominal pain, fatigue, headache and dizziness. Tipranavir might be approved by the U.S. Food and Drug Administration (FDA) next year. For sites near you, call 1-800-632-2464 or visit www.clinicaltrials.gov.
Genetics
Earlier this year, ACTG researchers reported that genetics cause some people to clear Sustiva out of their body more slowly, leading to a greater risk of side effects. Moreover, this particular genetic finding was more common in African Americans than in whites. Analyzing blood samples for genetic differences is a new field, and there’s much work to be done. These trials often work off blood samples stored through a previous clinical trial, so you may not be able to just go in and have your genetics tested. ACTG—If you have ever been in an ACTG trial, please contact them if you’re willing to let them put your bloodwork into a genetic database. Fabulous! The database study number is A5128. (No, they can’t do it without your consent, so please call!) You will need to go in and give one tube of blood.
Hepatitis A5127 will see if people co-infected with hepatitis B will have a good response with two currently approved hep B drugs: Hepsera (adefovir dipivoxil) and Viread (tenofovir disoproxil fumarate). (Viread is also an HIV drug.) First one drug plus a placebo of the other drug will be tested, and then the drugs will be switched if your hepatitis doesn’t respond to treatment.
Managing side effects Prosaptide is an experimental, subcutaneous injectable drug for peripheral neuropathy (PN). PN is nerve damage that is a side effect of HIV and its treatment, which is often painful and debilitating. Prosaptide has been shown in early study to effectively treat pain in diabetics with PN with little side effects. It is also hoped that prosaptide will be able to regenerate nerve endings, not just treat pain. This is a pharmaceutical company sponsored trial, so there is financial compensation. The study is conducted with the Neurological AIDS Research Consortium (NARC). Visit www.centerwatch.com/patient/trials.html for a study site near you. Enter study number 2979 under keyword “Clinical Trials Search.” Check for new sites on a regular basis.
Serostim (recombinant human growth hormone) is in Phase III study for the use of reversing the fat accumulating on the stomach. This is called the HARS study, for HIV-associated Adipose Redistribution Syndrome. “Adipose” refers to fatty tissue. The incredibly expensive Serostim has long been popular for melting stomach fat in people with HIV, but it can cause carpal tunnel syndrome and edema (severe water retention), among other side effects. See ACTG. In the Chicago area, call Kris Richards at 1-312-942-5000, extension 29156.
Monotherapy Abbott M03-613 starts people who’ve never been on HIV therapy with a triple drug combination and then drops two of the drugs. This strategy is called “induction/maintenance.” It has been unsuccessful in the past, but this study uses a powerful drug that’s relatively new, Kaletra. Moreover, drug resistance is practically non-existent with Kaletra.
Abbott Laboratories is pharmaceutical non grata in the HIV community because of its announcement late last year that it was increasing the price of one of its HIV drugs by 400%. Nevertheless, this trial is exciting because of recent small studies finding outstanding therapy with Kaletra alone (monotherapy). Abbott M03-613 starts people off on Kaletra and Combivir, and then switches to Kaletra monotherapy after three undetectable viral load values (less than 50) after the first three months. A second group of people will be given Sustiva and Combivir, one of the most popular HIV regimens in the country. In the Chicago area, call Kris Richards at 1-312-942-5000, extension 29156.
Newly infected These are among the hardest trials to fill, as you can imagine. First people need to know that they’ve been recently infected with HIV (usually within the past six months), and then they need the presence of mind to seek medical care, much less a trial. Please know that these studies exist! Spread the word. Among other things, these trials may look at the amount of virus in the tissues and reservoirs (where HIV “hides out”) as well as the blood. They might also look at such things as strategies for managing acute (recent) infection. Call for AIEDRP (Acute HIV Infection and Early Disease Research Program). According to the AIEDRP website, “Scientists believe that events occurring during acute and early infection may determine the ultimate course of disease in an individual.” The ACTG is developing three new trials with AIEDRP.
