A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
Status:
Terminated
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
This is a double-blind Phase 2a study to test the safety and efficacy of an investigational
HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once
daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing
antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized
to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15)
or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice
daily.
The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300
mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but
then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received
amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in
the 36-week open-label study.