Patient recruitment for drug trials at
The Diana, Princess of Wales HIV Research Unit,
Somerset Hospital

On-going patient screening is carried out at the HIV Research Unit to find subjects to participate in the pharmacokinetic trials. The screening process entails 5 stages:

1. A medical history is taken (when the patient was diagnosed with HIV; medical problems experienced because of the virus)
2. Stage of HIV/AIDS is identified
3. Safety laboratory test is completed
4. HIV viral load is established
5. CD4 count is taken

How patients qualify for a trial
Different eligibility criteria are set out for each trial by the pharmaceutical company that has designed the particular trial. To qualify for a trial, the patient must comply with the criteria for a given study. For example, a study may stipulate that the patient's viral load range be between 5 000 and 100 000.
Following a screening visit, patients who qualify for a drug trail are randomised and admitted onto a pharmacokinetic (PK) trial. This entails an admission to the ward for a variable period of time (depending on the trial). During this time, patients receive an experimental drug or experimental combination of therapies. Regular investigations are carried out during each trial to ascertain the safety and efficacy of the therapies being tested.

During the trial
Patients stay in a 28-bed ward during the course of the trial. Because the patients are not allowed to leave the ward during this period, the ward is geared to keeping patients as comfortable as possible. There is a recreational area where patients can watch DSTV, play table tennis or pool or listen to CDs. Patients are allowed to receive telephone calls, but can only make local calls from the ward. Following their discharge from the pharmacokinetic unit, patients participate in roll-over studies at the HIV/AIDS clinic which runs from Somerset Hospital.

What is expected of patients
Patients are expected to keep the HIV Research Unit informed of any medical events e.g. if any medication has been taken etc. Compliance is an important aspect of each drug trial.

At present, The Diana Princess of Wales HIV Research Unit is recruiting for the following trials:

Pharmacokinetic trial

1. New nucleoside drugs
2. Requires hospital admission
3. CD4 count more than 200
4. Viral load 5 000 – 100 000 cop/mL
5. Drug naive
6. Will be eligible for follow-up study of 4 –5 drug combination

Pharmacokinetic trial

1. Non nucleoside drug daily
2. Hospital admission
3. CD4 count more than 200
4. VL 10 000 – 1 million copies/mL
5. Drug naive
6. Follow-up study with study drug and AZT and 3TC

Phamacokinetic trial
New protease inhibitor: CD4 count more than 50, follow-up access to delavirdine, 3TC and AZT.

Should you know of a patient who may qualify for a trial, please call +27 (0)21 402-6393, fax +27 (0)21 425-2021 or e-mail here.

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