NAPWA

Doctor Louise answers readers’ questions.

Where does my blood go?

Paris from Tweed Heads writes:I was part of an HIV clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. last year and signed a permission form for them to use samples of my blood for research. It got me thinking about all the blood I’ve given over the years and wondering what they do with it, whether my name is attached and who can get hold of the information.

Dr Louise replies:
Thanks for this question, Paris.

ClinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trials are a really important part of medical research. They help us develop new treatments and extend our clinical knowledge about how different treatments affect different people. We wouldn’t know everything we do today without the generous participation of people like you.

There are different possible uses for blood samples taken for the purposes of research.

Any study for which you donate a blood sample will have you sign a consent form. This form has a section that explains how your samples will be used – the type of tests including which laboratory is used, whether they’ll perform genetic testing as well as how the samples will be stored and for how long.

Some studies destroy the samples once the study is completed and others will ask if you agree for the sample to be used in similar research.

All study samples, once taken, are coded by a protocolA study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment -assigned number and laboratory number. This number cannot directly expose your identity as your name is not used. All data obtained is treated as absolutely confidential. Only the investigatorA medical researcher in charge of carrying out a clinical trial's protocol./study coordinator holds the link to the identification of your study number and name. This information is stored in your research file in a secure office in the research unit of the clinic where you receive your medical care. This data is not given to staff involved in testing the samples.

Remember, you are always able to contact the research team at anytime and ask them about your samples if you have any concerns.

Thanks to Dr Julian Elliot and Janine Roney, researchers at The Alfred Hospital, for their assistance with this reply.

Overtreated?

Stuart from Surry Hills writes: I’ve been on a number of different drug regimens over the years but never seem to find one that doesn’t cause something (diarrhoea, nausea, high lipids). My viral loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma. is constantly undetectable and I have a really good T cell count (800+). To tell you the truth I feel like I’m being over treated. I’ve read in your magazine and heard a bit about lower doses of HIV drugs working just as well as the doses currently being prescribed. Is it worth me trying these lower doses?

Dr Louise replies:
Thanks for your enquiry, Stuart.

It is reassuring to hear that your viral load is undetectable and that your CD4 count is very high. You have what we call ‘excellent virological control’.

As HIV doctors, we’re constantly trying to find regimes for people that control their virusA small infective organism which is incapable of reproducing outside a host cell., on the one hand, but don’t cause side effects, on the other (keeping in mind that some side effects may be short term, others ongoing, while some become apparent only after some time being on the medications).

The main aim of treatment is to achieve virological control to reduce the well-known sequelæ* of untreated HIV infection. If doses of the antiretroviralsA medication or other substance which is active against retroviruses such as HIV. are too low, then virological control may not occur and there is a potential for resistanceHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. to occur.

The doses of medications that we currently recommend are based on rigorous clinical trials. Their goal is to achieve drug concentrations that are effective to control viral replication.

We do reduce drug doses in some cases where there is renal or liverA large organ, located in the upper right abdomen, which assists in digestion by metabolising carbohydrates, fats and proteins, stores vitamins and minerals, produces amino acids, bile and cholesterol, and removes toxins from the blood. impairment. And therapeutic drug monitoring is available for some medications but it is not routine practice at this time.

In your case, I would suggest reviewing your medication regime with your doctor and look to see if there may be any alternatives or treatments for the side effects.

This is an ongoing issue for many people.

*Sequelæ refer to the negative after-effects of a condition.

ASK DOCTOR LOUISE

Keep your questions under 100 words and email them to pl@napwa.org.au.

Dr Louise Owen is Clinical Director of the Centre Clinic in St Kilda. Her advice is not meant to replace or refute any advice given by your own doctor as your individual medical circumstances are best dealt with by your own practitioner.

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