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Jun 14, 2006

my lover is going into a study for the tmc114 and tmc125. i'm asking if a placebo is no longer taking place in study drug testing. i was told by a nurse that they could no longer do a placebo tretment and that the person had to be given both drugs or one drug. I live in mass.if that makes a differents. thank you al

Response from Dr. Wohl

Placebos are used in certain types of studies and when they are the consent form indicates this clearly. For a treatment study of initial therapy for HIV infection or treatment following treatment failure, each regimen must have active drugs that are expected to work. If the study is between two regimens with different numbers of pills and is blinded (the participant and the investigator are unaware of what therapy the patient is taking) then placebos are used so as to not give away the treatment assignment.

In other studies, such as short term trials of new medications, some people may be assigned to only placebo and not active drug. This is justified by the short duration of the study (weeks) and the inclusion of people who are fairly healthy. Again, the placebo part is included in the consent document.

So, placebos are used. They can help determine that any adverse effects seen can be compared with those seen in people not on active drug - an important thing to do so as not to label a drug as having a side effect (e.g. anemia) when that 'side effect' was also seen in people assigned the sugar pill.

When considering any study, read the consent carefully. Take it home. Write down questions and take these to your doctor and the study staff. That way there are no surprises.


Kaletra Monotherapy
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