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Investigational Amdoxovir Plus Zidovudine Rapidly Reduces HIV Levels in Preliminary Test: Presented at CROI

By Ed Susman

BOSTON, MA -- February 7, 2008 -- The experimental nucleoside reverse transcriptase inhibitor amdoxovir appears to lower HIV levels rapidly when the new drug is combined with zidovudine, according to a preliminary trial.

"Patients dosed with the combination of amdoxovir 500 mg and zidovudine 200 mg twice a day achieved a 2-log10 reduction in circulating copies of HIV after 10 days," said Robert Murphy, MD, professor of infectious diseases at Pierre et Marie Curie Université-Paris VI, Hôpital Pitié Salpêtrière, Paris, France.

"Amdoxovir and the combination of amdoxovir and zidovudine were safe, effective and well tolerated," Dr. Murphy said at his poster presentation on February 4 during the 15th Conference on Retroviruses and Opportunistic Infections (CROI).

The 10-day trial enrolled 24 subjects who were naive to antiretroviral therapy and who had HIV RNA viral loads in excess of 5000 copies/ml. They were randomized to receive amdoxovir 500 mg twice a day, amdoxovir 500 mg plus zidovudine 200 mg twice a day, or amdoxovir 500 mg plus zidovudine 300 mg twice a day. The study was designed to determine the pharmacokinetics and pharmacodynamics of the new antiretroviral agent.

Dr. Murphy said the administration of amdoxovir plus zidovudine 200 mg resulted in the greatest decrease in HIV levels, with the 2-log 10 nadir reached on the final day of treatment. Amdoxovir monotherapy achieved a reduction of about 1 log10; zidovudine 200 mg alone produced a decrease of 0.7 log 10. The zidovudine dose of 300 mg did not appear to be as effective as the 200 mg dose. Subjects receiving placebo in the study did not show any decrease in HIV levels.

The researchers did not detect any changes in biochemistry, hematological or urinalysis parameters studied, Dr. Murphy said. "Longer studies with coformulated amdoxovir and zidovudine are warranted to confirm and extend the results of the current study," he said.

Amdoxovir is being developed by RFS Pharma LLD, Tucker, Georgia, which provided funding for the study with the National Institutes of Heath, Bethesda, Maryland, the Veterans Affairs Medical Center, and the Emory Center for AIDS Research, Atlanta, Georgia.


[Presentation title: Pharmacokinetics and Potent Anti-HIV-1 Activity of Amdoxovir Plus Zidovudine in a Randomized Double-Blind Placebo-Controlled Study. Abstract 794]

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