Amdoxovir is currently being developed by RFS Pharma.
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Amdoxovir is being developed by RFS Pharma, a company based in Atlanta, Georgia. Amdoxovir has not yet been reviewed by the U.S. Food and Drug Administration.
What is amdoxovir?
Amdoxovir is an anti-HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Amdoxovir prevents HIV from entering the nucleus of healthy T-cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
There are currently two doses of amdoxovir being studied in clinical trials: 300mg and 500mg, both of which are taken twice a day.
Like other NRTIs, amdoxovir might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
According to test tube studies, amdoxovir may be active against strains of the virus already resistant to other NRTIs, including Retrovir (AZT) and Epivir (3TC). However, HIV that contains a key mutation (K65R) that results in resistance to Videx (ddI) and Viread (tenofovir) may be less sensitive to amdoxovir.
Amdoxovir will likely be studied and used in combination with other drugs, including another NRTI and at least one protease inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI).
What has been learned from clinical trials?
Amdoxovir is being studied in clinical trials involving HIV-positive people who are new to anti-HIV treatment and HIV-positive people who have tried and failed other NRTIs in the past. The results of one clinical trial have been reported.
DAPD-150 was a phase I clinical trial that enrolled 18 HIV-positive patients. These patients had been treated with several anti-HIV drugs in the past and were having a difficult time keeping their viral loads undetectable using a combination of anti-HIV drugs before entering the study. Once they were enrolled in the clinical trial, these 18 patients continued their current anti-HIV drug regimen and added either 300mg or 500mg amdoxovir, both of which were taken twice a day. After three months of therapy, patients who added 300mg amdoxovir to their regimen saw their viral loads fall by more than 90% (1.53 log). Patients who added 500mg amdoxovir saw their viral loads decrease by 0.75 log after 12 weeks of treatment.
Amdoxovir is currently being studied in a phase II trial (ACTG 5165) involving 40 HIV-positive patients who have been treated with several anti-HIV drugs in the past and were having a difficult time keeping their viral loads undetectable using their latest drug regimen. Once in the study, the patients will continue their latest drug regimen and will add either: 1) amdoxovir 500mg twice daily, or 2) amdoxovir 500mg twice daily plus mycophenolate mofetil (MMF; CellCept) 500mg twice daily, an immune-suppressant used for transplant patients (test tube studies suggest that it increases the anti-HIV activity of amdoxovir). The study will last 96 weeks.
Very early data from this study have been presented. In the patients combining their current regimen with amdoxovir, viral load decreased, on average, by 0.37 log after two weeks. Among patients who combined their current regimen with amdoxovir and MMF, viral load decreased, on average, by 0.23 log after two weeks. Ten of the 40 patients in both groups have seen their viral load decrease by 0.5 log or more. Longer-term follow-up data from this study will likely be presented throughout 2006 and 2007.
What is known about side effects?
There is not a lot of information about the potential side effects of amdoxovir.
In animal studies, amdoxovir caused kidney and eye problems. In DAPD-150, the phase I clinical trial discussed above, kidney problems were not seen. However, five patients were required to stop the drug because of eye problems (lenticular opacities), but these problems did not appear to have any affect on vision. More studies will be needed to better understand this possible side effect. In ACTG 5118, eye problems were no more likely to occur in people who took amdoxovir, compared to those who only received placebo.
Other side effects may occur as a result of taking amdoxovir. These have not yet been fully examined in clinical trials and have not yet been reviewed by the FDA.
Who should not take amdoxovir?
It is not known whether amdoxovir 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.
It is not known whether amdoxovir 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 amdoxovir?
If you would like to find out if you are eligible for any clinical trials that include amdoxovir, 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).
Last Revised: February 17, 2006
This content is written by the editorial team at AIDSmeds.com.
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amdoxovir
belongs to a class of anti-HIV drugs called 
Check My Meds
Like other NRTIs, amdoxovir might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
It is not known whether amdoxovir 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.
It is not known whether amdoxovir 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.