SMART trial
This ambitious study follows thousands of people for more than five years. It tries to answer the question of whether to save therapy until T-cells are lower. (Medications are not provided.)
People will be randomly put into one of two groups. The first will stay on standard of care therapy. The second would be put on therapy when their T-cells drop to 250, and then taken off again when their T-cells go up to 350.
SMART stands for Strategies for Management of Anti-Retroviral Therapy. Call for The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). In the Chicago area, call Ed Goodwin at 1-773-244-5804.
Therapeutic drug monitoring (TDM)
TDM measures the amount of drugs in your blood. It should help prevent treatment failure by finding that drug levels are either too high or too low for your body. TDM is not commonly used in the United States, although it is commercially available. TDM is more widely used in Europe for HIV care.
ACTG 5146 will see if TDM can help therapy succeed for people with low drug levels of a protease inhibitor. The study will work with your doctor to help determine your therapy, but will not provide medications. It will provide TDM and phenotype resistance testing on your virus. This is great for people with low levels of a protease inhibitor, but not so great for the other folks, who will only be followed as a comparison group.
Also, not everyone with a low level will get TDM; some will only be recommended a standard of care drug combination based on the results of their phenotype resistance test. (This is a help, however, because test results are hard to understand and doctors will appreciate getting an expert opinion.) You must be on least your second drug combination, with a viral load of 2,000 or more.
Vaccines Ironically, one of the best things you can do for AIDS research is to sign up your HIV-negative friends and relatives. That’s because they can help you in the search for an HIV vaccine—but these studies require thousands and thousands of more people than the average trial that brings a drug to market! There are two different types of HIV vaccines—one to prevent infection in HIV-negative people and another to prevent disease progression in people who already have it. ADVax is being tested in HIV-negative people by the Aaron Diamond AIDS Research Center (ADARC) and Rockefeller University in the New York City and Rochester areas. It uses synthetic DNA, containing only portions of genetic material, and cannot cause HIV infection. ADARC Director Dr. David Ho said that, “Each day, progress is being made in the search for an HIV vaccine thanks to continued community involvement in HIV vaccine research.” The Center declared that a preventive vaccine is the world’s best hope to stop HIV, and most doctors agree. Study participants must be between the ages of 18 and 45, and be at low risk for HIV (they check the vaccine’s effect in test tubes of people’s blood). Contact Elizabeth Londoño at 1-212-448-5126 or e-mail aidsvaccine@adarc.org.
Websites to check http://hivinsite.ucsf.edu—from the University of California at San Francisco. This is a very useful site, especially for a list of studies. Don’t use “www.” Type “TrialScope” (one word) in the website’s search function.
www.aidsinfo.nih.gov has information in Spanish as well. You can also go directly to www.clinicaltrials.gov. The site has a complete listing of HIV clinical trial networks funded by the National Institute of Allergies and Infectious Diseases (NIAID). These are:
- Acute HIV Infection and Early Disease Research Program (AIEDRP)
- Adult AIDS Clinical Trials Group (AACTG)
- Centers for AIDS Research (CFARs)
- Comprehensive International Program of Research on AIDS (CIPRA)
- Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT)
- HIV Prevention Trials Network (HPTN)
- HIV Vaccine Trials Network (HVTN)
- Pediatric AIDS Clinical Trials Group (PACTG)
- The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA)
- The Women and Infants Transmission Study (WITS)
- Women’s Interagency HIV Study (WIHS)
- Multicenter AIDS Cohort Study (MACS)
www.acria.org is the site of the AIDS Community Research Initiative of America, and lists the organization’s trials, available in the New York City area. Information about the studies is easy-to-read.
www.aidsmeds.com is a highly readable and comprehensive site. Among its forums is one for clinical trials.
Trial networks not listed here include Bastyr University AIDS Research Center (alternative medicines); the HIV Epidemiology Research Study (HERS); the Studies of Ocular Complications of AIDS (SOCA); the U.S. Military HIV Research Program (international) and the AIDS Malignancy Consortium. |
