T-20 expanded access study announced

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Roche have announced plans for widening access to their experimental fusion inhibitor, T-20 (pentafuside), a new type of anti-HIV treatment. A worldwide open-label safety study, codenamed T-20 305, is due to begin sometime between January and April of next year.

T-20 has been trailed as an important new treatment option for people whose prior experience of other available agents leaves them with few other choices. Studies so far have indicated that the inclusion of T-20 in ‘salvage’ regimens for people with multiple class experience improves the virological response to the new combination compared to switching to a regimen that does not include T-20 (click here for further information on T-20).

The drug is difficult to manufacture, however, and supplies of the drug have therefore been very limited. Roche now say that, in addition to ongoing clinical trials, 450 people will gain access to T-20 via an open-label study next year. The study will recruit in the UK, Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, Switzerland, North America, and Brazil. Participating centres are expected to be those which took part in an earlier T-20 study, codenamed T-20 302.

Glossary

open-label

A clinical trial where both the researcher and participants know who is taking the experimental treatment. 

salvage therapy

Any treatment regimen used after a number of earlier regimens have failed. People with HIV who have experienced side-effects and/or developed resistance to many HIV drugs receive salvage therapy, sometimes consisting of a large number of medications.

fusion inhibitor

Anti-HIV drug targeting the point where HIV locks on to an immune cell.

AIDS defining condition

Any HIV-related illness included in the list of diagnostic criteria for AIDS, which in the presence of HIV infection result in an AIDS diagnosis. They include opportunistic infections and cancers that are life-threatening in a person with HIV.

Entry to the study is targeted at people on HAART who have had a CD4 count below 50 within the last 90 days. In addition, people who have had an AIDS-defining event in this period will be given first preference over those who have not. A quota of places on the study is allocated to each participating country based on the World Health Organisation’s HIV prevalence figures. However, we understand that the UK is to be allocated fifteen places.

T-20 is given by injection rather than as a tablet, and in common with all anti-HIV drugs, resistance to T-20 will emerge if the drug is taken without the support of other agents which are active against HIV.