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For the Physician
Research on new medicines and treatment regimens is key to improving the health care of people living with HIV/AIDS.
AIDS Community Health Center’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 AIDS Community Health Center:
- Early Access Trials: the FDA allows promising HIV/ AIDS drugs to be used before final approval. Early Access Drugs have been available at AIDS Community Health Center since the agency opened in 1989.
- Trials sponsored by the drug’s manufacturer: These phase IIIb or IV trials involve collecting additional information in larger numbers of patients outside of clinical trials on drugs that have been approved by the FDA.
- Government-Sponsored Clinical Trials
ACHC 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.
Many of the same trials being conducted at the University are also available on-site at AIDS Community Health Center.
A list of trials currently enrolling patients is shown below.
Head-to-Head vs. Placebo Trials
Most HIV clinical trials in the era of highly active antiretroviral therapy (HAART) do not have placebo treatments arms. Most clinical trials being conducted at AIDS Community Health Center today compare an HIV drug or drug combinations against one another.
If a trial involves the possibility of being randomized to placebo, this is discussed with the patient in advance.
The Clinical Trials Safety Net
The "Safety Net" for clinical trials includes:
IRB Approval. All AIDS Community Health Center 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 subjects first. All study subjects sign a consent form prior to participation.
Physician Oversight. AIDS Community Health Center physicians are an important part of the Safety Net. An AIDS Community Health Center physician oversees all clinical trials, and other physicians act as Principal or Co-principal investigators in each trial.
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