NAPWA

A groundbreaking study underway in Melbourne aims to show that a potential new HIV treatment is able to do what current antiretroviralsA medication or other substance which is active against retroviruses such as HIV. cannot: eradicate HIV from latently infected cells.

Present treatment regimens are very effective in targeting the HIV circulating freely in blood. However, they are unable to get at viral reservoirs — cells in places such as the gastrointestinal tract, the brain and the genital tract — which harbour HIV DNA.

The virus persisting in these dormant ‘memory cells’ is just a tiny percentage of all HIV in the body, but it is the reason people generally have viral rebound when they stop treatment.

The study, led by Melbourne-based researcher Professor Sharon Lewin, aims to establish whether vorinostat — an agent currently used for treating a form of cancer — is able to act on these latently-infected cells, causing them to express the HIV they hold within. Theoretically, if a drug were able to ‘switch on’ these cells, they would start to produce virus and die, and the infection of further cells would then be prevented by HIV antiretrovirals. Hence, this has been seen as a potential step towards the goal of eradicating HIV from the body.

This is a small proof-of-concept study, recruitingThe act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process. through The Alfred Hospital in Melbourne, with the limited aim of determining whether or not vorinostat increases the frequency of HIV RNA expression in latently-infected cells. It will involve just 20 patients in this phase.

Professor Lewin told an information night hosted by NAPWA in Melbourne in July that after 14 days the first patient treated in the study had experienced some side effects, including nausea and loss of appetite. This had not prevented him from continuing to work, and had resolved when they stopped the treatment.

Because vorinostat is already licensed for treating cancer, there is good clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. experience and safety data. However, its use in HIV is still experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval., and Professor Lewin noted that there are a number of important questions about the drug which would need to be answered if it proves to be able to activate latent HIV in human trials.

Do all the genesThe most basic unit of genetic information. return to a normal state of regulation following treatment with vorinostat?

Are there other unknown long-term side effects?

In the test-tube, the drug appears to act nonspecifically, and can ‘switch on’ other latent virusesA small infective organism which is incapable of reproducing outside a host cell., including cytomegalovirus (CMV) and hepatitis B.

Although this has been only rarely reported in humans using the drug, Professor Lewin said this is one of a number of aspects that would have to be carefully researched in the longer term if the drug proceeds in further trials as an HIV treatment. For now, patients co-infected with hepatitis B are excluded from this initial study.

Participants are also required to be currently on treatment (but not a protease inhibitor), virologically suppressed for the last three years and have a stable CD4 count of greater than 500.

As with all early-phase studies, it’s worth bearing in mind that participation could affect your eligibility for trials of future treatments.

If you are in Melbourne and interested in participating, then speak with your doctor or contact the Alfred Infectious Diseases Unit Clinical Research Team on 03 9076 6908.