Second Line treatment trial begins

A treatment regimen consisting of one nonnucleoside (1NNRTI) and two nucleosides (2NRTIs) has become the internationally accepted first-line therapy of choice. But effective as the combination is, it doesn’t work for everyone. And those it fails need a reliable back-up.

This is particularly important in resourcepoor settings where CD4 counts and physical diagnosis are often the only monitoring methods available. By the time it has been established that the first-line therapy has not worked, the situation is often life-threatening and so it is imperative that the second-line does not fail.

The National Centre in HIV Epidemiology [1]The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population. and Clinical [2]Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. Research (NCHECR [3]National Centre in HIV Epidemiology and Clinical Research. Based at the University of NSW in Sydney, NCHECR is one of Australia's leading medical research centres and is recognised internationally as a leader in the field of research into HIV/AIDS and viral hepatitis. ) in Sydney is currently enrolling [4]The 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. people who have experienced a virological breakthrough while on their first-line (1NNRTI+2NRTIs). Half will be put on a regimen containing a boosted protease inhibitor plus 2NRTIs. The other half will be on a boosted protease inhibitor plus raltegravir (from the new drug class [5]A group of anti-HIV drugs with the same target of action. Anti-HIV drug classes include nucleoside analogue reverse transcriptase inhibitors, protease inhibitors and non-nucleoside analogue reverse transcriptase inhibitors, as well as several others. Combining drugs from three or more classes is the basis of Highly Active Antiretroviral Therapy (HAART). of integrase inhibitors).

Investigators will then be able to assess which of these combinations is safer, easier to take and better at controlling HIV. Chief investigator, Dr Mark Boyd is excited to be heading one of the first randomised [6]A method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant controlled trails anywhere to test two second-line options.

‘One of the nice things about Second Line is that the trial is of relevance to rich and poor countries alike,’ he said.

‘We have as little good-quality knowledge of how to manage first-line failure in Australia or Europe as we do in Nigeria or Thailand. So this is a genuinely collaborative trial which includes patients from high- and middle-income countries.’

For more information go to the NAPWA Clinical Trials database [7]