Glossary
Antiretroviral
A substance that stops or suppresses the activity
of a retrovirus such as HIV. AZT, ddC and ddI are
examples of antiretroviral drugs.
Clinical Trial
A test of a new or experimental drug in people. Also
called drug trials or studies.
Comparison trial
A trial in which experimental drugs are tested against
each other or against an approved drug.
Controlled trials
Trials in which one group gets the experimental drug
and another group gets either a placebo or an approved
drug as part of the control group of the study.
Dose comparison
A trial that uses different amounts of the same drug.
Sometimes the drug is tested against a placebo.
Dose escalation
In this type of trial a few people take a small amount
of the drug. If it doesn't hurt them, a few more take
a larger amount. This continues until the researchers
find the largest amount of the drug that can be taken
without immediate harm.
Double-blind
A type of clinical trial in which people are divided
into different groups. One group takes the experimental
drug and other groups take different doses, the standard
therapy, or a placebo. Neither the researchers nor
the people in the trial know who is taking what until
the trial is over.
Expanded Access
Programs designed to make experimental drugs available
on a wide basis to people who do not qualify for the
clinical trials or who live too far from a trial site.
HAART
Highly active antiretroviral therapy. Refers to a
combination of anti-HIV drugs.
IND - Investigational
New Drug
This
is the name given to an experimental drug after the
FDA agrees that it can be tested in people.
Informed Consent
The name given to the process during which a person
weighs the known and possible risks and benefits of
a trial, then agrees voluntarily to participate. When
someone agrees to be in a trial, they sign an agreement
called an Informed Consent Form.
Inclusion/Exclusion Criteria
The medical or other reasons why a person may or may
not be allowed to enter a trial. For example, some
trials do not allow pregnant women to join, others
do not allow people to take certain drugs, and others
exclude people with certain illnesses.
IRB - Institutional Review
Board.
Every institution or hospital that conducts research
involving human subjects must have an IRB that approves
and periodically reviews the research. The IRB protect
the rights of the people in the trial, determines
who can participate in the trial, and whether the
trial is ethical.
Naive
If you haven't taken any HIV treatments before, you
are said to be treatment naive.
Open-label Trial
A type of clinical trial in which researchers and
participants know who is taking the experimental drug
or the
treatment being given.
Placebo
A substance that has no effect on the body that is
given to onegroup in a placebo-controlled trial. Often
referred to
as a sugar pill.
Protocol
A detailed plan stating a clinical trial's purpose,
drug dosages, length of treatment, how the drug is
given, and inclusion/exclusion criteria.
Randomized Trial
A trial in which people are assigned to one of two
or more treatments by chance. Usually a computer is
used to be sure that everyone has the same chance
of getting on any given part of the trial.
Salvage Trial
a clinical trial, often open-label, for people who
have failed several many different approved HIV treatment
combinations.
Side Effects
All prescription drugs can sometimes have unwanted
effects, known as side effects. Laboratory testing
(bloodwork) is one of the methods used to monitor
for potential side effects.
Toxicity
Describes some of the possible side effects of a drug.
Also indicates how much of a drug can safely be taken.
Treatment Experienced
If you have taken some or many different HIV drugs
treatments, you are said to be treatment experienced.
If you're
doing well with what you're on, you are stable.
Treatment IND
An FDA program that makes experimental drugs available
to seriously ill people. Drug companies may charge
for the
drug, although most don't.
Undetectable
means the amount of HIV in the blood sample is too
low to be measured, but it doesn't mean that there
is no HIV
there at all.
Viral Load Test
The viral load test measures the amount of HIV in
a blood sample.
