ABT-538 IN COMBINATION TRIAL: London clinics to study new protease inhibitor in combination with AZT

ABT-538 IN COMBINATION TRIAL: London clinics to study new protease inhibitor in combination with AZT

AIDS TREATMENT UPDATE, Issue 28 - April 1995
Edward King

Researchers are preparing to begin a trial in London of a protease inhibitor that in early studies appears to be among the most promising of experimental anti-HIV treatments. Assuming that the study is approved this month by the Medicines Control Agency, the drug, which is produced by Abbott under the codename ABT-538, will be tested alone and in combination with AZT.

Like other protease inhibitors, ABT-538 works against the enzyme that HIV uses to break down large proteins into smaller ones, from which new virus particles can be made. Early trial results reported at the recent conferences in Glasgow and Washington found that people who took ABT-538 on its own experienced marked declines in levels of HIV in their blood and substantial increases in their CD4 counts. Side-effects were minimal, but included diarrhoea and tingling or numbness round the mouth.

TRIAL FOR AZT-NAIVE PEOPLE

The new trial will test ABT-538, on its own or in combination with AZT, and compare its effects with those of AZT alone. ABT-538 will be supplied in a liquid form that has to be stored in the fridge all the time. The trial will recruit people who have had no prior treatment; trials for people who have taken AZT before are expected to start in a few months' time.

Participants must have CD4 cell counts above 200. They will randomly assigned to take either:

- AZT alone (200 mg three times daily), or - ABT-538 alone (600 mg twice daily), or - the combination of ABT-538 plus AZT.

They will continue to take the trial treatment for 12 months, unless they develop an AIDS-defining illness.

People who develop an AIDS illness within 4 months of joining the trial will have the option of continuing in the study, but if they choose to stop then they will not be eligible to receive ABT-538 openly. People who develop an AIDS illness after they have been in the study will be able to withdraw from the trial and start to take ABT-538 openly. Everyone who completes 12 months in the trial will be eligible for open-label ABT-538.

The trial will assess the effects of the three regimes by monitoring changes in recipients' CD4 counts and in levels of HIV in their blood plasma and blood cells. Participants will have to visit the trial site every week for the first month, then every fortnight for a further 6 weeks, and then monthly for the rest of the trial.

In Britain, this study will recruit 12 participants at each of two London clinics - the Kobler Centre and the Royal Free Hospital.

Kobler Centre Chelsea & Westminster Hospital 369 Fulham Road London SW10 9NH Tel. 0181-746 8000

Contact Sandra Davies, bleep 0388

Royal Free Hospital Pond Street London NW3 2QG Tel. 0171-794 0500

Contact Deborah Farmer, bleep 660

9504
ATU2801

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