NAPWA

About this trial

This is the Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. study of raltegravir - from the new drug classA 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 which are designed to attack HIV in a different way to the other classes currently available on the Australian market.

The study compares an optimised background therapy used with and without raltegravir. Comparing results will allow the researchers to look at whether the addition of an integrase inhibitor is more effective against HIV than using the current drugs alone.

The study will also collect information about the safety of raltegravir, including any side effects, and how tolerable (easy) it is to take.

Background information

To infect a human host cell, HIV undertakes a complex enterprise. It must attach to the cell, fuse with it, and finally ‘reprogram’ the human cell with its own genetic material, producing new copies of itself and going on to infect more cells with new viral particles.

Theoretically, we can target this life cycle and attempt to interfere with HIV replication at any of a number of different points, often by inhibiting the enzymes which are crucial to a particular stage of the virus’s development.

Nucleoside/nucleotide reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors (NtRTIs and NNRTIs) work by targeting an enzyme called reverse transcriptase while protease inhibitors target a different enzyme called protease. Integrase inhibitors (e.g. raltegravir) work by inhibiting another enzyme, integrase, which HIV uses to integrate its genetic material with the host cell. Without this enzyme, HIV can’t reprogram the human host cell’s DNA, and its life cycle is cut short.

Integrase inhibitors have long been a kind of ‘holy grail’ for HIV drug development, and their arrival represents an important development. Used in combination with drugs from the other classes, this approach provides a fresh front for attacking HIV.

Like all other anti-HIV drugs, raltegravir is taken in combination with an optimised background therapy - a combination of HIV drugs chosen because it is the most likely to control HIV in the participants being studied.

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NAPWA commentary

This is a fully enrolledThe 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., ongoing study. There will be further studies to look at how this drug works in people who have not taken antiviralA medication or substance which is active against one or more viruses. May include anti-HIV drugs, but these are more accurately termed antiretrovirals. treatments before (treatment-naive).