How will I take the treatment being trialled? You may want to
ask how the treatment is given and how often; how it needs to be taken; and how
it will be provided.
How often will I have to visit the clinic? Make sure that the
schedule for clinic visits is explained to you so you can make a realistic
decision. Ask whether the trial is able to offer financial help with expenses
such as childcare and transport costs.
What will happen at these visits? Trial monitoring visits
will normally include blood tests, seeing a doctor, and an opportunity to
report any side-effects or problems you are having. Occasionally, a study may
require other tests such as scans, ultrasounds, or, on rare occasions, biopsy.
When will I get the results of blood tests? Some trials will give you
the results of viral load tests and CD4 counts right away, allowing you to
discuss options with your doctor if your viral load is not suppressed. However,
in other studies your doctor will decide when you should come off the trial
medication if you show signs of a poor response to your current treatment.
What other medications or drugs can I take while on
this trial? The trial protocol will
usually specify certain drugs that should not be taken in case they confuse the
outcomes of the trial. Ask for a full list of drugs (including over-the-counter
medicines for hay fever, headache or other everyday complaints, or recreational
drugs) that should be avoided.
Are there any restrictions relating to birth control
or pregnancy? Many trials require women
who could become pregnant to be using contraception. Most trials exclude
pregnant and breastfeeding women. Find out what you would have to do if you
thought that you had become pregnant while in the trial, and what is known about
the potential effects of the study medication on the unborn child.
What happens if my condition worsens? Many trials require you
to leave the trial if your condition worsens beyond a certain point. Some
trials guarantee that people who have been receiving a placebo will be switched
over to receive the genuine trial drug if their condition deteriorates.
How long will the study last? Trials can last any
length of time from a few weeks to years.
How will this trial affect my future treatment
options? Finding out how
resistance to a new anti-HIV drug develops is an important part of an HIV
treatment trial. Clear safeguards should be built into the design of the trial
to minimise the risk that you will develop resistance.
How will I be informed of the trial's results when it
ends? The researchers have a
duty to report on the results of the trial, whatever they show, and how they
contribute to existing knowledge.
How will other drugs taken during the trial be
chosen? Unless the trial is
specifically designed to recruit
only those people who have taken particular drugs in the past, you should be
offered the other HIV drugs you take alongside the trial drug in the way now
considered to be the standard of care – by resistance testing.
Would I be advised to start treatment now even if
this trial wasn’t taking place? Trials which recruit people with no previous treatment experience
fall into two categories:
- Primary infection (people infected within the past six
- Chronic infection (people who have been infected for longer).
If you are asked to join
a primary infection study, you might want to think about whether you are ready
to commit to long-term treatment at a time when you may still be adjusting to
living with HIV.
But if you join one of these studies, you will be helping to
answer very important questions.
Joining a trial after you
have been HIV-positive for a number of years will have different implications,
depending on how long you have known that you are HIV-positive, and your
overall state of health. If you have been diagnosed recently, you may also be getting
used to knowing about your HIV status and building a relationship with your