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What is the most important information I should know about mozenavir?
- Mozenavir (DMP-450) is an experimental protease inhibitor being developed by Gilead Sciences. It was originally developed by Dupont Pharmaceuticals, hence the "DMP" in its experimental name. As of January 2002, development of this drug was halted by its manufacturer. Early data from clinical trials suggest that it would not likely have an advantage of any of the currently available protease inhibitors.
What is mozenavir?
- Mozenavir is an anti-HIV medication. It is in a category of HIV medicines called protease inhibitors. Mozenavir prevents cells infected by HIV from producing new virus. This reduces the amount of virus in your body.
- Mozenavir is being studied in two groups of HIV-infected people: patients who have never taken anti-HIV therapy before and patients who have failed at least one protease inhibitor in the past.
What is already known about mozenavir?
- The dose of mozenavir has not yet been determined, although it is expected to be taken twice a day.
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 Mozenavir is broken down (metabolized) by the liver differently than other protease inhibitors. In turn, mozenavir might not be associated with the types of drug interactions seen with other protease inhibitors. More information from studies are needed to determine which anti-HIV drugs and other treatments mozenavir can or cannot be taken with.
What is known about mozenavir for HIV-positive people who have never taken a protease inhibitor in the past?
- One clinical trial, conducted in Mexico and in Europe, has looked at three different doses of mozenavir (750mg three times a day, 250 mg three times a day, or 1250mg twice a day) in combination with Zerit® (d4T) and Epivir® (3TC). Also included in this study was a group of volunteers who took Crixivan, Zerit, and Epivir. Fifty volunteers were enrolled in this study, none of whom had taken anti-HIV drugs in the past. After 48 weeks of treatment, 70% of the volunteers who received Crixivan/Zerit/Epivir had undetectable viral loads (<50 copies/mL) compared to 77% of the volunteers who received the highest dose of mozenavir (1250mg twice-daily), Zerit, and Epivir. Study volunteers who received the highest dose of mozenavir also saw their T-cells increase, on average, by 200 after one year of treatment.
What is known about mozenavir for HIV-positive people who have taken at least one protease inhibitor in the past?
- No information is yet available from clinical trials evaluating the effect of mozenavir on viral load and T-cell counts in HIV-infected people who have taken other protease inhibitors in the past. Test tube study data suggest that mozenavir might not be very effective for patients who have taken – and failed – Crixivan® (indinavir) or Norvir® (ritonavir) in the past. However, it will be important to evaluate the potential benefit of this drug in clinical trials before any conclusions can be made.
What is known about side effects?
- In the study conducted in Mexico and Europe (see above), the most common side effects were diarrhea and nausea.
- Other side effects may occur as a result of taking mozenavir. These have not yet been fully examined in clinical trials and have not yet been reviewed by the FDA.
- A study involving dogs has shown that mozenavir can cause heart problems. However, the dose of mozenavir used in this study is approximately 15 times higher than the highest mozenavir dose being used in studies involving humans. None of the studies involving people infected with HIV have reported any heart problems.
Who should not take mozenavir?
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 It is not known whether mozenavir will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
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 It is not known whether mozenavir passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.
Where can I learn more about clinical trials of mozenavir?
- If you would like to find out if you are eligible for any clinical trials that include mozenavir, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
- Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).
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