Services

Clinical Trials

Pill_Bottles_51_75.jpgResearch on new medicines and treatment regimens is key to improving the health care of people living with HIV/AIDS. Trillium Health’s clinical trials are open to all people with HIV/AIDS who meet the entry criteria for the trial, regardless of where they receive their HIV care.

Types of Clinical Trials
Several types of trials are currently being conducted at Trillium Health:

  • Early Access Trials: The FDA allows promising HIV/AIDS drugs to be used before final approval. Trillium Health has been selected to participate in many Early Access Trials since 1989, giving many patients expanded treatment options.
  • Pharmaceutical Company Sponsored Trials: These phase II, IIb, III, IIIb or IV trials involve collecting information on a newly developed drug/drugs by the sponsor. These trials may collect information on proper dose, drug-drug interactions or simply how well their drug works as compared to another company's drug.
  • Government-Sponsored Clinical Trials: Trillium Health is a part of the University of Rochester's Adult AIDS Clinical Trials Group (AACTG). The US AACTG is a program of the National Institutes of Health (NIH) and is the largest HIV clinical trials organization in the world.

Head-to-Head vs. Placebo Trials
Most HIV clinical trials in the era of highly active antiretroviral therapy (HAART) do not have placebo treatment arms. Most clinical trials being conducted at Trillium Health today compare an HIV drug or drug combinations against one another.

The Clinical Trials Safety Net includes:

  • IRB Approval: All Trillium Health clinical trials are reviewed and approved by an independent Institutional Review Board (IRB) prior to enrolling patients.
  • Informed Consent: The risks and benefits of the trial are explained to potential study participants first. All participants are required to sign a consent form.
  • Physician Oversight: Trillium Health medical providers are an important part of the Safety Net. A provider oversees all clinical trials as a Principal Investigator, and other providers act as Sub-investigators in each trial. A highly-trained, specialized research nurse is also available to work with patients in each trial.
  • Regulatory Oversight: An Trillium Health staff member with specialized training and experience ensures that all studies are conducted and reported in accordance with regulatory and legal requirements.

Have questions about participating? See our Clinical Trials FAQs

Internet Resources for Clinical Trials
American Foundation for AIDS Research (AMFAR)
The AIDS Community Research Initiative of America (ACRIA)
Adult AIDS Clinical Trials Group (ACTG)