Hiv Aids Clinical Trials

Currently, the FDA has approved over twenty medications for HIV antiretroviral therapy. However, because many researchers are still working to improve and advance treatment for HIV/AIDS, there are many ongoing HIV clinical trials in various stages of completion.

Of the 24 antiretroviral medications being tested, nearly half are in phase II/III of the clinical trial process. Prospects are a bit more grim in the vaccination category. In the search for an HIV/AIDS vaccine, only four of the seventeen possibilities have reached phase II/III of their clinical trials.

What to Expect in an HIV Clinical Trial

Clinical trials are a form of medical research that tests the effectiveness and safety of new drugs, vaccines and/or therapies. Researchers only begin clinical trials after thorough testing has been completed with lab animals. The testing process involves four phases:

  • Phase I: Researchers administer treatment to a small group to determine possible side effects. Healthy people not infected with the virus may participate at this stage.
  • Phase II: Testing is expanded to a larger group of patients to detect common short-term risks and side effects.
  • Phase III: Clinical trials are expanded to determine the overall risks versus benefits to evaluate whether the drug should be marketed for doctors to prescribe to their patients.
  • Phase IV: Final tests are run after the drug has been approved by the FDA and is on the market to assess optimal use procedures and any further risks.

Throughout the first three phases, patients involved in the clinical trial are generally divided into at least two different groups: one group receives the new medication while the other receives either a placebo (sugar pill) or the standard treatment. Those participating are not told which they receive and are, instead, only asked to report improvements or complications in their condition.

Individual HIV clinical trials vary in length and eligibility requirements depending on the focus of the study. While some last only a single year, others may not provide a clear ending date. Although those looking for adult participants require prospective candidates to be at least eighteen, studies vary on the other required aspects of the individuals, such as gender or sexual orientation.

However, there are some general elements that characterize HIV clinical trials. Studies tend to last at least one year and involve regular blood and/or urine tests to assess the effectiveness of the trial medication. HIV clinical trials also offer the opportunity to get free medical care and usually pay a stipend for your participation.

Participating in an HIV Clinical Trial

If you qualify for a clinical trial and choose to participate, researchers will contact you via mail, phone and/or email. As part of the initial screening process, you will be asked to provide your comprehensive medical history in order to evaluate whether you fit the clinical trial’s protocol. If you have the required profile, medical researchers will then contact you again to enroll you as a clinical trial participant.