Interpreting the results of HIV prevention trials (2) ......

Clinical Trial Results Are Valuable. This is because:
1. They can tell us which products are not studying anymore

2. They can point to the kinds of changes that could be made to
improve other clinical trial design

3. They may yield beneficial information about behavioral and
cultural practices that affect HIV transmission and the results we
get from clinical trials; and

4. They provide valuable information about how prevention trials can
be better managed.

Understanding Clinical Trial Results:
Prior to a clinical trial, studies of the product to be tested are
done in the lab and in animals. Small size, medium size and large
size animals are used when testing the product. the right animal is
also used. For example, when testing microbicides, the rabbit
vaginal is used because this is the most sensitive vaginal and if it
does not harm the rabbit vaginal, it may not harm the human vagina.
Doing a microbicide animal study using a donkey may therefore be

After animal studies, there are also other phases of studies:
1. Phase I which looks at the safety of the product or drug in very
few people

2. Phase II which looks at the safety of the drug and also tries to
test if the drug can do what it is meant to do in an ideal
condition. This is known as an 'efficacy' study

3. Phase III which looks at the safety of the drug and also tries to
see if the drug or product can do what it is meant to do under
normal conditions

Eg - Ampicillin is an antibiotics that went through animal, phase I,
II and III clinical trials. It was found to be able to treat similar
human infections in animals. It was found safe in phase I studies.
In phase II studies, It was shown to produce good results when taken
every 6 hours for 7 days. In phase III studies, it was shown that if
people miss the every 6 hours once in a while, or use it for less
than 7 days (for 3-5 days) it can still be effective. For this
reasons, the drug went throuh further development.

What is a successful clinical trial:
A clinical trial could end in any of the phases. A phase III trial
could be end because:

1. There is proof that the product can work to prevent HIV infection
e.g. male circumcision

2. That there is no proof that th drug is working e.g. carraguard

3. That the product or drug is causing harm eg making people very
sick or causing more HIV infectione.g. N9

4. When the results are not clear and there is no evidence that it
would be clearer with ontinued study e.g. SAVVY

An HIv prevention Clinical Trial would be considerd Successful if:

1. The research plan is conducted as stated in the study protocol.

2. The study is done using the right method

3. The trial provides further information to the HIV prevention field

4. Trial participants are informed and educated about HIV, the
purpose and outcome of the study.

5. The health of participants is protected

6. Trial is continuously monitored at defined intervals by the right
persons who know what they should be looking out for

7. Participants and the community are engaged with the research
process in an ethical, respectful and efficient manner.

8. The trial participants did not abscond from the trial and so at
least 85% of those that started the trial stayed till the end. This
reduces bias

9. The study results are communicated to participants, their
communities and other stakeholders.

10. A plan to ensure trial participants and or the study community
has access to study products in the case of a positive result.

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