About this trial
This study will compare the effect of the new integrase inhibitor, raltegravir, with that of low-dose ritonavir on triglyceride and lipid (fat) levels. Volunteers who don't have HIV will be given either 100mg of ritonavir once a day or 400mg of raltegravir twice a day for 4 weeks.
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.
| Official title: | Post-parandial lipid effects of MK-0518 (raltegaravir) vs low-dose ritonavir (100mg daily) in HIV-negative adults |
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| What is this trial studying? | New drug |
| Start date: | February 2008 This may be the proposed or expected start date for trials which have not yet started. |
| How many participants will this trial enrol? | 20 The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic. |
| How long is this trial planned to go for? | Participants in this trial will be asked to take the trial drug for 4 weeks. |
| Who can enrol in this trial? | You may be eligible to participate in this trial if you meet the following criteria:
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| Links to further information: | |
| Can I access this treatment other than by enrolling in this trial? | Raltegravir is listed on PBS from 1 July 2008 |
| Keywords: | HIV-negative, integrase inhibitors, lipids, raltegravir, ritonavir |
If you are interested in enrolling in this trial
Before making the decision to participate in any clinical trial, NAPWA recommends that you discuss the potential benefits and risks of participation with your treating doctor. Your doctor can also provide advice about your eligibility to participate in the trial.
- You can print this page to take it with you to the doctor – just use your browser's 'print' function.
- Before making the decision to participate in any clinical research, read our background information.
- Email NAPWA if you have any questions or comments about this trial
- Call the Treataware info line if you need further advice
This Backgrounder looks at the science behind clinical trials and the reason why controlled scientific experiments are needed to answer scientific questions.