Why You Should Consider Being in an AHF Research Study

By taking part in clinical trials, you're not only helping yourself, you're helping others. Your participation helps us find new and better HIV treatments. Additionally, AHF Research offers many benefits for those who join our clinical trials:

• Access to the newest HIV medications
• Free regular medical exams by a physician
• Free medications for the length of the study
• Free laboratory work
• Complete confidentiality
• A transportation stipend ranging from $25-$40 for each scheduled completed visit

Current AHF Research Clinical Trials

Research FAQs

Q: Do I need to participate in a study in order to receive treatment?
A: No, you can and should discuss all of your treatment options with your regular medical provider before participating in a research study so that you understand all of your options.

Q: Once I am in a study, can I drop out?
A: Your participation in studies is purely voluntary. You can drop out at any time for any reason without penalty to you. In addition, if for any reason the physician conducting the research or your physician feel that the study is no longer beneficial or may even be harmful to you, they may take you off a study.

Q: Why should I participate in research?
A: You should participate in research if you would like to contribute to the scientific understanding of your illness. You or future generations may benefit from the contribution of your time and effort. In addition, you may have the first opportunity to receive the newest, cutting-edge therapies for your illness before they are available to the general public.

Q: Do I have any rights as a research subject?
A: Yes. Every research protocol is overseen by an Independent Review Board in order to protect patient safety. In addition, every research subject is given a copy of the Research Subject's Bill of Rights. Every study is subject to oversight by independent monitors from drug companies to the FDA. When you are in a study, you will receive a consent form that explains in detail the procedures of the study. You should fully understand the consent form before signing or participating in a study. You cannot be enrolled in a research study unless you give your signed consent. You can also drop out at any time.

Q: What are the pros and cons to participating in research?
A: The pros to participating are the opportunity to receive the newest, cutting edge therapies for your illness before they are available to the general public. In addition, you will have the benefit of being followed by additional specialists in the field of HIV/AIDS who will communicate your results to your regular medical provider. The cons to participating are that the treatments are new so there may be unforeseen side effects and risks. There is no guarantee of efficacy.

Q: Will I be a "guinea pig" if I participate in a research study?
A: No. As a research participant you have certain protections. All medications involved in research studies have undergone extensive laboratory and animal studies before they are administered to humans. In most cases, the medication you will be taking in a study has already been administered to other people in earlier studies.

Q: Why do you have to do research?
A: All medications in the United States must go through multiple phases of testing before they can be approved by the FDA. All the treatments currently available today by prescription have been tested on people who previously were willing to participate in research studies.

Q: Are there any guarantees?
A: No. There are no guarantees that you will have no side effects or that the study medication will work for you. However, if it appears that a medication is not right for you, the study investigator may discontinue you from the study.

Q: What do the stages in the drug approval process mean?
A: Every drug, before it is approved by the FDA, must undergo stepwise research. Not every promising drug compound makes it through all four stages. The timeline from conception to FDA approval can take many years due to the rigorous testing that each drug must receive before approval.

Clinical Research Stages

This table describes each of the stages in the clinical research process:

Preclinical Trials

Animal studies that support Phase I study and tolerance trials. Data about a drug's effects in animals help establish boundaries for safe use in human testing.

Phase I Trials

Initial safety trials on a new medication in which investigators attempt to establish a safe and effective dose and dosing regimen in about 20 to 80 healthy volunteers. This data provides the guidelines for larger safety and efficacy studies.

Phase II Trials

Phase 2a: Pilot clinical trials to evaluate efficacy and safety in selected populations of about 100 to 300 patients. These studies often involve hospitalized patients who can be closely monitored. Objectives may focus on dose-response, type of patient, frequency of dosing, or any number of other issues involved in safety and efficacy.

Phase 2b: Well-controlled trials to evaluate safety and efficacy in patients who have the disease or condition to be treated, diagnosed, or prevented. These trials usually represent the most rigorous demonstration of a medication's efficacy.

Phase III Trials

Phase 3a: Multi-center studies in population of perhaps 1,000 to 3,000 patients for whom the medication is eventually intended. Phase III trials generate additional safety and efficacy data from relatively large numbers of patients in both controlled and uncontrolled designs.

Phase 3b: Trials conducted after regulatory submission, but prior to FDA approval and launch. Such trials may supplement earlier trials, complete earlier trials, or may be directed towards a new type of trial (e.g. quality of life, marketing).

Phase IV Trials

Large-scale clinical studies performed after a medication has been approved by the FDA to test the medication in related indications and/or to generate additional efficacy and safety data to be included on the its label.