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Glossary of Terms

Clinical trial – A study of a medicine or disease in people.

Data – The information collected by researchers during a study to help better understand the study topic.

Dose-escalating – A dose-escalating study is done with new medicines to figure out how much of a medicine should be given to an individual. Dose-escalating means gradually increasing the amount of medicine until the correct amount is determined.

Double-blind or blinded – A blinded study is designed so that the participants do not know which treatment arm they are on. A double-blind study is one where neither the doctor nor the participant knows which treatment arm the participant is taking during the study.

Exclusion criteria – Factors that will prevent a person from participating in a specific study, either for the person’s safety or to make it easier to understand the study results. For example, someone might be excluded for having liver problems, or if that person has already used a drug that is being studied.

Inclusion criteria – Requirements that a participant must meet to participate in a specific study (such as T-cell count, viral load, age or other laboratory values).

Informed consent – A legal document that explains a course of treatment, the risks, benefits, and possible alternatives; the process by which patients agree to treatment.

Observational study – A study that observes participants and collects information about their medical history, but does not assign treatments or interfere with their health care.

Open-label – A study in which the participants know which treatment arms and medications they are on.

Placebo – A sugar pill that looks like the drug being studied, but does not contain medicine.

Placebo-controlled – A study that gives some people a placebo and some people a medicine so that the effect of the medicine can be compared to no treatment.

Protocol – A scientific plan that describes the reason for doing a study, how it will be done and the goals of the study.

Randomized – Assigned by chance or randomly, like tossing a coin. This refers to the way people are assigned to different arms of a study.

Study arm – An arm of a study is a specific treatment being studied and involves a group of people usually being compared to another group, or arm, of the study.

Treatment-experienced – A person who has already taken at least one antiretroviral medicine to treat his or her HIV disease.

Treatment-naïve – A person who has never taken antiretroviral medicines to treat his or her HIV disease.